{"description":"Documents matching 'drug studies device exemption'","count":2705,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=drug+studies+device+exemption&format=json&page=2","results":[{"title":"Investigator Responsibilities-Safety Reporting for Investigational Drugs and Devices; Guidance for Investigators, Industry, and Institutional Review Boards; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for investigators, industry, and institutional review boards (IRBs) entitled \"Investigator Responsibilities--Safety Reporting for Investigational Drugs and Devices.\" The guidance is intended to help clinical investigators comply with the safety reporting requirements for investigational new drug application (IND) studies and investigational device exemption (IDE) studies. As such, recommendations are provided in this guidance to help investigators identify safety information that needs to be reported to sponsors and IRBs. This guidance finalizes the draft guidance of the same title issued on September 30, 2021.","document_number":"2025-22869","html_url":"https://www.federalregister.gov/documents/2025/12/16/2025-22869/investigator-responsibilities-safety-reporting-for-investigational-drugs-and-devices-guidance-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-16/pdf/2025-22869.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-22869.pdf?1765806313","publication_date":"2025-12-16","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"availability. \n \n \n SUMMARY: \n The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for investigators, industry, and institutional review boards (IRBs) entitled “Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices.” The guidance is intended to help clinical investigators comply with the safety reporting requirements for investigational new drug application (IND) studies and investigational device exemption (IDE) studies. As such, recommendations are provided in this"},{"title":"Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing its intent to exempt from premarket notification requirements certain class II clinical toxicology test system devices. FDA is publishing this notice and requesting public comment in accordance with procedures established by the 21st Century Cures Act. This notice does not represent FDA's final determination with respect to the devices included in this document. FDA will review any comments submitted within the 60-day comment period and will further consider whether the exemption described in this notice should be modified prior to publication of its final determination in the Federal Register.","document_number":"2026-08499","html_url":"https://www.federalregister.gov/documents/2026/05/01/2026-08499/medical-devices-exemptions-from-premarket-notification-certain-class-ii-devices-request-for-comments","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-01/pdf/2026-08499.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08499.pdf?1777553117","publication_date":"2026-05-01","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"any changes to the device would not be likely to result in a change in the device's classification. FDA may also consider that, even when exempting devices from the 510(k) requirements, these devices would still be subject to general limitations of exemptions. FDA's determinations that premarket notification is not necessary to provide a reasonable assurance of safety and effectiveness for class II devices are often based on the Agency's knowledge of the devices, including past experience and relevant reports or studies on device performance (as appropriate)"},{"title":"Medical Devices With Indications Associated With Weight Loss-Premarket Considerations; Guidance for Industry and Food and Drug Administration Staff; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Medical Devices with Indications Associated with Weight Loss--Premarket Considerations.\" This guidance document provides recommendations regarding non-clinical testing and clinical study design for medical devices with indications for use associated with weight loss to support premarket submissions. The guidance also includes discussion on how FDA considers the benefit-risk analysis to support such indications.","document_number":"2026-04918","html_url":"https://www.federalregister.gov/documents/2026/03/13/2026-04918/medical-devices-with-indications-associated-with-weight-loss-premarket-considerations-guidance-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-13/pdf/2026-04918.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-04918.pdf?1773319510","publication_date":"2026-03-13","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":" \n \n 814, subparts A through E \n Premarket approval \n 0910-0231 \n \n \n 812 \n Investigational Device Exemption \n 0910-0078 \n \n \n 860, subpart D \n De Novo classification process \n 0910-0844 \n \n \n “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” \n Q-submissions and Early Payor Feedback Request Programs for Medical Devices \n 0910-0756 \n \n \n 800, 801, 809, and 830 \n Medical Device Labeling Regulations; Unique Device Identification \n 0910-0485 \n \n \n 820 \n Current Good Manufacturing Practice (CGMP); Quality System"},{"title":"Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments","type":"Notice","abstract":"The Food and Drug Administration (FDA) has identified a list of class II devices that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice and requesting public comment in accordance with procedures established by the 21st Century Cures Act. This notice does not represent FDA's final determination with respect to the devices included in this document. FDA will review any comments submitted within the 60-day comment period and will consider whether the list of class II devices should be modified prior to publication of its final determination in the Federal Register.","document_number":"2026-02377","html_url":"https://www.federalregister.gov/documents/2026/02/06/2026-02377/medical-devices-exemptions-from-premarket-notification-class-ii-devices-request-for-comments","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-06/pdf/2026-02377.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-02377.pdf?1770299117","publication_date":"2026-02-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"may limit an exemption from premarket notification requirements to devices that satisfy certain conditions within a device type when the Agency determines that the factors described in the Class II 510(k) Exemption Guidance (Ref. 1) do not weigh in favor of exemption for all devices within a generic type of device. Where a partial limitation of exemption has been identified in this notice (see table 2), FDA has determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for devices that fall outside"},{"title":"Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled \"Evaluation of Sex- Specific and Gender-Specific Data in Medical Device Clinical Studies.\" This document provides guidance on the study and evaluation of sex- and/or gender-specific data in clinical investigations or research involving one or more subjects to determine the safety or effectiveness of a device. The purpose of this guidance is to encourage science- driven consideration of sex and/or gender, as appropriate for both the scientific question being addressed and the intended use of the device, when designing medical device clinical studies and reporting data from such studies in accordance with legal requirements. This draft guidance is not final nor is it for implementation at this time.","document_number":"2024-31526","html_url":"https://www.federalregister.gov/documents/2025/01/07/2024-31526/evaluation-of-sex-specific-and-gender-specific-data-in-medical-device-clinical-studies-draft","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31526.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31526.pdf?1736171120","publication_date":"2025-01-07","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"approval \n 0910-0231 \n \n \n 814, subpart H \n Humanitarian Device Exemption \n 0910-0332 \n \n \n 812 \n Investigational Device Exemption \n 0910-0078 \n \n \n 860, subpart D \n De Novo classification process \n 0910-0844 \n \n \n “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” \n Q-submissions \n 0910-0756 \n \n \n 800, 801, and 809 \n Medical Device Labeling Regulations \n 0910-0485 \n \n \n 822 \n Postmarket Surveillance of Medical Devices \n 0910-0449 \n \n \n \n 50, 56 \n Protection of Human Subjects"},{"title":"Medical Devices; Exemptions From Premarket Notification: Class II Devices; Clinical Electronic Thermometers","type":"Rule","abstract":"The Food and Drug Administration (FDA, we, or the Agency) is publishing an order setting forth the Agency's final determination to exempt certain class II clinical electronic thermometers from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for such class II clinical electronic thermometers. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulations. FDA is amending the classification language within the Code of Federal Regulations for certain class II clinical electronic thermometers to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).","document_number":"2025-11207","html_url":"https://www.federalregister.gov/documents/2025/06/18/2025-11207/medical-devices-exemptions-from-premarket-notification-class-ii-devices-clinical-electronic","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-11207.pdf?1750164314","publication_date":"2025-06-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"determination is based, in part, on the Agency's knowledge of the device, including past experience and relevant reports or studies on device performance (as appropriate), the applicability of general and special controls, and the Agency's ability to limit an exemption. \n A. General Limitations of Exemptions \n The exemption from premarket notification established in this order applies only to those devices that have existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type (see § 880.9 (21 CFR 880.9))."},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with investigational device exemptions.","document_number":"2025-16066","html_url":"https://www.federalregister.gov/documents/2025/08/22/2025-16066/agency-information-collection-activities-proposed-collection-comment-request-investigational-device","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-22/pdf/2025-16066.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-16066.pdf?1755780312","publication_date":"2025-08-22","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"information technology. \n Investigational Device Exemptions Reports and Records—21 CFR Part 812 \n OMB Control Number 0910-0078—Extension \n \n This information collection supports implementation of section 520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)), which governs exemption for devices for investigational use. An investigational device exemption (IDE) allows a device to be used in investigations involving human subjects in which the safety and effectiveness of the device is being studied. For more information"},{"title":"Sponsor Responsibilities-Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled \"Sponsor Responsibilities--Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies.\" The guidance provides recommendations for sponsors and sponsor-investigators to comply with the requirements of investigational new drug application (IND) safety reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies. This guidance finalizes the draft guidance of the same title issued on June 28, 2021.","document_number":"2025-22870","html_url":"https://www.federalregister.gov/documents/2025/12/16/2025-22870/sponsor-responsibilities-safety-reporting-requirements-and-safety-assessment-for-investigational-new","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-16/pdf/2025-22870.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-22870.pdf?1765806313","publication_date":"2025-12-16","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"investigators entitled “Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies” (December 2012) (the 2012 final guidance) to help sponsors and investigators comply with safety reporting requirements for INDs and for BA/BE studies that meet the conditions for IND exemption under § 320.31(d)(3) (IND-exempt BA/BE studies). In 2015, FDA issued a draft guidance for industry entitled “Safety Assessment for Investigational New Drug Application Safety Reporting” (December 2015) (the 2015 draft guidance)"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Humanitarian Use Devices","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection related to humanitarian use devices (HUDs) and humanitarian device exemption (HDE).","document_number":"2025-14945","html_url":"https://www.federalregister.gov/documents/2025/08/07/2025-14945/agency-information-collection-activities-proposed-collection-comment-request-medical-devices","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-07/pdf/2025-14945.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-14945.pdf?1754484337","publication_date":"2025-08-07","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"as an “eCopy” via FDA's Center for Devices and Radiological Health (CDRH) Customer Collaboration Portal (\n https://www.fda.gov/medical-devices/industry-medical-devices/send-and-track-medical-device-premarket-submissions-online-cdrh-portal \n ). Instructions and information regarding eCopy submission are available on FDA's website at \n \n https://www.fda.gov/medical-\n \n devices/how-study-and-market-your-device/ecopy-medical-device-submissions\n \n and in the FDA guidance document, “eCopy Program for Medical Device Submissions” (\n https://www.fda.gov"},{"title":"Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle; Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.\" Patients provide valuable input to FDA in a variety of forms. This guidance describes the principles and concepts that FDA recommends sponsors and other interested parties consider when collecting and submitting patient preference information (PPI), discusses FDA's inclusion of PPI in its decision summaries, and provides recommendations for the inclusion of such information in device labeling for certain devices. PPI can be used in FDA decision making across the total product life cycle, including during review of investigational device exemption (IDE) applications, requests for a Breakthrough Device designation, premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, De Novo classification requests, premarket notifications (510(k)s), or for FDA decisions involving administrative, enforcement, or other actions.","document_number":"2026-06063","html_url":"https://www.federalregister.gov/documents/2026/03/30/2026-06063/incorporating-voluntary-patient-preference-information-over-the-total-product-life-cycle-guidance","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-30/pdf/2026-06063.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-06063.pdf?1774615515","publication_date":"2026-03-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"\n 0910-0231 \n \n \n 814, subpart H \n Humanitarian Use Devices; Humanitarian Device Exemption \n 0910-0332 \n \n \n 812 \n Investigational Device Exemption \n 0910-0078 \n \n \n 860, subpart D \n De Novo classification process \n 0910-0844 \n \n \n “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” \n Q-submissions and Early Payor Feedback Request Programs for Medical Devices \n 0910-0756 \n \n \n 800, 801, 809, and 830 \n Medical Device Labeling Regulations; Unique Device Identification \n 0910-0485 \n \n \n 50, 56 \n Protection"},{"title":"Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance entitled \"Use of Real- World Evidence to Support Regulatory Decision-Making for Medical Devices.\" FDA is issuing this guidance to clarify how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This final guidance supersedes the final guidance, \"Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,\" issued August 31, 2017, and provides expanded and updated recommendations.","document_number":"2025-23252","html_url":"https://www.federalregister.gov/documents/2025/12/18/2025-23252/use-of-real-world-evidence-to-support-regulatory-decision-making-for-medical-devices-guidance-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-18/pdf/2025-23252.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-23252.pdf?1765979123","publication_date":"2025-12-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Premarket approval \n 0910-0231 \n \n \n 814, subpart H \n Humanitarian Use Devices; Humanitarian Device Exemption \n 0910-0332 \n \n \n 812 \n Investigational Device Exemption \n 0910-0078 \n \n \n 860, subpart D \n De Novo classification process \n 0910-0844 \n \n \n 822 \n Postmarket Surveillance of Medical Devices \n 0910-0449 \n \n \n “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” \n Q-submissions and Early Payor Feedback Request Programs for Medical Devices \n 0910-0756 \n \n \n “Administrative Procedures for CLIA Categorization”"},{"title":"Medical Devices; Radiology Devices; Classification of Blood Irradiators","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA) is proposing to classify blood irradiator devices (product code MOT), unclassified preamendments devices, as follows: blood irradiator devices intended to prevent transfusion-associated graft-versus-host disease into class II (special controls) with premarket notification and blood irradiator devices intended to prevent metastasis into class III (premarket approval) to provide a reasonable assurance of safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is issuing a proposed order proposing to require the filing of a premarket approval application for blood irradiator devices intended to prevent metastasis.","document_number":"2026-05320","html_url":"https://www.federalregister.gov/documents/2026/03/18/2026-05320/medical-devices-radiology-devices-classification-of-blood-irradiators","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-18/pdf/2026-05320.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-05320.pdf?1773751519","publication_date":"2026-03-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"that these devices are substantially equivalent to device(s) of the same type that were in commercial distribution prior to passage of the Medical Device Amendments on May 28, 1976. On May 26, 2005, FDA cleared the Raycell X-ray Blood Irradiator device (K051065). The Raycell X-ray Blood Irradiator is the first device to include, in addition to an intended use for the prevention of TA-GVHD, a second intended use for the prevention of metastasis.\n 5 \n \n To date, FDA has cleared a total of 16 devices under product code MOT. Two of the devices are cleared"},{"title":"General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Software-Aided Adjunctive Diagnostic Devices for Use on Skin Lesions by Physicians Trained in the Diagnosis and Management of Skin Cancer","type":"Rule","abstract":"The Food and Drug Administration (FDA) is issuing a final order reclassifying optical diagnostic devices for melanoma detection (product code OYD) and electrical impedance spectrometers (product code ONV), both postamendments class III device types, into class II (special controls), subject to premarket notification. FDA is also renaming and codifying these devices under the new classification regulation named \"software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer.\" FDA is also establishing the special controls necessary to provide a reasonable assurance of safety and effectiveness of these devices.","document_number":"2026-05772","html_url":"https://www.federalregister.gov/documents/2026/03/25/2026-05772/general-and-plastic-surgery-devices-reclassification-of-optical-diagnostic-devices-for-melanoma","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-25/pdf/2026-05772.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-05772.pdf?1774356312","publication_date":"2026-03-25","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"for the current device type. Future devices would only fall within this device type, and thus be classified into class II subject to the special controls established in this final order, if the device is found to be “substantially equivalent” to a predicate software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer, which requires that the device have the same intended use and the same technological characteristics as the predicate device, or, if the device has different"},{"title":"Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators","type":"Rule","abstract":"The Food and Drug Administration (FDA) is issuing a final order to reclassify non-invasive bone growth stimulators (product codes LOF and LPQ), postamendments class III devices, into class II, subject to premarket notification. FDA is codifying the reclassification of these devices under the new classification regulation, \"non-invasive bone growth stimulator.\" FDA is also establishing the special controls necessary to provide reasonable assurance of safety and effectiveness of these devices.","document_number":"2026-07366","html_url":"https://www.federalregister.gov/documents/2026/04/16/2026-07366/physical-medicine-devices-reclassification-of-non-invasive-bone-growth-stimulators","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-16/pdf/2026-07366.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07366.pdf?1776257113","publication_date":"2026-04-16","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"appropriate endpoints. To support a demonstration of substantial equivalence, the study should also include sufficient evidence that the device performs equivalently to a legally marketed predicate device. If the subject device is not studied in conjunction with the predicate device, we recommend that the study design demonstrate a clinically meaningful and statistically significant improvement compared to an appropriate control (\n e.g., \n sham device). A side-by-side study could also be used to demonstrate substantial equivalence in clinically relevant"},{"title":"Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.\" This guidance document provides an overview of the mechanisms available to submitters through which they can request interactions with FDA related to medical device submissions. This guidance supersedes the document entitled \"Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program\" issued on June 2, 2023, and provides clarification and additional information on the scope of Q-Submission (Q-Sub) types, better delineation of how to obtain feedback for different types of questions (i.e., informal communication vs. Pre-Submission or other Q-Sub types), and improved examples.","document_number":"2025-09618","html_url":"https://www.federalregister.gov/documents/2025/05/29/2025-09618/requests-for-feedback-and-meetings-for-medical-device-submissions-the-q-submission-program-guidance","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-05-29/pdf/2025-09618.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-09618.pdf?1748436316","publication_date":"2025-05-29","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"0910-0231 \n \n \n 814, subpart H \n Humanitarian Use Devices; Humanitarian Device Exemption \n 0910-0332 \n \n \n 812 \n Investigational Device Exemption \n 0910-0078 \n \n \n 860, subpart D \n De Novo classification process \n 0910-0844 \n \n \n Form FDA 3601 “Medical Device User Fee Cover Sheet”; form FDA 3601(a), the “Device Facility User Fee Cover Sheet”; “FDA and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act” \n Medical Device User Fee Cover Sheet and Device Facility User Fee Cover Sheet—Form FDA 3601"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.","document_number":"2026-03857","html_url":"https://www.federalregister.gov/documents/2026/02/26/2026-03857/agency-information-collection-activities-proposed-collection-comment-request-investigational-device","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-26/pdf/2026-03857.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-03857.pdf?1772027116","publication_date":"2026-02-26","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)), which governs exemption for devices for investigational use. An investigational device exemption (IDE) allows a device to be used in investigations involving human subjects in which the safety and effectiveness of the device is being studied. For more information regarding IDE, please visit our website at \n \n https://\n \n www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide.\n \n \n FDA has promulgated regulations in part 812 (21 CFR"},{"title":"Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices","type":"Rule","abstract":"The Food and Drug Administration (FDA) is issuing a final order reclassifying qualitative hepatitis B virus (HBV) antigen assays (product code LOM), HBV antibody assays (product code LOM), and quantitative HBV nucleic acid-based assays (product code MKT), all of which are postamendments class III devices, into class II (special controls), subject to premarket notification. FDA is also establishing the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of these device types.","document_number":"2025-18082","html_url":"https://www.federalregister.gov/documents/2025/09/18/2025-18082/microbiology-devices-reclassification-of-antigen-antibody-and-nucleic-acid-based-hepatitis-b-virus","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-18/pdf/2025-18082.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-18082.pdf?1758113115","publication_date":"2025-09-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"mechanisms in place to monitor the post market safety of devices. FDA maintains the MDR database, MAUDE database, and Medical Device Recall database, which allows for additional post-market surveillance of these devices and helps to ensure continued safety for marketed devices. For example, manufacturers are required to report to FDA information that reasonably suggests that their device may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that the manufacturer markets would be likely to cause"},{"title":"Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA) is proposing to reclassify Mycobacterium tuberculosis cell-mediated immunity tests and Mycobacterium tuberculosis cell-mediated immune response enzyme-linked immunospot tests intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection (product codes NCD and OJN, respectively), both of which are postamendments class III devices (premarket approval), into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices.","document_number":"2026-06064","html_url":"https://www.federalregister.gov/documents/2026/03/30/2026-06064/microbiology-devices-reclassification-of-mycobacterium-tuberculosis-cell-mediated-immunity-tests-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-30/pdf/2026-06064.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-06064.pdf?1774615515","publication_date":"2026-03-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"related to performance studies. Examples of information to be included in the design verification and validation documentation for the device include documentation of analytical studies and device performance data from clinical studies. In addition, design verification and validation documentation would be required to include a detailed description of the device, all critical reagents, a risk analysis demonstrating how risk control measures are implemented to address device hazards, lot release criteria, and stability studies. Required statements"},{"title":"Immunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product; Proposed Amendment; Proposed Order; Request for Comments","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA) is proposing to reclassify certain postamendments class III nucleic acid-based test systems indicated for use with a corresponding approved oncology therapeutic product (product codes OWD, PJG, PQP, and SFL) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation, along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices.","document_number":"2025-21071","html_url":"https://www.federalregister.gov/documents/2025/11/25/2025-21071/immunology-and-microbiology-devices-reclassification-of-nucleic-acid-based-test-systems-for-use-with","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-25/pdf/2025-21071.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-21071.pdf?1763991946","publication_date":"2025-11-25","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"of devices are class I (general controls), class II (special controls), and class III (premarket approval). \n \n Section 513(a)(1) of the FD&C Act defines the three classes of devices. Class I devices are those devices for which the general controls of the FD&C Act (controls authorized by or under section 501, 502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h, 360i, or 360j) or any combination of such sections) are sufficient to provide reasonable assurance of safety and effectiveness of the device; or those devices for"},{"title":"Determination of Regulatory Review Period for Purposes of Patent Extension; [CHOCOLATE TOUCH (PACLITAXEL DRUG COATED PTA BALLOON CATHETER)]","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CHOCOLATE TOUCH (PACLITAXEL DRUG COATED PTA BALLOON CATHETER) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.","document_number":"2025-12340","html_url":"https://www.federalregister.gov/documents/2025/07/02/2025-12340/determination-of-regulatory-review-period-for-purposes-of-patent-extension-chocolate-touch","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-02/pdf/2025-12340.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-12340.pdf?1751373915","publication_date":"2025-07-02","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 240-402-6940. \n \n \n \n SUPPLEMENTARY INFORMATION: \n I. Background \n The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive)"}]}