This PDF is the current document as it appeared on Public Inspection on 06/30/2015 at 08:45 am.
Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements.” This guidance describes FDA's intent to exempt certain unclassified medical devices (that FDA intends to classify into class I or II), certain class II medical devices, and certain class I medical devices from premarket notification requirements. FDA believes the devices identified in this guidance document are sufficiently well understood and do not require premarket notification to assure their safety and effectiveness.
Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.
An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements” to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document.Start Further Info Start Printed Page 37634
FOR FURTHER INFORMATION CONTACT:
Angela C. Krueger, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993-0002, 301-796-6380.End Further Info End Preamble Start Supplemental Information
In the commitment letter (section 1.G of the Performance Goals and Procedures) that was drafted as part of the reauthorization process for the Medical Device User Fee Amendments of 2012, part of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), FDA committed to identifying low-risk medical devices to exempt from premarket notification requirements. This guidance describes FDA's intent to exempt certain unclassified medical devices (that FDA intends to classify into class I or II), certain class II medical devices, and certain class I medical devices (that no longer meet the “reserved” criteria in section 510(l) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(l))) from premarket notification requirements. FDA believes the devices identified in this guidance document are sufficiently well understood and do not require 510(k) notification to assure their safety and effectiveness.
The draft of this guidance was made available in the Federal Register on August 1, 2014 (79 FR 44804). The comment period closed on September 30, 2014. FDA received one comment on the draft guidance requesting that devices classified under 21 CFR 880.6760 (Protective restraint, product code OYS, Patient Bed with Canopy/Restraints) be considered for inclusion in the guidance document. FDA considered the comment and determined it was appropriate to add this device type to the final guidance.
In the process of finalizing the guidance document, the Center for Devices and Radiological Health (CDRH) reviewed additional medical device product codes not included in the draft guidance and determined that there were additional device types which are sufficiently well understood and do not require premarket notification (510(k)) to assure their safety and effectiveness. As a result, the following device types (product codes) were added to the final guidance document: EIB—Syringe, Irrigating (Dental); EWD—Protector, Hearing (Insert); EWE—Protector, Hearing (Circumaural); LEZ—Aids, Speech Training for the Hearing Impaired (AC-Powered and Patient-Contact); LFA—Aids, Speech Training for the Hearing Impaired (Battery-Operated or Non-Patient); KLX—Electroglottograph; LZI—Device, Assistive Listening; LRL—Cushion, Hemorrhoid; KMJ—Lubricant, Patient; OYS—Patient Bed with Canopy/Restraint (see above); HCD—Cannula, Ventricular; GYK—Instrument, Shunt System Implantation; LHM—System, Thermographic, Liquid Crystal; KYA—System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use); NUR—Pad, Interlabial; and LZW—Monitor, Spine Curvature.
Additionally, CDRH reviewed the device types (product codes) included in the draft guidance document and determined that two device types (product codes) originally proposed in the draft guidance document should not be included in the final guidance as devices for which FDA intends to exempt from premarket notification requirements: FLL—Thermometer, Electrical, Clinical (21 CFR 880.2910); and GWO—Plate, Cranioplasty, Preformed, Alterable (21 CFR 882.5320). CDRH determined that premarket notification (510(k)) is necessary to assure the safety and effectiveness of these devices. Notably, the FLL product code currently covers thermometers with a range of technologies and intended uses, including those used to screen for potential pandemic contagious diseases. CDRH believes that some thermometer types may be candidates for exemption from premarket notification requirements at a later date, but that thermometers should first be further categorized by technology and/or intended use into distinct product codes. CDRH is actively reviewing this issue and will further consider which of the sub-types may be appropriate to exempt from premarket notification requirements. In addition, CDRH believes that premarket notification (510(k)) is necessary to provide a reasonable assurance of safety and effectiveness for cranioplasty plates (GWO), which are permanent implants and may be constructed of polymeric materials and/or may be resorbable, because FDA must evaluate the material properties and resorption rate in relation to bone healing. CDRH recognizes that manufacturers may not have submitted a 510(k) for these two device types following publication of the draft guidance. As a result, CDRH is providing such manufacturers 90 days following the publication of this notice to submit a 510(k) for these device types; however, distribution and marketing of such devices must cease if a manufacturer receives an order from FDA declaring the device to be not substantially equivalent to any legally marketed predicate device. Finally, CDRH changed the product code listed in the guidance document for Ophthalmic Cameras (21 CFR 886.1120) from HKI—Camera, Ophthalmic, AC-Powered to PJZ—Camera, Ophthalmic, AC-Powered, General Use to clarify the type of AC-powered Ophthalmic Camera CDRH intended to exempt. CDRH also removed LQX—Device, Finger-Sucking (21 CFR 890.3475) from the final guidance because this device type is already classified as class I (general controls) and exempt from premarket notification. Finger-sucking devices (LQX) and cranioplasty plates (GWO) were unintentionally included in the draft guidance.
III. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of the FDA on the Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
IV. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1300046 to identify the guidance you are requesting.
V. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart E, have been Start Printed Page 37635approved under OMB control number 0910-0120.
Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.Start Signature
Dated: June 26, 2015.
Associate Commissioner for Policy.
[FR Doc. 2015-16150 Filed 6-30-15; 8:45 am]
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