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Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin.” FDA has developed this draft guidance to propose select updates to FDA's current thinking regarding the type of biocompatibility information that should be provided in a premarket submission for certain devices made from common polymers and fabrics that are in contact with intact skin. This draft guidance is not final nor is it in effect at this time.
Submit either electronic or written comments on the draft guidance by December 14, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2013-D-0350 for “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
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 Submit written requests for a single hard copy of the draft guidance document entitled “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin” to the Office of Policy, Guidance and Policy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.
Jennifer Goode, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1656, Silver Spring, MD 20993-0002, 301-796-5701.
Many devices have intact skin contacting component materials that are made from polymers and fabrics. FDA believes these materials pose a very low biocompatibility risk because they have a long history of safe use in medical devices that contact intact skin. For such devices, significant FDA review resources are expended to obtain sufficient rationales to justify omission of biocompatibility testing for frequently used intact skin contacting medical devices, consistent with FDA's recommendations in the FDA guidance “Use of International Standard ISO 10993-1, ‘Biological evaluation of Medical Devices—Part 1: Evaluation and testing within a risk management process' ” ( https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and).
This select update describes a least burdensome approach for these devices that recommends specific material information in a premarket submission in lieu of biocompatibility testing. This approach also supports the principles of the “3Rs,” to reduce, refine, and replace animal use in testing when feasible. This approach is partially based on FDA's experience with these common polymers and fabrics. This approach also relies on certain parts of the Quality System Regulation (21 CFR part 820) and other postmarket controls that already require compliance ( e.g.,21 CFR part 803) to identify potential biocompatibility-related issues.
After FDA finalizes this guidance, FDA intends to periodically reassess the list of component materials and exclusion characteristics identified in this guidance. FDA requests that external stakeholders submit comments to the docket to suggest the addition or removal of component materials or exclusion characteristics from this policy, including a rationale. FDA intends to review comments received in the docket and periodically assess whether any changes to this policy are warranted. When FDA believes changes are warranted, FDA will issue updated guidance in accordance with the procedures in the Good Guidance Practices Regulation (21 CFR 10.115).
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin.” 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.
Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of “Select Updates for Biocompatibility of Certain Devices in Contact with Intact ( printed page 65412) Skin” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 19007 to identify the guidance you are requesting.
This draft guidance refers to previously approved collections of information. 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. 3501-3521). The collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the following table:
| 21 CFR part or guidance | Topic | OMB control No. |
|---|---|---|
| 807, subpart E | Premarket notification | 0910-0120 |
| 814, subparts A through E | Premarket approval | 0910-0231 |
| 814, subpart H | Humanitarian Device Exemption | 0910-0332 |
| 812 | Investigational Device Exemption | 0910-0078 |
| “De Novo Classification Process (Evaluation of Automatic Class III Designation)“ | De Novo classification process | 0910-0844 |
| “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff“ | Q-submissions | 0910-0756 |
| 800, 801, and 809 | Medical Device Labeling Regulations | 0910-0485 |
| 803 | Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user facility reporting, distributor reporting | 0910-0437 |
| 820 | Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation | 0910-0073 |
Dated: October 8, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22876 Filed 10-14-20; 8:45 am]
BILLING CODE 4164-01-P
7 comments have been received at Regulations.gov.
Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Submitted comments may not be available to be read until the agency has approved them.