2023-19402. Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process”; Guidance for Industry and Food and Drug Administration Staff; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Use of International Standard ISO 10993–1, `Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process'.” This guidance was revised to incorporate 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. The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO 10993–1, “Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process” to support premarket approval applications (PMAs), humanitarian device exemptions (HDEs), investigational device exemption (IDE) applications, premarket notifications (510(k)s), and De Novo requests.

DATES:

The announcement of the guidance is published in the Federal Register on September 8, 2023.

ADDRESSES:

You may submit either electronic or written comments on Agency guidances at any time as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA–2013–D–0350 for “Use of International Standard ISO 10993–1, `Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process'.” 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, 240–402–7500.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

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 guidance document entitled “Use of International Standard ISO 10993–1, `Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process' ” to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT:

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; or Anne Taylor, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240–402–7911.

SUPPLEMENTARY INFORMATION:

I. Background

On September 4, 2020, FDA issued a guidance entitled “Use of International Standard ISO 10993–1, `Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process' ” (“2020 Biocompatibility Guidance”). The 2020 Biocompatibility Guidance was developed to assist industry with PMAs, HDEs, IDEs, 510(k)s, and De Novo requests for medical devices that come into direct contact or indirect contact with the human body to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body.

On October 15, 2020, FDA issued a draft guidance entitled “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin” (the Select Updates Guidance) which proposed updates to the 2020 Biocompatibility Guidance regarding the type of biocompatibility information that should be provided in a premarket submission for certain devices made from common synthetic polymers and natural fabrics that are in contact with intact skin. A notice of availability of the draft guidance appeared in the Federal Register of October 15, 2020 (85 FR 65410).

FDA is issuing this guidance to incorporate content from the Select Updates Guidance. FDA considered comments received to the Select Updates Guidance, and we revised the guidance as appropriate in response to the comments, including addition of materials to the list of those included in the policy and clarification of the following: applicability of the policy to device components, devices or components made from multiple materials, and materials including processing chemicals; situations where additional discussion on applicability of the policy is recommended; and clarification on characteristics of devices or materials to which this policy does not apply. In addition, FDA made minor updates to the guidance to align with the current recognized versions of consensus standards. This guidance supersedes the 2020 Biocompatibility 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 FDA on Use of International Standard ISO 10993–1, “Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process.” 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.

II. 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 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, https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents, or https://www.fda.gov/​vaccines-blood-biologics/​guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of “Use of International Standard ISO 10993–1, `Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process' ” may send an email request to [e-mail] to receive an electronic copy of the document. Please use the document number GUI00001811 and complete title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following table have been approved by OMB:

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
860, subpart D	De Novo classification process	0910–0844
“Requests for Feedback on Medical Device Submissions: The Q-Submission Program and Meetings with Food and Drug Administration Staff”	Q-Submissions and Early Payor Feedback Request Programs for Medical Devices	0910–0756
800, 801, 809, and 830	Medical Device Labeling Regulations; Unique Device Identification	0910–0485
803	Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user facility reporting, distributor reporting	0910–0437
822	Postmarket Surveillance of Medical Devices	0910–0449
820	Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation	0910–0073
58	Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies	0910–0119

Dated: September 5, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.