2021-13360. Remanufacturing of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Remanufacturing of Medical Devices.” This draft guidance is intended to help clarify whether activities performed on devices are likely “remanufacturing.” This draft guidance also includes recommendations for information that should be included in labeling to help assure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life. This draft guidance is not final nor is it in effect at this time.

DATES:

Submit either electronic or written comments on the draft guidance by August 23, 2021 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

ADDRESSES:

You may submit comments on any guidance 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-2018-N-3741 for “Remanufacturing of Medical Devices.” 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 draft guidance document entitled “Remanufacturing of Medical Devices” 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 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:

Katelyn Bittleman, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4250, Silver Spring, MD 20993-0002, 240-402-1478; Joshua Silverstein, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 301-796-5155; or Stephen Ripley, 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

Many devices are reusable and need preventive maintenance and repair during their useful life. For these devices, proper servicing is critical to their continued safe and effective use. However, there is a lack of clarity regarding the distinction between “servicing” and “remanufacturing.” FDA has been working to gain additional perspectives on the distinction between “servicing” and “remanufacturing” and has undertaken several efforts to help promote clarity. FDA opened a docket for public comment (81 FR 11477) and held a public workshop (81 FR 46694) in 2016. Public comments submitted to this docket are searchable under FDA-2016-N-0436 (https://www.regulations.gov/​docket?​D=​FDA-2016-N-0436).In 2018, FDA issued a white paper, opened a public docket, and held a public workshop to facilitate public discussion on the distinction between servicing and remanufacturing. Public comments submitted to this docket are searchable under FDA-2018-N-3741 (https://www.regulations.gov/​docket?​D=​FDA-2018-N-3741). The white paper described FDA's initial thoughts about guiding principles, provided a flowchart with accompanying text for understanding the distinctions, and contained a complementary approach for software, as well as considerations for labeling, and examples utilizing the flowchart. FDA also included targeted questions throughout the white paper for which the Agency sought feedback. FDA concurrently opened a docket under FDA-2018-N-3741 and held a public workshop to discuss the white paper and obtain public comment before issuing draft guidance. FDA considered the comments from the public docket and discussions during the public workshop in developing this draft guidance.

Because of the apparent confusion between servicing and remanufacturing among entities performing these activities, FDA committed in the “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices” (https://www.fda.gov/​media/​113431/​download) to issue guidance that clarifies the difference between servicing and remanufacturing activities. To assist with this clarification, FDA focuses this draft guidance on those activities that are likely remanufacturing. The determination of whether the activities an entity performs are remanufacturing affects the applicability and enforcement of regulatory requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. FDA has consistently enforced requirements under the FD&C Act and its implementing regulations on entities engaged in remanufacturing, including but not limited to registration and listing, adverse event reporting, the Quality System regulation, and marketing submissions.

For activities involving components/parts/materials, FDA recommends the use of the flowchart in the draft guidance to help entities determine if their activities are likely remanufacturing. Although the servicing and remanufacturing definitions and guiding principles in this draft document apply to software, the flowchart should not be applied to changes involving software. FDA has instead identified several activities performed on software that are likely not remanufacturing. This draft guidance also includes recommendations for information that should be included in labeling to help assure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life. This draft guidance is not intended to adopt significant policy changes, but to clarify FDA's current thinking on applicable definitions, and clarify, not change, the regulatory requirements applicable to remanufacturers.

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 “Remanufacturing of Medical Devices.” 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 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 or from the Center for Biologics Evaluation and Research at https://www.fda.gov/​vaccines-blood-biologics/​guidance-compliance-regulatory-information-biologics/​biologics-guidances. This guidance document is also available at https://www.regulations.gov and at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents. Persons unable to download an electronic copy of “Remanufacturing of Medical Devices” may send an email request to [e-mail] to receive an electronic copy of the document. Please use the document number 17048 and complete title to identify the guidance you are requesting.

III. Other Issues for Consideration

FDA's white paper introduced a flowchart that the Agency was considering proposing in draft guidance. FDA requested public comment on this flowchart during our December 2018 workshop and through the Docket No. FDA-2018-N-3741. While FDA has considered all comments and made changes as appropriate, FDA received opposing comments that suggested either no flowchart or more detail than FDA provided in the white paper. FDA encourages all interested stakeholders to comment on their preferred approach to help determine whether activities are remanufacturing and their rationale for such, using the following options: (1) No flowchart; (2) a flowchart similar to that proposed by FDA in this draft guidance; and (3) a more detailed flowchart, such as that proposed in comment FDA-2018-N-3741-0036.

IV. Paperwork Reduction Act of 1995

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations and forms have been approved by OMB as listed in the following table:

21 CFR part; or FDA form	Topic	OMB control No.
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
807, subparts A through D	Electronic Submission of Medical Device Registration and Listing	0910-0625
807, subpart E	Premarket Notification	0910-0120
Form FDA 3670	Adverse Event Reports/MedSun program	0910-0471

Dated: June 15, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.