87 FR 17 pgs. 4036-4037 - Patient Engagement in the Design and Conduct of Medical Device Clinical Studies; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability
Type: NOTICEVolume: 87Number: 17Pages: 4036 - 4037
Pages: 4036, 4037Docket number: [Docket No. FDA-2019-D-3846]
FR document: [FR Doc. 2022-01374 Filed 1-25-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-3846]
Patient Engagement in the Design and Conduct of Medical Device Clinical Studies; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; 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 "Patient Engagement in the Design and Conduct of Medical Device Clinical Studies." The Patient Engagement Advisory Committee (PEAC) recommended that FDA and industry develop a framework to clarify how patient advisors can engage in the clinical investigation process. This guidance focuses on the applications, perceived barriers, and common challenges of patient engagement in the design and conduct of medical device clinical studies.
DATES:
The announcement of the guidance is published in the Federal Register on January 26, 2022.
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-2019-D-3846 for "Patient Engagement in the Design and Conduct of Medical Device Clinical Studies." 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 "Patient Engagement in the Design and Conduct of Medical Device Clinical Studies" 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 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:
Michelle Tarver, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5608, Silver Spring, MD 20993-0002, 301-796-6884 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
[top] On October 11 and 12, 2017, the PEAC met to discuss and make recommendations regarding patient engagement into medical device clinical studies. The PEAC stated that some framework should be developed by FDA and industry to clarify how patient advisors can engage in the clinical study process. Based on this recommendation, FDA is pursuing various efforts of
While FDA acknowledges that patient engagement may be beneficial across the total product lifecycle, this guidance focuses on the applications of patient engagement in the design and conduct of medical device clinical studies. The guidance will: (1) Help sponsors understand how they can voluntarily use patient engagement to elicit experience, perspectives, and other relevant information from patient advisors (see definition in section IV) to improve the design and conduct of medical device clinical studies; (2) highlight the benefits of engaging with patient advisors early in the medical device development process; (3) illustrate which patient engagement activities are generally not considered by FDA to constitute research or an activity subject to FDA's regulations, including regulations regarding institutional review boards (IRBs); and (4) address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.
A notice of availability of the draft guidance appeared in the Federal Register of September 24, 2019 (84 FR 50047). FDA considered comments received and revised the guidance as appropriate in response to the comments, including clarifying terminology, adding additional background on patient engagement efforts at FDA, and clarifying how sponsors can obtain specific feedback from FDA on patient engagement plans and patient-centered study designs.
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 patient engagement in the design and conduct of medical device clinical studies. 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 and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Persons unable to download an electronic copy of "Patient Engagement in the Design and Conduct of Medical Device Clinical Studies" may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 18040 and complete title to identify the guidance you are requesting.
III. 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, guidance, and forms 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 |
| "FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act" | 513(g) Request for Information | 0910-0705 |
| "Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff" | Q-submissions | 0910-0756 |
| 56 | Institutional Review Boards | 0910-0130 |
Dated: January 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01374 Filed 1-25-22; 8:45 am]
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