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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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.” This draft guidance explains the principal concepts that sponsors and other interested parties should consider when choosing to collect and submit patient preference information (PPI). The knowledge gleaned from the use of PPI could be used across the total product life cycle, including for review in investigational device exemption (IDE) applications, premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, De Novo classification requests, or premarket notifications (510(k)s). This draft guidance also discusses FDA's inclusion of PPI in its decision summaries and provides recommendations for the inclusion of such information in device labeling for certain devices. This draft guidance is not final nor is it for implementation at this time.
DATES:
Submit either electronic or written comments on the draft guidance by December 5, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-2015-D-1580 for “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.” 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 “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle” 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. Send one self-addressed adhesive label to assist that office in processing your request.
FOR FURTHER INFORMATION CONTACT:
David Gebben, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1316, Silver Spring, MD 20993-0002, 301-796-6461 or James Myers, 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
FDA is announcing the availability of a draft guidance entitled “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.” FDA believes that patients can and should bring their own experiences to bear in helping the Agency to evaluate the benefit-risk profiles of certain devices. This kind of input can be important to consider during FDA's decision-making for these devices across the total product life cycle.
This draft guidance proposes expanded recommendations to the 2016 guidance entitled “Patient Preference Information—Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling” (2016 PPI Guidance). Since the issuance of the 2016 PPI Guidance, there have been many developments in the use of PPI for devices, including an increase in industry-sponsored PPI studies provided to FDA for consideration as part of a benefit-risk assessment, and numerous collaborations between FDA scientists and a variety of interested parties to conduct PPI studies to inform clinical trial design and FDA decision making across a wide range of diseases, conditions, and device areas. In addition, FDA has cohosted or participated in numerous convenings and international collaborations to advance scientific methods and practical applications of PPI. Meanwhile, FDA has expanded its benefit-risk guidance framework to apply to the total product life cycle, including the submission and review of IDE applications, 510(k)s, PMAs, De Novo requests, and HDEs applications, and FDA decisions involving administrative, enforcement, and other actions. This expansion of the 2016 PPI Guidance is intended to reflect this broadened scope as well as developments in the field of health preference research.
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 “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.” 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. 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 “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI01500006 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 the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in the following table have been approved by OMB:
| 21 CFR part; guidance; or FDA form | Topic | OMB control No. |
|---|---|---|
| 807, subpart E | Premarket notification | 0910-0120 |
| 814, subparts A through E | Premarket approval | 0910-0231 |
| 814, subpart H | Humanitarian Use Devices; Humanitarian Device Exemption | 0910-0332 |
| 812 | Investigational Device Exemption | 0910-0078 |
| 860, subpart D | De Novo classification process | 0910-0844 |
| “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” | 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 |
| 50, 56 | Protection of Human Subjects and Institutional Review Boards | 0910-0130 |