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GUIDANCE DOCUMENT

Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders September 2019

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-3846


Docket Number:
FDA-2019-D-3846
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

The U.S. Food and Drug Administration (FDA or the Agency) values the experience and perspectives of patients and their family caregivers. FDA believes that these individuals can and should be able to provide their insights about a disease or condition, including living with that disease/condition, and the impact of medical devices in the diagnosis, treatment, and management of the disease/condition, through engagement activities. Such activities can assist the Agency in understanding the patient experience, as well as sponsors as they design and conduct medical device clinical investigations.  ("Clinical investigation" is defined in 21 CFR 50.3(c) and 56.102(c).)

This draft guidance is intended to:

  1. help sponsors understand how they can 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 investigations;
  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 investigation.