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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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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:
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-2020-D-1564
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
The objectives of this guidance are to:
- Describe principles that may be considered when using PRO instruments in the evaluation of medical devices (Section III);
- Provide recommendations about the importance of ensuring the PRO instruments are fit-for-purpose (Section III), and;
- Outline best practices to help ensure relevant, reliable, and sufficiently robust PRO instruments are developed, modified, or adapted using the least burdensome approach (Section IV).