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Review
. 2024 Jan;49(1):18-22.
doi: 10.1038/s41386-023-01723-z. Epub 2023 Oct 18.

Navigating the FDA regulatory landscape

Pamela D Scott  1 , Anita Bajaj  2 , David P McMullen  2
Affiliations
Review

Navigating the FDA regulatory landscape

Pamela D Scott et al. Neuropsychopharmacology. 2024 Jan.

Abstract

Recent research and technological developments have led to an expanding number of novel and rapidly acting therapeutics being developed across a variety of neuropsychiatric disorders. Novel medical devices range from implantable and non-invasive brain stimulating and recording technologies to digital therapeutics. This perspective provides an overview of FDA regulatory oversight for medical devices, including a discussion of regulatory pathways and the review of neuromodulation devices for psychiatric disorders. We highlight the importance of early engagement with FDA and special programs that may be useful to device developers participating in interactions with the FDA that are solution focused. We explore current novel and rapid treatments for psychiatric disorders and those on the horizon. Lastly, we provide considerations for developers in navigating the regulatory landscape for neuromodulation devices intended for psychiatric disorders, including approaches to incorporating patient perspectives.

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Conflict of interest statement

The authors declare no competing interests.

References

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    1. U.S. Food and Drug Administration (FDA). How to study and market your device. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulato... Accessed August 2023.
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    1. National Archives. Code of Federal Regulations 21 CFR Part 882. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-882?toc=1 Accessed August 2023.

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