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Navigating the FDA regulatory landscape

Neuropsychopharmacology volume 49, pages 18–22 (2024)Cite this article

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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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Authors and Affiliations

  1. Food and Drug Administration, Center for Devices and Radiological Health, Office of Product Evaluation and Quality, Office of Neurological and Physical Medicine Devices, 10903 New Hampshire Ave., Silver Spring, MD, 20993, USA

    Pamela D. Scott, Anita Bajaj & David P. McMullen

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  1. Pamela D. Scott
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  2. Anita Bajaj
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  3. David P. McMullen
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Contributions

PDS wrote and edited the manuscript, AB wrote the Patient Perspectives section and contributed to editing the manuscript, DPM wrote the introduction, contributed to the Special Programs section and the Novel and Rapid treatments for Psychiatric disorders section, and edited the manuscript.

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Correspondence to Pamela D. Scott.

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The authors declare no competing interests.

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Scott, P.D., Bajaj, A. & McMullen, D.P. Navigating the FDA regulatory landscape. Neuropsychopharmacol. 49, 18–22 (2024). https://doi.org/10.1038/s41386-023-01723-z

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