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In Law360, Life Sciences Attorneys Examine Lessons From FDA Draft Guidance on Multifunctional Devices

Practices: Life Sciences, Health Care, FDA Regulatory, Digital Health

Capital Insights.

Life sciences co-chair and partner Gregory Levine (Washington, D.C.) authored a Law360 article published May 23 examining U.S. Food and Drug Administration draft guidance on the regulation of multiple function devices consistent with the 21st Century Cures Act.

 The authors note the FDA draft guidance emphasizes the need for manufacturers of products that contain multiple functions to carefully consider design and architecture early in product development.

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