In Law360, Life Sciences Attorneys Examine FDA Draft Guidance on Medical Device Inspections

Life sciences partner Greg Levine, counsel Beth Weinman and associate Joshua Oyster (all of Washington, D.C) authored a Law360 article published on May 10. The article examines two recent U.S. Food and Drug Administration draft guidances on inspections of medical device manufacturers, including the process for firms to request nonbinding, post-inspection FDA feedback on proposed corrective actions.

The authors note that the FDA draft guidances interpret certain statutory provisions in a way that is more restrictive and less impactful than the industry may have anticipated. As a result, the practical value of these reforms have may be limited unless the FDA revises the draft guidances.