FDA Publishes Changes to Premarket Review Standards

Effective March 8, the US FDA has issued modifications to the list of standards used by the agency in its premarket review process for medical devices. The FDA’s move is intended to help device manufacturers that declare conformity with nationally and internationally developed consensus standards comply with associated requirements, according to the regulator’s Federal Register notice. Changes to these standards will affect the following medical device product groups:

  • Anesthesia
  • Biocompatibility
  • Cardiovascular
  • Dental/ENT
  • General hospital/plastic surgery
  • IVD
  • Materials
  • OB-GYN/gastroenterology
  • Orthopedics
  • Physical medicine
  • Radiology
  • Software
  • Sterility

Updated consensus standards will be added to the FDA’s searchable database. Although the new changes have already gone into effect, the agency is accepting comments on an ongoing basis. Medical device manufacturers whose products fall under any of the 13 categories listed above should familiarize themselves with how the FDA’s modifications may impact premarket reviews of their applications.

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