We support FDA’s inspection of regulated medical device facilities to determine their compliance with applicable laws such as the Federal Food, Drug, and Cosmetic Act and its implementing regulations. We share FDA’s goal of efficient inspections that provide FDA with needed information while minimizing the disruption of the inspected facility and preserving FDA and industry resources.

We believe that FDARA section 702, Improvements to Inspections Process for Device Establishments, supports this shared goal.  FDARA section 702 includes many inspection-improvement measures, such as:

  • Announcing inspections within a reasonable time before they begin, including the inspection type, a reasonable estimated timeframe, and notice of the records to be requested;
  • Aligning the duration of inspections conducted inside and outside the U.S. and minimizing inspection interruptions;
  • Regular communication between FDA and the facility operator while the inspection is underway; and
  • Nonbinding FDA feedback in some cases about steps proposed by the facility operator to respond to inspection findings.

FDARA section 702 requires FDA to issue guidance in early 2019 about how it will implement the processes and standards included in section 702. We look forward to reviewing and offering input on this guidance.