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Senate Bill Would Modernize FDA MedTech Inspection Process


WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker after introduction in the U.S. Senate of bipartisan legislation (S. 404) to modernize FDA’s medical device inspections process:

“Both the medical technology industry and FDA recognize the need for a robust inspections process to help ensure the continued availability of safe and effective devices and diagnostics for patients.

“However, the agency’s current inspections process suffers from a lack of consistency, predictability and transparency, preventing both FDA and industry from addressing quality and compliance issues in an efficient manner.

“The legislation introduced today by Sens. Johnny Isakson (R-Ga.) and Michael Bennet (D-Colo.) will help modernize FDA’s inspections process through a risk-based approach that will focus the agency’s limited resources on facilities that have the most potential to impact public health, improving overall patient safety.

The legislation would also:

  • Establish a process for companies to address deficiencies more quickly and robustly;
  • Create a more focused and efficient inspection process for FDA;
  • Harmonize the inspection process to eliminate regional variations; and
  • Improve communications between FDA and companies to ensure timely implementation of any remediation plans.

“This legislation will lead to a higher level of patient safety and more efficient use of inspector time and effort, while not taking away any of FDA’s authority to inspect device manufacturing facilities.

“We commend Sens. Isakson and Bennet for their leadership on this issue, and look forward to working with FDA, Congress and other stakeholders in advancing this important bill.”