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Mark E. Brager
March 28, 2017

AdvaMed Supports House Bill to Modernize FDA MedTech Inspections 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. House of bipartisan legislation (HR 1736) to modernize FDA’s medical device inspections process:

“FDA’s inspections process is crucial to helping ensure the continued availability of safe and effective devices and diagnostics for patients. Unfortunately, the current process in inconsistent, unpredictable and lacks transparency, which is detrimental for both the agency and industry in addressing quality and compliance issues efficiently.

“The legislation introduced today will help address these shortcomings, and we commend Reps. Larry Buschon (R-Ind.), Scott Peters (D-Calif.), Susan Brooks (R-Ind.) and G.K. Butterfield (D-N.C.) for their leadership on this issue.

“The legislation introduced in the House today, which mirrors Senate legislation released in February, will modernize FDA’s inspections process through a risk-based approach, directing the agency to focus its 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.

“FDA and the medical technology industry are united in their conviction that a robust inspections process benefits patients and innovation. 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 look forward to working with FDA, Congress and other stakeholders to advance this important bill.”