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Compliance In Focus
Posted by John Lehmann on Wed, Apr 22, 2015

FDA Still Honing Medical Device Regulatory Process

Margaret_HamburgFormer FDA Commissioner Margaret Hamburg says FDA is still honing its medical device regulatory process so it strikes a balance between patient safety and industry’s desire to market their products. Speaking at the National Press Club in Washington D.C., which might be her last public appearance as commissioner. She indicated that she is not sure the U.S. or Europe have gotten the balance right yet.

Reflecting on Margaret Hamburg's Tenure

During her tenure as commissioner, many in the device industry have complained that Europe’s decentralize regulatory process better supported innovation because it was quicker and more transparent. Yet, Europe is in the middle of efforts to reform its system in response to findings that it is too lax in ensuring products safety.

Many in the FDA have been critical of the European system, indicating that lower testing standards have resulted in safety problems that have been avoided in the U.S. and that patient access to innovative devices is not necessarily better in Europe. Hamburg feels that neither U.S nor Europe has gotten completely right.

At the event, Hamburg acknowledges that the agency often takes strong criticism from stakeholders who either complain that they are hurting patients and industry by overregulating or putting the public in danger by not having more stringent requirements to approve medical devices. She acknowledges that balancing risks and benefits, a fundamental role of the FDA, is challenging. 

Hamburg feels that FDA has made progress during her six year tenure. She feels that  she is leaving a stronger, more engaged, more effective agency that is better positioned handle the challenges of the future. Hamburg also worries the agency is in danger of not being able to accomplish its mission due to underfunding. She would like to see the agency strengthened, not undermined.  “As I look forward I worry FDA has constantly been underfunded with responsibilities that outstrip the resources we get to do our job,” said Hamburg.

What is your opinion on Commissioner Hamburg’s tenure and the current state of the FDA?  Share your thoughts with us.

Photo Credit: Margaret Hamburg, Commissioner of Food and Drugs, May 18, 2010 Press Conference, UN Geneva via photopin (license)

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Topics: Margaret Hamburg, FDA, Medical Device Regulatory Process


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