FDA working to improve device-review process

The Food and Drug Administration is trying to ensure medical-device companies don’t experience any more “Columbo moments,” Jeffrey Shuren, director of the agency’s center for devices and radiological health, said at the Medtech Investing conference in Minneapolis in May 2013.

Shuren didn’t delve into exactly what FDA reviewers and the TV homicide detective have had in common. However, he said the agency’s overall goal is to make sure companies don’t get last-minute surprise requests from the agency, or not know where they stand throughout the review process.

In the “Columbo” TV series (see video below), actor Peter Falk‘s was best known for his style of questioning murder suspects, particularly his habit of stopping on his walk out the door, turning around and saying, “Just one more thing.”  That would be followed by a probing question that tended to make the suspect quite nervous.

One approach the FDA will take to prevent such reactions among med-device firms will be to ensure that when a reviewer on a case is replaced, the new person isn’t allowed to take a different position on the product than the previous reviewer took, Shuren said.

Shuren was scheduled to attend the Medtech Investing conference in person, but had to appear via teleconference instead, due to budget cuts caused by sequestration.

The FDA has successfully taken steps to address complaints beyond last-minute surprises, including long reviews, he said.  Shuren noted that the agency has sharply reduced its backlog of applications for 510(k) product approvals.

One of the agency’s goals is to encourage companies to conduct more early clinical trials in the U.S. rather than overseas.  For now, most medical devices are approved in Europe first and may not hit the U.S. market for several more years.  He encouraged companies considering conducting feasibility studies of products overseas to contact the FDA first, saying businesses will get free advice and possibly avoid making big mistakes.

Shuren added that the agency also believes it has a role to play in making it easier for companies to work with insurers on receiving reimbursement coverage for medical devices.

REFERENCE:  Katharine Grayson; Staff reporter- Minneapolis / St. Paul Business Journal; May 13, 2013

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