The Food and Drug Administration is making changes to its process of reviewing certain medical devices before they go to market. The FDA says it will implement 25 actions this year, including streamlining the “de novo” review process for certain innovative, lower-risk medical devices; issuing guidance clarifying when clinical data should be submitted in a premarket submission; and establishing a new Center Science Council of senior FDA experts to ensure timely and consistent science-based decision making. According to the agency, the changes will encourage innovation while protecting patient safety and increasing transparency. Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, says:
The moves will create a smarter medical device program that supports innovation, keeps jobs here at home and brings important, safe and effective technologies to patients quickly.
The changes reflect some of the 55 recommendations made by two internal working groups set up by the agency to address concerns related to the premarket notification process. The groups found that the process for premarket review of lower-risk medical products such as certain catheters or diagnostic imaging devices – known as 501(k) – was unpredictable, inconsistent and opaque. Consumers and health care professionals commented that the review process wasn’t robust enough. The Center has also asked the independent, nonprofit Institute of Medicine to study the 501(k) review program. That review is still underway.
Source: Lawyers USA Online
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