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FDA Announces 510(k) Changes
by MassDevice staff


Mar 22, 2011 | Free Downloads | email | Print

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The Food & Drug Administration reveals plans to implement 25 changes to its 510(k) medical device clearance program, but will hold off on any major moves until after the release of an Institute of Medicine report that's slated to drop this summer.

The Food & Drug Administration announced that it plans to make 25 changes to its 510(k) medical device clearance program this year, but will hold off on any major moves until after the release of an Institute of Medicine report scheduled for the summer.

The watchdog agency's Center for Devices and Radiological Health said it would implement changes including the streamlining of the "de novo" review process for lower-risk devices, more clarity on when medical device manufacturers must submit clinical data in a 510(k) submission and the creation of a council to improve regulatory science.

The Food & Drug Administration reveals plans to implement 25 changes to its 510(k) medical device clearance program, but will hold off on any major moves until after the release of an Institute of Medicine report that's slated to drop this summer.

Nearly half of the 55 changes the agency recommended in August 2010 were temporarily taken off the table. Among those were several of the most controversial elements, such as the ability to revoke 510(K) clearances, increased post-market surveillance and the establishment of a new classification for medical devices that would require the submission of clinical evidence.

Those changes will be decided following the release of the independent IOM review slated for this summer.

The decision to hold off on the more controversial recommendations reflects a cautious approach by the agency's new stewards, FDA head Dr. Margaret Hamburg and CDRH chief Dr. Jeffrey Shuren. The FDA logged more than 76 public comments after the release of the report, many of which opposed the changes from a variety standpoints.

The agency maintains that the changes will be a boon for the process by which the vast majority of medical devices are cleared for the U.S. market, delivering "a smarter medical device program that supports innovation, keeps jobs here at home and brings important, safe and effective technologies to patients quickly," according to a statement by Shuren.

In order to facilitate innovation in medical devices, Shuren said the FDA will:

  • Streamline the review process for innovative, lower-risk products, called the "de novo" process by Sept. 30.
  • Publish guidance for industry to clarify when clinical data should be submitted to increase predictability and transparency on July 31.
  • Develop a network of external experts who can use their knowledge and experience to help the agency address important scientific issues regarding new medical device technologies by Sept. 15.
  • Establish a new Center Science Council of senior FDA experts within the agency's medical device center to assure more timely and consistent science-based decision making. FDA will publish the charter for the council its website on March 31. The agency plans to publish initial results of a 510(k) audit by the council on June 15.

To bolster the safety of medical devices, Shuren said the FDA will:

  • Establish a public database of important device information, such as medical device photographs, labeling and summaries of the basis for the FDA's decision to clear specific devices. The database will be discussed at a public meeting taking place April 7 and 8.
  • Require a brief description of scientific information regarding the safety and effectiveness known to the manufacturer for select higher-risk devices on a case-by-case basis through device-specific guidance.


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