On January 19, 2011, FDA announced its long-awaited plans for revising the premarket notification (510(k)) process for medical devices to address the concerns that have been raised about the process by industry, consumers and Center for Devices and Radiological Health (CDRH) staff regarding the lack of predictability, consistency, transparency of the process, the inadequacy of the process to ensure the safety and effectiveness of products, and the lack of flexibility of the process to address changing technology and complexity. In 2009, CDRH established working groups to address these concerns. In August 2010, these working groups issued recommendations, which FDA analyzed and addressed as part of the announcement. FDA also sought public input and comments.

FDA’s Plan of Action for 510(k)s includes 25 action items for 2011, which include the majority of the working group recommendations that received overall support from the comments submitted to FDA. FDA states that it will focus first on implementing steps that will significantly impact fostering medical device innovation, enhancing regulatory predictability and improving patient safety. These steps include streamlining the review process for innovative, lower risk products (the “de novo” process), improving training for CDRH staff and industry, increase reliance on external experts, as well as addressing and improving CDRH processes. The Plan of Action includes an ambitious agenda to publish eight specific draft guidance documents between June – December 2011, on topics including:

  1. What changes do or do not warrant submission of a new 510(k) and which modifications are eligible for a Special 510(k);
  2. Clinical trials;
  3. Class III designation (de novo);
  4. Appropriate use of consensus standards;
  5. Appealing CDRH decisions;
  6. The 510(k) paradigm, to provide clarity on when clinical data should be submitted, submission of photographs or schematics, appropriate use of multiple predicates, criteria for identifying “different questions of safety and effectiveness,” resolving discrepancies between the 510(k) flowchart and the Federal Food, Drug, and Cosmetic Act, “intended use,” and 510(k) summaries;
  7. Pre-submission interactions with CDRH; and
  8. Product codes.

FDA announced that it intends to implement other recommendations, but only after stakeholder input. These recommendations include developing an online repository of medical device labeling and a public database of cleared devices that includes a photograph of each cleared device, while avoiding the disclosure of proprietary information. FDA also stated that it will further explore some of the other working group recommendations.

Finally, FDA identified some of the working group recommendations that were more controversial, such as consolidating the terms “indication for use” and “intended use,” expanding FDA statutory authority to consider off-label use when determining the intended use of a device and to require postmarket surveillance studies as a condition of clearance for certain devices, among others. FDA stated it will wait to decide whether to implement these recommendations until it receives feedback from the Institute of Medicine (IOM) as part of the IOM independent review of the 510(k) program that is currently underway.

Click here to view a copy of the Plan of Action for Implementation of 510(k) and Science Recommendations, which includes a description of the action item and date of completion.