Dec 2, 2010

A newly released FDA report has been made available for public comment until October 4, 2010. The two preliminary reports, announced in the Federal Register on August 5, 2010 are organized into a two-volume set of documents entitled "Center for Devices and Radiological Health Preliminary Internal Evaluations" and "Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations." The specific objectives serve to implement the CDRH's primary goals, which are to foster medical device innovation, enhance regulatory predictability and improve patient safety. The specific objectives discussed throughout the report include:

  1. Streamline the premarket pathway for lower-risk novel devices.
  2. Enhance science-based professional development for CDRH staff.
  3. Establish a network of external experts to better inform the review of cutting-edge technologies.
  4. Increase the predictability of 510(k) data requirements by establishing a new "class IIb" category for certain devices.
  5. Create a new "Notice to Industry" tool to more rapidly communicate changes in premarket expectations.
  6. Clarify the meaning of key terms in the 510(k) "substantial equivalence" review standard to improve the consistency, transparency, and timeliness of the review process.
  7. Establish a Center Science Council as a new governance model to assure quality and consistency in CDRH's science-based decision making.
  8. Require the up-front submission of more complete safety and effectiveness information to support the review of 510(k) devices.
  9. Create a searchable online public database to provide more detailed, up‐to‐date medical device information to industry, the health care community, and patients.
  10. Clarify CDRH's 510(k) rescission authority and the circumstances under which a device should not be used as a predicate.

Of particular importance are the proposals to create a new, Class IIb classification (item 4 above) and an increase in provided clinical data on safety and effectiveness to support 510(k) submissions (item 8 above). In fact, the report describes the scenario where part way through a 510(k) review, the submitter is surprised by a request for clinical information "leading to avoidable delays."

The 510(k) Working Group has proposed a new "Class IIb" classification and corresponding guidance. "Class IIb" devices would typically require clinical or manufacturing data to support a substantial equivalence determination. Furthermore, the report delineates: "The development of a "class IIb" guidance document would help clarify, up front, what information submitters should include in their 510(k)s, so that they can plan accordingly. In so doing, it would help our review staff obtain, in a more efficient and predictable manner, the type and level of evidence they need to make reliable, well‐supported decisions."

Reports have circulated that approximately 8-10% of devices would fall under the "Class IIb" category. As one example, infusion pumps would likely meet the criteria. Additionally, the proposed recommendation for guidance on clinical data would be advantageous to manufacturers not typically accustomed to providing clinical data. In particular, manufacturers which would likely fall under "Class IIb" would benefit from these proposed guidelines as these manufacturers often experience delays when submitting 510(k) applications when clinical data is requested midway through the application process.

Incidentally, Emergo Group prepares numerous FDA 510(k) submissions for clients and we have observed closer scrutiny from the FDA with regard to clinical evidence. The review process, as a result, often takes longer than it did in the past. Therefore, what may have been required in the past to clear a device may not be in the future. Conversely, what may not have been required in the past may now be required for all submissions moving forward. One can no longer count on or assume that because the FDA cleared device X in the past with limited data, that device Y will also be cleared with the same limited data. We are seeing the FDA request clinical data for more and more devices which we have never seen previously.


  • Stewart Eisenhart