Update on CDRH and The 510K Reform Process

Written by Nancy Tomoney - Associate Validation Manager, QPharma

In 2009, in response to fraud and device recalls associated with the 510K approval of medical devices at CDRH, FDA began a process of review of CDRH’s 510K approval process. The evaluation was completed in June 2010, and the report submitted for FDA review and government approval. The report was issued on August 4, 2010 in two parts.

The FDA’s evaluation of the medical devices process consists of two separate reports with their recommendations and is an outcome of internal discussions, public meetings and external discussion with industry. The evaluation consists of two reports:

Report #1: The CDRH Preliminary Internal Evaluations -- Volume I: 510(k) Working Group Preliminary Report and Recommendations, focuses on ways to strengthen and clarify CDRH’s review process for 510(k) approval exempt from a full premarket approval (PMA) review.

 Report #2: The CDRH Preliminary Internal Evaluations -- Volume II: Task Force Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations, details CDRH’s use of science in decision-making,  focusing on adapting new scientific information while maintaining regulatory innovation.

Based on these reports FDA has identified three major tasks for improving medical devices: fostering device innovation, enhancing regulatory predictability, and improving patient safety. Each of these major tasks has its own sub tasks.

As a means of fostering device innovation, CDRH has identified three sub areas of concentration: streamlining the premarket pathway for lower-risk novel devices; enhancing science-based professional development for CDRH staff; and establishing a network of external experts to better inform the review of cutting-edge technologies.

In an effort to enhancing regulatory predictability, CDRH has identified four sub areas of concentration: Increase the predictability of 510(k) data needs by establishing a new “Class IIb.; Create a new “Notice to Industry” tool to more rapidly communicate changes in premarket expectations; 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 and establishing a Center Science Council as a new governance model to assure quality and consistency in CDRH’s science-based decision making.

To ensure improved patient safety, CDRH has identified three sub areas of concentration: requiring the up-front submission of more complete safety and effectiveness information to support the review of 510(k) devices; creating a searchable online public database to provide more detailed, up-to-date medical device information to industry, the health care community, and patients; and clarifying CDRH’s 510(k) rescission authority and the circumstances under which a device should not be used as a predicate.

The reports can be found on the FDA website at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm221166.htm

The tasks and identified sub tasks would certainly require a budgetary increase for CDRH to implement. The question becomes this: is the United States Congress willing to increase the already underfunded FDA budget? That question can be easily answered by the response of the United States Congress to Senate Bill S. 3690, A Bill to Provide for Additional Quality Control of Drugs, which was introduced on August 3, 2010 by Freshman Senator Michael Bennett (D-Colorado). The bill would amend and add new sections to the Food Drug and Cosmetic Act, specifically focused on quality in pharmaceuticals. The bill’s ability to come out of the Committee on Health, Education, Labor, and Pensions and be passed will speak to how seriously the current constituted government takes funding of the FDA. That bill and the list of CDRH reforms would requires serious funding and expansion of the FDA.