Public Meeting: Strengthening the CDRH’s 510(k) Review Process

In response to increasing criticism toward the premarket approval process from the U.S. Congress and the public, who believe that the program may allow products on the market without adequate safety and effectiveness review, the U.S. Food and Drug Administration (FDA) convened an internal working group to reevaluate and potentially modifying the 510(k) program. This working group held its first public meeting/workshop, Strengthening the Center for Devices and Radiological Health’s 510(k) Review Process, on February 18, 2010, seeking input from interested stakeholders on how to modify this program to improve it.

The participants included staff from the FDA Center for Devices and Radiological Health (CDRH), various public stakeholders who spoke on issues representing private third party activity, industry, and academia, and a roundtable discussion with experts that included Heart Rhythm Society Health Policy Committee member William H. Maisel, MD, MPH, FHRS, from the Medical Device Safety Institute; Susan Alpert, MD representing Medtronic; John Schalago from Pfizer Healthcare and Diana Zuckerman, MD, representing a patient advocacy group.

A 510(k) is a premarket submission made to FDA to demonstrate that a Class I, II, and III device can be as safe and effective, that is, substantially equivalent (SE), to a legally marketed device (i.e., predicate device), when the new device is not subject to a Premarket Approval (PMA). Submitters must compare their device to one or more similar legally marketed devices and make and support their substantially equivalent claims. The FDA receives more than 3,000 510(k) submissions each year.

Strengthening the Center for Devices and Radiological Health’s 510(k) Review Process gave an overview of key challenges from the premarket notification process (510(k)). Among the questions and challenges raised:

• How should the agency address a predicate that is no longer equivalent to today’s standards?
• Are there too many predicates? What criteria should the FDA use to refuse a predicate?
•  Is substantial equivalence (SE) still relevant in today’s world ?
• Should a risk-benefits ratio be the same for all devices?
• Should FDA request a manufacturer to define or include the indicated use of a device, not just the intended use of that device?
• How can FDA be more consistent during the review process – use of standardized symbols and language? 
• Should there be more transparency? (Manufacturers would like to be able to review why certain decisions are made and why there is inconsistency from decisions to similar manufacturers or similar devices)
• What ideas or better models are needed to help FDA create a more user-friendly system?  (Product codes are often hard to find, and changes to rules also hard to find) 
•  Should FDA standardize the process and use review teams that have a history of the predicate being reviewed?
•  At what point should the FDA change a PM decision based on the label of a product?

The FDA internal working group is currently accepting public comments on these issues. The Heart Rhythm Society will provide comments on the importance of transparency, standardization of the process, and analize and responst to some of the questions above by the March 19 deadline.

The working group is set to submit a report by the end of May to the Jeff Shuren, CDRH Director. The FDA will then release the report for public comment over the summer. FDA will decide which recommendations to adopt and begin implementing those recommendations by the end of September.

For more information on the workshop and to submit comments, please visit the FDA website.