FDA Begins Overhaul of 510(k) Process

Jan 25, 2011   

This week, the FDA announced its plans to overhaul its system for reviewing and clearing medical devices. The plan, which contains 25 distinct actions that the FDA intends to implement in 2011, comes as a result of two internal working groups that were created by the FDAs Center for Devices and Radiological Health (CDRH) in 2009. The CDRH set up these groups in an effort to address widespread concerns regarding the FDAs premarket notification process.

Currently, the most utilized pathway for medical device manufacturers to gain FDA clearance necessary to market new devices is through the 510(k) process. This process requires submitters to provide highly-detailed information regarding the intended use of the device, including any safety issues posed and how the device compares to other devices that have already gained FDA approval or been cleared through this process. In what is known as “substantial equivalence,” the FDA issues a finding allowing new devices to come to market and is primarily based on the perceived link between the applicants submitted comparable devices and the applicant device. Conversely, if the FDA believes that the applicant device is not substantially equivalent to the comparable devices that were submitted, then the Agency will issue a determination of “NSE,” meaning that the device at issue is not substantially equivalent to a legally marketed device. A determination of NSE may be reached for a variety of reasons, including any perceived differences between the intended use of the comparable devices and the applicant device or added risks that bear on the devices safety. Because there have been ongoing concerns regarding the unpredictable and inefficient nature of the 510(k) process, including what truly leads the FDA to conclude a new device is not substantially equivalent, the FDA unveiled its plan to improve this process.

Aimed at increasing the efficiency of the 510(k) process, while ensuring that the safety of new devices on the market is not diminished, the FDA intends to take several actions in the coming year that may greatly impact the pathway for the approval of medical devices. For instance, the Agency plans to publish several draft guidance documents that are intended to create more transparency regarding FDA determinations. To this end, the FDA intends to provide guidance concerning when it believes clinical data should be submitted, what kinds of information supports “intended use,” and how comparable devices should be utilized in 510(k) submissions.

Additionally, the FDA intends to streamline its “de novo” review process, which may help lower-risk medical devices gain the clearance necessary to enter the market. This is particularly important for new devices that cannot point to clear comparable devices on the market but do not pose heightened risks to safety. The de novo process entails a review of a device submission after the Agency has made the initial determination that the device is not substantially equivalent to any currently being marketed. While de novo review has come under fire for being too complicated and time-consuming, the FDAs plan seeks to breathe new life into this underutilized process.

The FDAs review of medical devices through the 510(k) or PMA process is complex. Fuerst Ittleman has extensive experience successfully navigating medical devices through FDA review. For more information on FDAs review of medical devices, please contact us at contact@fidjlaw.com.