Publications

5 Aug 2010

FDA advised: raise scientific standards, incorporate new science for medical device approvals

FDA Alert

Kimberly K. Egan
Stacy L. Taylor
Rebecca Jones McKnight

On August 4, 2010, FDA released two reports related to the Center for Devices and Radiological Health’s (CDRH) efforts to overhaul its regulation of medical devices – one recommending potential changes to the 510(k) clearance process and one on the utilization of science in regulatory decision making.

510(k) Working Group Preliminary Assessment

Most medical devices get to market using the 510(k) pre-market notification rules, which permit manufacturers of devices that are “substantially equivalent” to a legally marketed “predicate device” that was not subject to premarket approval (PMA) to forgo full clinical testing, among other things.  FDA convened a 510(k) Working Group in September 2009 “to evaluate the 510(k) program and explore actions CDRH could take to strengthen the program and improve the consistency of its decision making.” 

Of particular interest in the Working Group’s recommendations are the following points:

• The concept of “substantial equivalence” is ambiguous, has been interpreted differently over time and has been applied to an increasingly wide range of products.  CDRH should explain what “substantial equivalence” means more clearly for both review staff and industry.
• CDRH should explore the feasibility of considering off-label uses of marketed devices as part of its “substantial equivalence” analysis. 
• CDRH’s decisions about which marketed devices qualify as “predicate devices” is inconsistent and has resulted in some devices entering commerce with an unknown safety profile.  CDRH should consider establishing a procedure to disqualify a marketed device from being used as a predicate, especially when the device has been withdrawn from the market based on safety concerns. 
• CDRH should consider a rulemaking to define when it can rescind 510(k) clearance for a marketed device.
• CDRH should clarify when a modification to a marketed device requires a new 510(k) clearance and when it does not. 
• CDRH should streamline the de novo classification process for devices that lack a clear predicate, which may allow moderate risk devices that might otherwise be required to undergo the PMA process to be reviewed instead under 510(k).
• CDRH should exercise its authority to require post-marketing studies as a condition of approval more frequently.
• CDRH should explain the circumstances under which it will refuse to clear a device based on manufacturing concerns. 
• CDRH should develop a publicly available database to include verified 510(k) summaries, device schematics, and approved labeling for each cleared device.

If adopted by FDA, these changes could raise the scientific standards with which manufacturers must comply and could result in more devices getting to market through the PMA process, instead of the 510(k) process.  These changes, if adopted, could also result in FDA rescinding clearance for older devices if it determines that a safer, more efficacious, later generation alternative exists.

Task Force on Utilization of Science in Regulatory Decision Making Assessment

FDA convened the Task Force on the Utilization of Science in Regulatory Decision Making in September 2009 to help FDA incorporate emerging science into its decision-making process. 

The Task Force identified three different types of emerging science, each of which potentially demands a different regulatory response.  Evolving Information is new information about an existing device, an existing manufacturer, or other information over the devices life cycle that was not previously available to FDA.  Novel Technologies are technological advances with which FDA has no prior experience, such as nanotechnology or robotics.  New Scientific Methods include new tools that can help CDRH analyze device data.  The Task Force’s examples include applying Bayesian statistics to clinical trials, mining spontaneous adverse event reporting, identifying new biomarkers for disease, and observational data from public health databases.  The Task Force refers to each of these definitions collectively as “new science.”

The “new science” recommendations of particular interest to industry are as follows: 

• CDRH should develop guidance on device clinical trial design and should develop an internal team of clinical trial experts as part of the Center Science Council to focus specifically on device trials.
• CDRH should develop a “web-based network of external experts” to understand emerging science, novel technologies, and other scientific questions.  The Task Force urges CDRH to use social media as part of the network.
• CDRH should develop guidelines explaining when new scientific information requires agency action with respect to a specific device. 
• CDRH should send “Notice to Industry” letters whenever CDRH “has changed its regulatory expectations on the basis of new scientific information.”

Each of these reports is available here.

For more information about these reports or about medical device regulation generally, contact Kimberly K. Egan, Stacy L. Taylor or Rebecca J. McKnight.