FDA must better define what it considers "new science" when deciding how to incorporate emerging data into product reviews and post-market surveillance, and must vet the data carefully before reacting, device companies say. Read more...
In recent comments to the agency, device industry reps caution that all emerging data about a device or device type does not qualify as "valid scientific evidence" and thus should not affect FDA's regulatory decision-making.
FDA is reassessing how it incorporates new scientific information into regulatory decisions, seeking input on the topic in a December 2009 Federal Register notice and Feb. 9 public workshop (The Gray Sheet' Feb. 15, 2010).
Validating New Scientific Evidence
Device trade group AdvaMed says it would be "inappropriate" to change pre- or post-market requirements based on "anecdotal or incomplete or improperly derived observational data," without first confirming and validating the safety issues presented.
If FDA discovers an emerging safety concern through a pattern of adverse event reports, for example, it must first determine whether the problem is unique to one company's device or whether it's applicable to a class of devices, AdvaMed writes in Feb. 24 2 comments.
Some safety issues may be related to a manufacturing issue at one company, the group stressed.
If the problem appears to affect an entire device category, FDA should then perform a risk analysis and validate the MDR safety signals, device makers emphasized.
The Medical Device Manufacturers Association cautioned that many of the case studies presented at FDA's "new science" workshop were examples of data that should not be considered new science.
MDMA agreed, in Feb. 24 3 comments, that FDA should apply the same regulatory definition for "valid scientific evidence" that it uses in the product approval process.
FDA should also clarify that all new information will be viewed in light of the product's risk-benefit profile, MDMA said. Given the new information, the benefits of the device may still outweigh the risks, the group suggested.
Agency staffers should work closely with manufacturers throughout the evaluation process, the device industry reps emphasized.
Companies may already possess useful information on the new safety or efficacy concerns; otherwise they could work with FDA to collect that data, MDMA noted.
Above all, companies urged FDA to issue new or updated guidance "as quickly as possible" to reflect any changes in its regulatory standards for any given device type.
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