FDA Considers Changes To Medical Device Regulation

Agency looking into whether 510(k) approval process allows safe and effective devices to enter the market without stifling innovation.
Among the report's recommendations are:

-- There should be a major improvement to the regulatory pathway for lower-risk novel devices that cannot be cleared through 510(k), but which do not warrant the more rigorous premarket approval review applied to higher-risk devices. The report calls for major reforms in the implementation of this process -- called the de novo classification process. The recommendations include streamlining the process and clarification of CDRH's expectations for submissions that undergo this type of review.

-- The CDRH should develop a guidance document defining a subset of moderate-risk (Class II) devices, called Class IIb, for which clinical or manufacturing data typically would be necessary to support a substantial equivalence determination. This guidance document would help clarify what information submitters should include in their 510(k) submissions so that they can plan accordingly. In addition, this would also help the center's review staff obtain the type and level of evidence necessary to make well-supported decisions without as much need for time consuming follow-up requests for information.

-- The CDRH should consider revising regulations to explicitly require 510(k) submitters to provide a summary of all scientific information known or that the submitter should reasonably know regarding the safety and effectiveness of the device under review. This is not required now for 510(k) submissions and, as a result, relevant information may not be included in an initial submission. This summary would help CDRH review staff make decisions more efficiently, and potentially avoid extensive follow-up inquiries and questions.

-- The CDRH should develop a guidance document that clarifies when a device should not be used as a basis for further decisions, such as when the original device has been removed from the market because of safety concerns. The report also recommends that the center consider issuing a regulation that would clarify the circumstances under which it would exercise its authority to rescind a 510(k) clearance to remove an unsafe device from the market and preclude its use as a predicate for further decisions, and also consider whether additional authority is needed.

WellDoc's Sysko welcomes the preliminary report and said medical device companies need greater clarity on the classifications of potential products, as well as more concrete requirements and use-cases for determining product classification. Sysko also said that as technologies, like those in the telehealth sector, develop new products, these companies need to have a more thorough understanding of the 510(k) program.

"Working at the convergence of information technology and bio-science offers many challenges. First, a company must discern whether or not regulatory clearance is even necessary," Sysko said. "Unfortunately, determining when a system goes beyond a consumer product to an FDA regulated product or even one requiring prescriptive approval is not black and white. Second, it can be difficult for a small, emerging technology company to employ the appropriate resources to navigate the regulatory process," Sysko added.

The FDA said the report's findings are preliminary and the agency will solicit and review public comment on the recommendations before announcing any improvements that it intends to make.

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