FDA Considers Changes To Medical Device RegulationFDA Considers Changes To Medical Device Regulation

Last week, when WellDoc announced that it had received approval from the U.S. Food and Drug Administration's 510(k) program to market the WellDoc DiabetesManager System to healthcare providers and adult patients with type 2 diabetes, company officials were ecstatic.

"Having FDA clearance will prove to be a significant milestone that validates and differentiates the safety and efficacy of our system," Ryan Sysko, WellDoc's chief executive officer, told information. "Not all mHealth solutions will need 510(k), but those that really impact healthcare need to go this route."

Undoubtedly, receiving 510(k) clearance is a stamp of approval that opens doors for many medical device companies, including telehealth firms, to sell their products to the healthcare industry. Technologies like the DiabetesManager System, which supports medication adherence and provides for the capture, storage, and real-time transmission of blood glucose data and other diabetes self-management information by utilizing mobile phones and the Internet, are increasingly the types of technologies that come up for 510(k) review.

However, a new FDA report, also released last week, acknowledged that there are problems and calls for improvements to the current 510(k) program.

In recent years, concerns have been raised both inside and outside of the FDA about whether the current 510(k) program achieves its goals of making safe and effective devices available to the public while fostering innovation. The report sought to investigate these concerns, which centered on whether the program allows devices to enter the market without sufficient safety and effectiveness evidence and whether a lack of predictability, consistency, and transparency is hindering device development.

The report, published by the FDA's Center for Devices and Radiological Health (CDRH), "510(k) Working Group Preliminary Report and Recommendations," notes that there are a whole host of difficulties that the CDRH, which administers the 510(k) program, needs to address. 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.