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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.

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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 InformationWeek. "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.

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