FDA Considers Changes To Medical Device Regulation - InformationWeek
Healthcare // Analytics
11:59 AM
Building Security for the IoT
Nov 09, 2017
In this webcast, experts discuss the most effective approaches to securing Internet-enabled system ...Read More>>

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.

Slideshow: RFID In Healthcare
(click for larger image and for full photo gallery)
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.

1 of 2
Comment  | 
Print  | 
More Insights
Newest First  |  Oldest First  |  Threaded View
How Enterprises Are Attacking the IT Security Enterprise
How Enterprises Are Attacking the IT Security Enterprise
To learn more about what organizations are doing to tackle attacks and threats we surveyed a group of 300 IT and infosec professionals to find out what their biggest IT security challenges are and what they're doing to defend against today's threats. Download the report to see what they're saying.
Register for InformationWeek Newsletters
White Papers
Current Issue
2017 State of IT Report
In today's technology-driven world, "innovation" has become a basic expectation. IT leaders are tasked with making technical magic, improving customer experience, and boosting the bottom line -- yet often without any increase to the IT budget. How are organizations striking the balance between new initiatives and cost control? Download our report to learn about the biggest challenges and how savvy IT executives are overcoming them.
Twitter Feed
Sponsored Live Streaming Video
Everything You've Been Told About Mobility Is Wrong
Attend this video symposium with Sean Wisdom, Global Director of Mobility Solutions, and learn about how you can harness powerful new products to mobilize your business potential.
Flash Poll