The Food and Drug Administration has issued a final rule it says will provide a "less burdensome path to market" for certain software and hardware products that are used with medical devices.
These products, known as medical device data systems, are used to display, transfer or store medical device data. One example, according to an FDA news release, is the device that collects and stores data from a glucose meter.
In the final rule, the FDA classified medical device data systems as Class I or low-risk devices, a move that will make them exempt from premarket review while still ensuring that they adhere to quality standards. The agency had previously categorized these products as Class III, meaning they required premarket approval.
"This shows our flexibility in applying regulations for medical device data systems that are not overly burdensome for manufacturers but continue to assure that data stored, transferred or displayed on these systems remain reliable," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in the release.
The new rule comes on the heels of a Feb. 8 announcement by the FDA that it would work to speed the review process for breakthrough medical devices through its Innovation Pathway program.