FDA proposes medical device rule to simplify classification process

26 March 2014

The US Food and Drug Administration (FDA) is proposing to amend its regulations governing classification and reclassification of medical devices to conform to provisions in the FDA Safety and Innovation Act (FDASIA).

Published in the Federal Register, the proposed rule would simplify the classification process as the US Congress directed in the 2012 FDASIA legislation, reports Health Data Management.

"FDA is proposing these revisions to update its regulations to reflect these and other changes, and to ensure classification of devices in the lowest regulatory class consistent with the protection of the public health and the statutory scheme for device regulation," states the proposed rule.

Congress passed FDASIA to change the procedures for reclassification of devices under the Federal Food, Drug and Cosmetic Act, and to reduce some of the bureaucratic red tape associated with the classification process. By shifting from notice and comment rulemaking to an administrative order process, supporters of the proposed rule say there are "fewer hoops" for the FDA to jump through in order to classify a new technology.

"This proposed rule is a very long anticipated and much needed improvement in the classification and reclassification process," said Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition. "The classification process acts as a sort of gateway to FDA regulation, dictating for a specific, defined category of medical device the regulatory requirements that apply.

"FDA is supposed to develop classifications for each new type of medical technology so the public knows the associated regulatory requirements. Unfortunately, FDA has fallen behind in developing new classification regulations because creating the classifications takes so darn long and involves an almost endless number of legal hoops the agency has to jump through."

One area of health information technology that stands to potentially benefit from the proposed FDA rule is mobile healthcare, according to Thompson.

"Mobile health hardware and app development has led to a tidal wave of new products that do not fit squarely into the old classification system," he said. "As a result, unfortunately due to the lack of new classification regulations defining the new categories and the associated regulatory pathways, mHealth innovation has been frustrated. mHealth innovators don't know the classifications for the new technology and the associated regulatory requirements, so they can't navigate the FDA system because they don't have the roadmap.

"It's our hope that by streamlining the classification process and getting rid of some of the needless bureaucratic obstacles, FDA can do a better job of keeping up with these important new technologies, providing clear guidance for the new categories of technology being developed," he added.

The public comment period for the proposed rule ends on 23 June.



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