Dental Tribune America

FDA issues amendment for medical device submissions

By Dental Tribune International
December 20, 2019

SILVER SPRING, Md., U.S.: As dental workflows continue to become increasingly digitally based, so, too, do certain regulatory processes. The U.S. Food and Drug Administration (FDA) has recently finalized a rule that removes requirements for multiple paper copies as part of the medical device submission process, instead replacing these with a single electronic submission.

According to the FDA, the regulation is, in part, a response to a 2017 Executive Order issued by President Donald Trump, which requires American government agencies to eliminate two regulations for each new regulation installed.

“FDA is amending current medical device regulations that require multiple copies and papdenter submissions to improve the efficiency of the review process by allowing immediate availability of an electronic version for review, rather than relying solely on the paper version,” the agency stated in a document outlining the changes.

“Because a submission in electronic format is easily reproducible, the requirement for multiple copies (whether in electronic format or paper form) is no longer necessary,” it continued.

To clear a medical device for commercial use in America, the manufacturer is required to submit a premarket notification 510(k) to the FDA with the goal of demonstrating that it is at least as safe and effective as a similar medical device that is already available for purchase. According to the FDA’s Medical Device Database, 227 dental devices have been granted clearance thus far in 2019.

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