The proposed rule, if finalized, would clarify the De Novo classification process and the requirements for De Novo requests for certain medical devices to obtain marketing authorization as class I or class II devices. Although we don’t quantify the potential cost savings from this rule, we expect that the rule would reduce the likelihood that medical device manufacturers submit inappropriate 510(k) requests for their De Novo devices and improve the quality of De Novo requests. Better quality De Novo requests could save medical device manufacturers unnecessary costs and reduce our review times. Over 10 years with both a 3 percent and 7 percent discount rate, the present value of the costs range from $0.00 million to $1.13 million; annualized costs range from $0.00 million to $0.08 with a 7 percent discount rate and range from $0.00 million to $0.03 million with a 3 percent discount rate.

Regulatory Impact Analysis

Medical Device De Novo Classification Process (Proposed Rule) PRIA (PDF-271KB)

Federal Register: 83 FR 63127, December 7, 2018

Docket: FDA-2018-N-0236