The proposed rule would amend device regulations requiring the number of copies firms must submit with a premarket pre-submission or submission. The proposed rule would also amend all device regulations containing a reference to the specific form of a submission to require an electronic submission. The amendment would produce cost savings for firms without imposing any additional regulatory burdens for submissions or affecting the Agency’s ability to review submissions. Firms would incur minimal administrative costs to read and understand the rule. We expect the economic impact of this regulation to be a total net costs savings yielding positive net benefits.
Regulatory Impact Analysis
Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Allowed in Electronic Format (Proposed Rule) Regulatory Impact Analysis (PDF – 157KB)
Federal Register: 83 FR 46444, September 13, 2018