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Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Required in Electronic Format (Final Rule) Regulatory Impact Analysis

FDA is issuing this final rule to amend device regulations describing the number of copies firms must submit with a premarket pre-submission or submission. The final rule will also amend all device regulations containing a reference to the specific form of a submission to require a submission in electronic format.

The final rule will produce cost-savings for firms without imposing any additional regulatory burdens for submissions or affecting the Agency’s ability to review submissions. We estimate that the final rule will result in annualized benefits of $1.76 million at a 3 percent discount rate and $1.76 million at a 7 percent discount rate, over 10 years. Firms will incur minimal administrative costs to read and understand the rule. We estimate that the final rule will result in annualized costs of $0.75 million at a 3 percent discount rate and $0.87 million at a 7 percent discount rate, over 10 years.

The final rule will not amend regulations regarding submission types for which submissions in electronic format are voluntary, including compassionate use IDEs, Emergency Use IDEs, Emergency Use Authorizations, Device Master Files, and Requests for Information. The rule will also not change the eCopy requirements for Biologics License Applications and Investigational New Drug Applications.

Regulatory Impact Analysis

Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Required in Electronic Format (Final Rule) (PDF – 246.7KB)

Federal Register: 84 FR 68334-68340, December 13, 2019

Docket: FDA-2018-N-0628