- February 15, 2020
The Agency said the rule, proposed in September 2018 and will take effect in 30 days, is in response to an executive order from the Trump Administration in 2017 made famous as the “one-in, two-out” order. FDA’s rule is meant to improve the device premarket submission program and create a more efficient submission system. “The requirement for a single submission in electronic format applies to all submission types that fall within the provisions listed in section 745A(b) of the FD&C Act; under this final rule, FDA is only amending those regulations that specifically mention paper and/or multiple copies of such regulatory submissions and are not consistent with this final rule,” FDA said.
The Agency responded to four comments on the proposal but did not update the rulemaking. The Agency noted that the final rule will produce cost savings for firms without imposing any additional regulatory burdens for submissions or affect the Agency’s ability to review submissions. “Firms will 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,” FDA said.
The Agency also noted that submissions in electronic format can include those created and submitted on CD, DVD or flash drive and mailed to FDA. For premarket approval applications (PMAs), the final rule changes one section to take out a section requiring an applicant to submit three copies of any updated safety and effectiveness report for pending applications. FDA also previously required that PMAs be submitted in six copies, each bound in one or more numbered volumes; however, that language has been removed with this final rule.
In another section, FDA removes the requirement that a PMA applicant has to provide copies of information that it believes to be trade secret or confidential commercial or financial information in the PMA. FDA in September 2019 also published a draft guidance with “both binding and nonbinding provisions” related to electronic submissions for medical devices.
REFERENCE: RAPS – Regulatory Focus; 13 DEC 2019; Zachary Brennan