By Rebecca Mayo, J.D.
A new final rule amended requirements for medical device premarket submissions to remove paper and multiple copies and replace them with a single electronic submission.
As part of its ongoing efforts to update and replace outdated regulations, the FDA has issued a new final rule eliminating the need for paper and multiple copies in medical device premarket submissions. According to the FDA, the final rule should 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. Further, the rule will benefit the public by limiting any burdens and expenses to submitters caused by requiring additional copies (Final rule, 84 FR 68334, December 16, 2019).
Goals. Since the Executive Order "Enforcing the Regulatory Reform Agenda" was issued, the FDA has been updating its regulations. Current medical device regulations that require multiple copies and paper submissions predate the authority provided the FDA to require submissions in electronic format. Even once that authority was granted, the FDA was required to take a step-wise process of first issuing guidance with the standards and criteria for submitting eCopies. The eCopy guidance issued by the FDA did not change the overall number of copies required for any submission. It merely allowed eCopies to be provided in lieu of some of the paper copies, although not all of the paper copies.
The FDA believes that this 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. The final rule will result in annualized benefits of $1.76 million at a three percent discount rate and $1.76 million at a seven percent discount rate over 10 years. It will also result in annualized costs of $0.75 million at a three percent discount rate and $0.87 million at a seven percent discount rate over 10 years.
Major provisions. The final rule amends regulations for medical device premarket submissions that require paper and multiple copies, to require only a single submission in electronic format. Submissions in electronic format include eCopies, submissions created and submitted on CD, DVD, or flash drive and mailed to FDA, and eSubmissions, submission packages produced by an electronic submission template. Additionally, the regulations that identify FDA’s mailing addresses for submissions will be amended to replace those addresses with website addresses for Center for Devices and Radiological Health and Center for Biologics Evaluation and Research that provide the current mailing addresses.
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