- FDA issued a final rule Friday that takes paper out of the medical device premarket application process, instead requiring a single electronic filing to make the program more efficient.
- The agency estimates the rule, published in the Federal Register, will produce $1.76 million in annualized benefits over 10 years.
- In conjunction, FDA updated a 2013 guidance document to clarify processing and technical standards for electronic copies (eCopies) for medical device submissions.
The shift away from paper filings is expected to streamline the review process by making an electronic version of a medical device premarket application immediately available for review. The rule also reduces the number of copies required in electronic format, simplifying requirements and lowering expenses for submitters.
Applications in electronic format include eCopies, submissions created on CD, DVD or flash drive and mailed to FDA, and packages produced using an electronic submission template. Multiple copies are no longer required in any format because an electronic form is easily reproducible.
The final rule applies to 510(k) premarket notifications, confidentiality of information certifications, investigational device exemption (IDE) applications, premarket approval applications (PMAs), PMA supplements and humanitarian device exemption (HDE) applications.
Sections of submission regulations that provide FDA's mailing address will be amended with a website address for either the Center for Devices and Radiological Health or Center for Biologics Evaluation and Research.
FDA said comments it received when the rule was initially proposed were all supportive, with the rule expected to speed the premarket application process, lower costs, reduce errors and free up storage space.
The rule becomes effective 30 days after publication in the Federal Register.
FDA said it is updating the following guidance documents to comply with the new final rule:
- Acceptance and Filing Reviews for Premarket Approval Applications (PMAs).
- Real-Time Premarket Approval Application (PMA) Supplements.
- 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75- Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes.
- Annual Reports for Approved Premarket Approval Applications (PMA).
- FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act.