The Food and Drug Administration issued a final rule this month to require electronic submission of medical device premarket applications, shifting away from the previous paper-based filing process.
The move to digital filings is expected to increase transparency by making an electronic version of a medical device premarket application immediately available for review, while cutting down on paperwork.
“This action would reduce the number of copies in electronic format required, thus improving and making more efficient the FDA's premarket submission program for medical devices,” the agency noted in the Federal Register, where the rule was published.
The rule became effective on January 15, 2020. It comes as critics have blasted the agency for relying on device-makers to voluntarily report adverse events, taking too long to pull harmful devices from the market and fast-tracking approvals of new drugs, as Becker’s Hospital Review reported.
Researchers from Harvard Business School found the agency routinely fast-tracked approvals of drugs reviewed at year-end and that those drugs were linked to twice the number of adverse event reports, including hospitalizations and deaths.
The final rule applies to the following device applications:
- 510(k) premarket notification
- Premarket approval application (PMA)
- PMA supplement
- Confidentiality of information certification
- Investigational device exemption (IDE) application
- Humanitarian device exemption (HDE) application
PMA is the FDA’s most stringent review process, requiring drugs and devices to clear a scientific and regulatory review. In contrast, the 510(k) premarket notification is a controversial accelerated process where device-makers may gain marketing approval by showing that a "substantially equivalent" device is already being used in patients.
The agency received just 14 comments on the proposed rule during the review period, per the Federal Register. The majority of commenters voiced support, saying that electronic records might reduce errors, increase efficiency, promote innovation and speed up accessibility for patient care.
The FDA expects the shift to digital filings might generate $1.76 million in annualized benefits over the next decade.