FDA moves to single electronic filings for device submissions
The FDA is proposing to allow medical device companies to file for regulatory clearances through a single electronic submission.
Adoption of the proposal would free companies from the need to submit paper forms and multiple electronic copies when seeking 510(k) clearances and other regulatory green lights.
FDA expects the new system to generate savings of around $3 million a year if it comes into force.
FDA's rules on medical device submissions predate the powers to mandate electronic filings that it gained through the Federal Food, Drug, and Cosmetic Act. Through subsequent laws and guidance documents, FDA eliminated the need for device manufacturers to submit multiple paper copies when applying for regulatory clearance.
However, manufacturers still needed to file one copy on paper and comply with multiple copies rules. The only difference following FDA's changes was that copies could be filed electronically.
This compromise, which seeks to minimize burdens while complying with the multiple copy rule, has been in place for several years. The push to create a better system was given a boost last year when FDA Reauthorization Act of 2017 required filings to be submitted solely in electronic formats. Following that change and the publication of executive orders on regulatory reform, FDA thinks it has the mandate and authority to drop the current compromise in favor of single electronic filings.
"Because a medical device premarket submission in electronic format is easily reproducible, and the requirement for multiple copies, whether in electronic format or paper form, is no longer necessary, FDA believes it is beneficial to the public to limit any burden and expense to submitters caused by requiring additional copies," the FDA wrote in a notice about the planned changes.
The changes will affect 510(k) submissions, premarket approval (PMA) filings, investigational device exemption applications and humanitarian device exemption applications. In total, the FDA thinks moving all these regulatory processes over to the single electronic filing system will generate savings of close to $3 million a year. The FDA expects the costs of the new system to be minimal.
Officials are accepting feedback on the planned changes until December 12.