FDA may change how it announces PMA, HDE decisions
- FDA has taken a step toward ending its practice of publishing a list of approvals and denials of premarket approval applications and humanitarian device exemption applications each quarter in the Federal Register.
- In a new proposed rule, the agency said it wants to amend the medical device regulations covering the process of making those announcements. It would still post such decisions on its website home page and make summaries of PMA safety and effectiveness data (SSED) and HDE safety and probable benefit (SSPB) information available on the Internet.
- Copies of PMA application approvals and denials, as well as SSED documents, also would continue to be available upon written request, through the agency’s Freedom of Information staff.
FDA continues to identify ways to streamline procedures and eliminate duplication as part of a broader push for greater operational efficiency. Last week, the agency issued a final rule to reduce paper submissions in its premarket application process and move to a single electronic filing per review request.
The proposed change to how PMA and HDE approvals and denials are announced was among the top priorities named on the agency’s end-of-year regulatory to-do list announced last month. The plan would free up FDA staff to focus on other priorities, the agency said. Cost savings were estimated at $10,000 on an annualized basis over 10 years.
The public would continue to receive notice of PMA and HDE approvals and denials, and interested persons could still request a review of an FDA action for up to 30 days after the notice is displayed on the internet. Requests for copies would be sent to the Freedom of Information Act staff, which currently handles them, rather than the division of dockets management. For purposes of clarity and accuracy, the agency also expects to update its contact information as well as outdated statutory references in PMA and HDE regulations.
FDA discontinued publication of individual PMA approvals and denials in the Federal Register in a 1998 final rule, noting at the time that announcements placed on the internet reach the public more quickly and are accessible to more people than those published in the Federal Register.
The agency is seeking comments on the new proposed rule over the next 75 days.