The FDA’s updated Refuse to Accept (RTA) policy for 510(k) applications that lack required documentation is now in effect. The draft version was issued last summer.
This new policy outlines an early review process for 510(k) applications to determine whether they contain all the required materials for starting a substantive review.
FDA officials are hopeful this revised process will improve the efficiency of the premarket notification review that determines 510(k) clearance for a device. By identifying incomplete applications and sending them back to the submittors earlier in the 510(k) process, the FDA hopes to free up more time to spend on submissions that have been submitted correctly. The early review is for administrative purposes only; no data is evaluated.
Checklists Smooth the Process
The RTA policy provides checklists for traditional, abbreviated, and special 510(k)s.
“The checklists include five preliminary questions to be answered before the content of the 510(k) is compared to the acceptance criteria,” state Hae Park-Suk and Lynne C. Tyler of Barnes and Thornburg. “Is the product a device or a combination product with a device component? Is the application with the appropriate center (CDRH or CBER)? Is 510(k) the appropriate regulatory submission? Is there a pending pre-market approval application for the same device and indications for use? And, if clinical studies have been submitted, is the submitter the subject of the application integrity policy?”
Upon submission of a 510(k) application, the FDA has 15 days to decide whether the application is complete. If the FDA rejects the submission, the submittor is notified and receives a copy of the checklist so it can provide the missing information. The applicant has 180 days to respond to the RTA notice; if there is no response within that timeframe, the FDA will consider the 510(k) to be withdrawn.
After the requested information is provided by the submittor, the FDA has 15 days to complete the screening. This process can be repeated multiple times until a complete submittal is received and approved by the FDA; the submittal is also considered approved if the FDA does not respond in 15 days.
Missing information should be included in the file under the applicant’s original 510(k) number. A new submission and user fee are not required when resubmitting after a RTA notice.
Quick & Painless
This policy is a relatively painless step that should help medical device manufacturers get their products to market more quickly by creating efficiencies early in the submittal process.
Ultimately the FDA hopes the new guidance “will clarify the content needed in traditional, special, and abbreviated 510(k) submissions to allow FDA to conduct a substantive review, thereby enhancing the quality of received 510(k) submissions and improving overall review time.”