FDA hopes a new guidance will provide a “more efficient approach” to making sure that safe and effective medical devices reach patients more quickly. Broadly speaking, industry generally supports the new guidance, while consumer advocates are wary.
In a nutshell, FDA has modified its 510(k) Refuse to Accept (RTA) policy to include an early review against specific acceptance criteria and to inform the submitter within the first 15 calendar days after receipt of the submission if the submission is administratively complete, or if not, to identify the missing element(s).
So far, so good.
In order to enhance the consistency of acceptance decisions and to help submitters better understand the types of information FDA needs to conduct a substantive review, the agency says the guidance, including the checklists included in its appendix, clarify the necessary elements and contents of a complete 510(k) submission. The process is applicable to all devices reviewed through the 510(k) notification process and has been compiled into checklists for use by FDA review staff.
“It is critical to distinguish between the completeness of the regulatory submission, and the quality of the data provided and any studies conducted in support of the submission,” FDA says in the guidance. FDA’s assessment of the completeness of the 510(k) occurs during the acceptance review, while the assessment of the quality of the submitted information occurs during the substantive review. FDA will now base acceptance on the objective criteria outlined in the associated Acceptance Checklist, rather than the quality of the data.”
The medical device industry generally applauded the intention and basic guidance scope. However, some had concerns with specific criteria.
As Abbott states in its comment, “Although many of the elements are written in an objective manner to facilitate an administrative review, there are other elements of the checklists which, as written, are more subjective and begin to cross into a substantive review.”
AdvaMed, the medical device industry trade group, echoes that general spirit in its comment.
Writing, it ” believes the MDUFA III agreement will improve FDA review of medical devices, ensuring that American patients have timely access to safe and effective medical technologies.” However, “to be effective, an improved process must rely on objective checklist criteria, clarify who is responsible for each task in the process, and encourage prompt and clear communication between the Agency and industry throughout the process.”
Finally, FDA encourages all submitters to provide an electronic copy (eCopy) in place of one of the two hard copies of the 510(k) submission. FDA has issued guidance to implement Section 745A(b) of the FD&C Act, added by Section 1136 of FDASIA, which provides statutory authority to require an eCopy for most submissions, including 510(k) submissions and amendments. With the implementation of this provision a valid eCopy will be required in order for a 510(k) to be processed and for the acceptance review to begin.