A new draft guidance document published by the US Food and Drug Administration (FDA) establishes the criteria under which the agency can refuse to accept a 510(k) substantial equivalence application submitted to the agency.
510(k) applications are used to approve devices which are based upon and otherwise substantially equivalent to medical devices approved by FDA. Under the 510(k) process, devices are cleared-not approved-by the agency if they can show substantial equivalence, and are mostly exempt from submitting clinical trials data in support of the application.
Consolidated Pre-review Process
The new draft guidance, Refuse to Accept (RTA) Policy for 510(k)s, puts into place a consolidated initial review process for 510(k) applications before they are deemed to be administratively complete and passed on to a full review staff at FDA.
An initial review of an incoming 510(k) application will first be conducted to determine if it meets acceptance criteria established by the agency. FDA said it will make this determination and inform the sponsor of its status within 15 days of receiving the application. If an application is not complete, FDA will identify the missing elements and communicate them to the sponsor.
FDA said the new draft guidance is set to combine and replace two earlier draft guidance documents: CDRH's Premarket Notification Refuse to Accept (RTA) Policy and 510(k) Refuse to Accept Procedures, 510(k) Memorandum K94-1. Both guidance documents have been in effect since before 1995. These guidance documents used broad issues and had general checklists, FDA said.
"As a result, FDA accepts many inadequate submissions for review and FDA staff invests significant time in constructing extensive letters requesting all of the additional information needed to conduct a substantive review," the agency said. "This approach is an inefficient use of resources and frequently lengthens review times."
"In order to enhance the consistency of our acceptance decisions and to help submitters better understand the types of information FDA needs to conduct a substantive review, this guidance, including the checklists included in the appendices, clarifies the necessary elements and contents of a complete 510(k) submission," explained FDA.
Checklists for Traditional, Special and Abbreviated 510(k) Applications
FDA notes the preliminary acceptance review will not include an assessment of the substance of the report, but simply assess whether all necessary parts are present. Sponsors may also communicate to the agency any alternative approaches taken on their application and why FDA should overlook the omission of a particular item, if warranted.
The review is also divided into two parts: a preliminary assessment of the basics of the application and a thorough acceptance review. The preliminary assessment asks whether the medical device is defined appropriately, whether it has been submitted to the appropriate center for review, if the application should instead be utilizing an alternate application type, if a Premarket Application (PMA) is pending for the same device and if the company submitting the 510(k) is subject to any additional restrictions such as an Application Integrity Policy.
FDA's more thorough pre-acceptance review for 510(k) applications involves one of several checklists for regular 510(k) applications, abbreviated 510(k) applications, and special 510(k) applications. FDA notes if a company incorrectly submits a special 510(k) application when FDA determined a traditional 510(k) is required, the agency will notify the company of the switch and assess the application using the appropriate checklist.
FDA's checklists are extensive, with traditional and abbreviated 510(k) RTA checklists encompassing 37 questions in 11 different categories, and the special 510(k) RTA encompassing 21 questions in five different categories.
The guidance comes just days after a related policy was released by FDA pertaining to its PMA application rejection policies, which were tweaked to allow the agency to reject incomplete applications even faster.
Under the new Acceptance and Filing Review for Premarket Approval Applications, FDA will utilize a two-part approach not unlike its 510(k) process. Review staff will first assess whether a PMA filing is complete based on the presence of all administrative elements before looking at the consistency of data in the application relative to the proposed protocol, final device design, proposed indications and other considerations.