With an eye toward encouraging quality applications for review, the FDA has provided an update on what information it needs from sponsors to determine whether a 510(k) submission meets a minimum threshold and thus may be accepted for substantive review.
Issued Aug. 4, the new FDA guidance updates a 2012 document and is intended to explain the refuse-to-accept policy for 510(k)s. As part this policy, the FDA reviews an application and within 15 calendar days should inform the company whether the submission is administratively complete or if additional elements are needed.
“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, clarify the necessary elements and contents of a complete 510(k) submission,” according to the document.
As part of the update, the agency has added guidance documents and other resources that industry may use when preparing regulatory submissions. It also has streamlined the checklists in the appendices covering traditional, abbreviated and special 510(k)s.
Some sections have been either eliminated or incorporated in other parts of the list. One change is the elimination of a section requesting companies include a form for each national or international standard referred to in the application to demonstrate substantial equivalence for traditional 510(k)s. That checklist adds to the section on sterilization, which now includes options for devices not requiring a sterility status, such as, software-only devices, and for those products whose sterility status is unclear.
The guidance, which goes into effect Oct. 1, will supersede three previous documents: 2012’s “Food and Drug Administration’s Refuse to Accept Policy for 510(k)s,” 1993’s “Premarket Notification (510(k)) Refuse to Accept Policy” and 1994’s “510(k) Refuse to Accept Procedures (K94-1) blue book memo.”