FDA Issues New Refuse to Accept Policy for 510(k)sAugust 13, 2012
On August 10, 2012, FDA issued a draft guidance, “Refuse to Accept Policy for 510(k)s.” This draft guidance largely mirrors the recently issued draft guidance for premarket approval applications, “Acceptance and Filing Review for Premarket Approval Applications (PMAs),” on which we previously commented here.
The draft guidance includes checklists for traditional, abbreviated, and special 510(k)s, based largely on the regulatory requirements for 510(k)s outlined in 21 C.F.R. § 807.87. Included in the checklist are elements that will not necessarily be applicable to all devices, e.g., biocompatibility testing. If a submitter believes that a particular element is not relevant to the submission, it should provide a justification for not including the information.
Within 15 days of receipt of the submission, FDA must inform the submitter if the submission is administratively complete, or, if not, identify the missing elements. The submitter may then respond by providing the missing information, and FDA will then have another 15 days to perform the acceptance review. The submitter should provide the information under the originally assigned 510(k) number. FDA will not require a complete new submission, nor will the submitter be required to pay a new user fee upon providing the missing information.
The guidance states that if FDA fails to complete the acceptance review within 15 days, the submission should be considered accepted, but “FDA may ask for any information during the substantive review that may have been unintentionally overlooked during the acceptance review.” The review clock for MDUFA goal purposes will not begin until FDA determines that the submission is administratively complete. This review does not assess whether the contents of the application are substantively sufficient to make a substantial equivalence determination.
The guidance contains certain principles that it suggests reviewer and submitters should heed in determining whether a 510(k) submission is complete: 1) acceptance should not be based on a substantive review of the submission; 2) reviewers should consider any justifications provided by the submitter as to why certain elements are not included, and; 3) submitters should review any applicable guidance or standards to ensure the submission contains all necessary information for that device type.
The guidance provides preliminary questions to be addressed by the reviewer prior to determining whether the submission contains all elements in the checklist. These questions include: (1) Is the product a device? (2) Is the submission within the correct center (e.g., CDRH or CBER)? (3) Is a 510(k) is the appropriate regulatory submission? (4) Is there a pending PMA for the same device with the same indications? (5) If clinical data are submitted, is the submitter subject to the Application Integrity Policy (AIP)? Though most of these questions could be easily answered during a preliminary review, determining whether the 510(k) path is appropriate could require a more substantive review, and may not always easily be determined. For some products, it also may not be as clear as to whether the product is a device (see, e.g., here). If a submitter is unsure of the appropriate regulatory path prior to providing a submission to FDA, it should consider submitting a 513(g) to determine FDA’s likely regulatory approach.