The US Food and Drug Administration (FDA) Centre for Devices and Radiological Health (CDRH) has updated guidance documents on its policies for refusing to accept 510(k)s and refusing to accept and file reviews for premarket approval applications (PMAs).
The PMA regulation identifies criteria that, if not met, may result in a refusal to file a PMA. Thus this updated guidance is tailored for the device industry and FDA staff to help shed light on the broad preclinical and clinical issues that need to be addressed in a PMA and the vital decisions to be made during the filing process.
The purpose of the updated guidance regarding the refusal to accept policy for 510(k)s is to explain the procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review.
The PMA guidance has replaced previous guidance from 31st December 2012, while the 510(k) guidance replaces one with the same name from 4th August 2015. The guidance documents contain useful checklists to identify the required elements and contents of a complete application.
The FDA CDRH has modified the PMA filing guidance and checklist, separating the criteria for PMA filing into acceptance criteria and filing criteria. However it should be noted that the guidance is not significantly different from the previous PMA filing checklist and guidance document, as PMA filing criteria defined in the Regulation have not changed.
The “preliminary questions” remain the same and the “filing review questions” have been separated into “acceptance decision questions” (i.e., whether the file is administratively complete) and “filing decision questions” (i.e., whether the data are consistent with the protocol, final device design, and proposed indications)
The purpose of the PMA acceptance and filing reviews is to make a threshold determination about whether an application is administratively complete for the Agency to undertake a substantive review.
Furthermore, the updates address provisions in the 21st Century Cures Act from 2016, as that law amended section 503(g) of the Food, Drug and Cosmetic Act (FD&C Act) and applies certain drug provisions to device-led combination products.
Submitters seeking action on a combination product must identify the product as such, under the amended section.
As per the amended section 503(g)(5), submissions for device-led, device-drug combination products must include the patient certification or statement as stated in section 505(b)(2) and provide notice as described in section 505(b)(3) if the combination product contains as a constituent part of an approved drug.
The FDA states that “if information regarding drug exclusivity or patents as outlined in these guidance documents is not included in a premarket submission received by FDA before or up to 60 days after publication, FDA intends to request such information during the review of the submission, as necessary.”
To read the updated guidance on acceptance and filing reviews for PMA’s, please click here.
To read the updated guidance on refusal to accept policy for 510(k)s, please click here.