The FDA issued revised guidance documents earlier this year clarifying the agency’s ‘Refuse to Accept’ policy for 510(k)s and PMAs. The updated policy raises questions for companies developing and submitting combination products for regulatory approval, according to lawyers Allyson Mullen and Rachael Hunt.
The associate partners detailed changes to the components that companies must include in a 510(k) or PMA in order for the FDA to accept it for review. The updated list of requirements now includes a mandate for companies to identify whether or not their proposed offering is a combination drug-device product.
The FDA suggested last week in a webinar, according to Mullen and Hunt, that it will decide whether an applicant has correctly identified its product as a combination product.
“This question seems fraught with potential complications,” the lawyers wrote.
It’s not always obvious when a device should be counted as a combination product. Under conventional guidance, if the Center for Devices and Radiological Health identifies a product that may be a combination product instead of just a device, the agency recommends that the applicant ask the Office of Combination Products if a 510(k) pathway is appropriate.
“Under the revised RTA, if there is a debate as to whether a product is a combination product or strictly a device and a sponsor answers ‘incorrectly,’ from FDA’s perspective, it is possible that the agency could RTA the submission,” Mullen and Hunt wrote.
“Unlike our experience with the prior RTA checklist, the new question could prevent the submission from being filed, even if the response does not affect whether or not the product would proceed through the 510(k) pathway. During the webinar, FDA did not specifically mention the need for increased interaction with OCP prior to filing of 510(k)s or PMAs. This new question, however, certainly opens the door for CDRH to force more applicants to seek a definitive determination as to a product’s status from OCP prior to accepting a submission for review,” they added.