Six preliminary FDA refuse-to-accept screening questions any 510(k) submission must pass

By Stewart Eisenhart, Emergo Group

Now that the US Food and Drug Administration has updated its Refuse to Accept (RTA) policy for 510(k) submissions, it’s important to review some key aspects of the policy that can determine whether a medical device manufacturer’s application may move on to substantive review.

Before your traditional or abbreviated 510(k) submission undergoes a more thorough checklist review for completeness under the RTA policy, your application must meet six preliminary qualifications in order to initiate RTA and then substantive evaluation. All 510(k) applicants should familiarize themselves with these requirements, and ensure to the best of their ability that their applications meet these requirements.

1.Is the device or a component of the device subject to 510(k) review? If the device or the device component of a combination product does not appear to fall under 510(k) premarket notification requirements, reviewers will consult with jurisdictional officers in the Center for Devices and Radiological Health (CDRH) or Center for Biologics Evaluation and Research (CBER) to determine whether to continue or halt the RTA evaluation.

2.Was the device submitted to the appropriate center? RTA reviewers must determine whether a 510(k) application was submitted to the correct Center (CDRH or CBER); in cases where applications are submitted to the incorrect Center, reviews are halted and applicants are notified.

3.Has a Request for Designation (RFD) for a device been submitted and assigned to the CDRH or CBER? If so, is the device the same one presented in the RFD submission? Are indications for use in the 510(k) submission the same as those in the RFD submission? Any modifications to a device or its indications for use occurring after its RFD determination but before its RTA review may require reevaluation before completeness and substantive reviews may continue.

4.Is the device type eligible for 510(k) submission? Is the device under acceptance review appropriate for the 510(k) registration pathway? If not, the review is stopped and the submitter notified.

5.Is the same device with the same indications for use also undergoing PMA?In cases where the applicant has submitted the same device with the same indications for use for both 510(k) acceptance review and Premarket Approval (PMA) review, acceptance review will be halted until the proper registration pathway for the device is determined.

6.In cases where clinical studies have been submitted, is the applicant subject to the Application Integrity Policy? If an applicant’s submission includes clinical data and that applicant has been included in the FDA’s Application Integrity Policy list, that means the applicant’s substantive scientific review has been deferred, or that any already approved applications are being withdrawn.  Reviewers will then consult with other CDRH and/or CBER staff to determine whether acceptance review should continue or stop.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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