The CDRH clarified its policy on the criteria it intends to use in assessing whether a 510(k) or premarket approval submission will be accepted for review.
The agency’s current Refuse to Accept policies for 510(k)s and PMAs include an early review against specific acceptance criteria with the goal of informing the applicant within 15 days if submissions are deemed complete and, if not, to identify the missing elements in the submissions, according to final guidances that supersede guidances the agency issued on Jan. 30, 2018.
Both the guidance includes checklists and clarify the necessary elements that devicemakers should include in a complete 510(k) and PMA submission.
The process is applicable to all devices reviewed through the 510(k) notification process, the FDA said, including its new abbreviated 510(k) review process, which was renamed the Safety and Performance Based Pathway.
The 510(k) refuse to accept (RTA) policy is separated into two stages, quantity vs. quality. The first stage, acceptance review, allows the FDA’s review staff to determine whether the submission is complete before conducting a substantive review in which the actual quality of the data is assessed.
Past guidances on the policy focused on defining broad issues or principles, and the checklists “dealt largely with administrative elements but did not address specific content that is essential for 510(k) review,” which in turn led to an “inefficient use of resources and frequently lengthened review times,” the agency said.
An initial review of completeness enables early interactions as the submitters can be informed of missing elements in a 510(k) deemed incomplete within 15 days after the agency receives the submission.
The checklist in the final guidance includes new statements of compliance for clinical investigations to include updated rules for good clinical practice (GCP) device compliance that became effective Feb. 21.
For example, for each clinical trial conducted in the U.S., the submission should include a statement of GCP compliance or a brief statement of the reason for noncompliance.
Similarly, for each trial conducted outside the U.S., the submission should either include a statement that the investigations were conducted in accordance with GCP requirements or a waiver request. Alternatively, the submission would include a brief statement of the reason for not conducting the investigation in accordance with GCP and a description of steps taken to ensure that the data and results are credible and accurate and that the rights, safety, and well-being of subjects have been adequately protected.
The new checklist also includes statements on whether the device uses FDA-recognized voluntary consensus standards or non-FDA recognized consensus standards.
Like the 510(k) guidance, the updated PMA guidance includes new sections that include statements of GCP compliance for clinical investigations. It also adds a section on whether the device uses FDA-recognized voluntary consensus standards or non-FDA recognized consensus standards. Otherwise, the guidance is the same as earlier guidance issued in January 2018.
The FDA has been revamping its 510(k) program over the last year. It recently issued guidance on an expanded abbreviated 510(k) clearance program that would allow companies to show a new product’s substantial equivalence to an existing device using performance criteria rather than directly comparing the device’s performance to a predicate device.
The agency said the new pathway should be less burdensome than the longstanding abbreviated 510(k) route to market. The new pathway provides increased certainty regarding the likelihood of clearance for qualifying devices that should mean a shorter time to 510(k) clearance (IDDM, Feb. 1).
Read the final 510(k) guidance here: www.fdanews.com/02-28-19-510kguidance.pdf.
Read the final PMA guidance here: www.fdanews.com/02-28-19-PMAguidance.pdf.