ARTICLE SUMMARY:
FDA drafts guidance on 510(k) predicates, clinical data, and implants. Excerpted from Pathways’ Picks September 6: 510(k) Guides, TAP Partners, and Digital Health.
FDA published three draft guidance documents September 6 that the agency says will support efforts “to strengthen and modernize the 510(k) program.” The guides address “best practices” for selecting a predicate device, factors for determining when clinical data is needed for a 510(k), and specific 510(k) evidence expectations for implantable devices. The documents compile advice from existing 510(k) program guidances, and also add some new details and emphasis on considerations that the agency says are important to “advance the safety and effectiveness of medical devices as they become more complex and innovative.” Public comments on the draft guidances are due December 6.
One FDA priority that comes through loud and clear on first reading of the drafts: companies need to pay close attention not only to technical comparisons between their device and predicate devices but also to the postmarket safety of predicates. Choosing a predicate device is a core part of the traditional 510(k) process, but it has generated controversy, for instance, in studies pointing out the prevalence of devices cleared based on predicates that have been subject to serious postmarket safety alerts and recalls. The “best practices” draft guidance underscores these concerns as a central factor when a company is picking a predicate, urging manufacturers to try to avoid devices that have been linked to clear safety concerns based on adverse event and recalls data. In addition, the 510(k) clinical data draft guidance newly emphasizes postmarket safety concerns linked to a predicate as a key factor for determining whether a 510(k) will require a clinical study. “There may be an awareness of new scientific information regarding a newly identified or increased risk of the predicate device, and clinical data may be needed to determine [substantial equivalence] in light of the new scientific information,” the guidance states.