On November 26, 2018, FDA published an outline of the numerous improvements to the 510(k) program. These updates, which date as far back as 2009, have strengthened the 510(k) process by providing both applicants and reviewers with guidance documents, instituting quality assurance measures, and modifying FDA’s treatment of high-risk devices.
The 510(k) is the most commonly used pre-market notification pathway for medical devices. The number of applicants, which exceeded 3,000 in 2017 alone, continues to motivate FDA to create and update methods for streamlining the path to approval. Since 2009, FDA issued numerous guidance documents which, among other things, clarified agency expectations regarding how applicants should modify existing devices and incorporate risk-benefit factors. In response to these guidelines, submissions have more than doubled in length, while review time has increased by 32%. Despite the extra pages and longer review period, FDA continues to meet its deadlines.
The publication addresses FDA’s Refuse-to-Accept policy, which rejects 510(k) applications that do not comply with FDA’s 52 item checklist. According to FDA, applications that are silent as to shelf life or biocompatibility, for example, are no longer accepted for review. 30% of all 510(k) submissions do not pass this initial review stage. While the policy does not bear on the ultimate issue of whether an applicant will receive 510(k) clearance, it has improved submission quality and streamlined review. FDA’s other efficiency efforts are targeted at the staff, and specifically at improving reviewer consistency. The 510(k) SMART memo is a template designed to facilitate uniform document analysis and provide reviewers with access to applicable regulations and guidelines. Use of the template is mandatory and incorporated into FDA’s Reviewer Certification Program, thus further encouraging consistent decision-making.
The last update focuses on FDA’s efforts to exclude high-risk devices, i.e., Class III devices, from the 510(k) submission process. In the past, applicant’s whose high-risk devices were approved before the 1976 Medical Device Amendments were eligible to receive 510(k) clearance. Beginning in 2011, FDA issued 24 rules and orders which either reclassified Class III devices into Class I or Class II or eliminated Class III devices from the 510(k) process by requiring a Premarket Approval Application. As a result, no Class III devices received 510(k) clearance in FY2018. To further reduce the number of devices in the 510(k) pathway which pose a high health risk, FDA intends to prevent applicants from using certain predicate devices in their application. Devices that raise safety concerns will be unavailable for use as a predicate device and may be reclassified into Class III or subject to review under Premarket Approval.