MDCG offers workaround for legacy devices with expiring certificates and FDA proposes framework for human factors information in device submissions
MDCG said for manufacturers that have made “reasonable efforts” to comply with MDR, competent authorities may allow legacy devices that do not pose any unacceptable risk to patient health and safety and have not undergone significant changes to remain on the market despite their non-compliance with MDR. For a product to be eligible to remain on the market under Article 97, the manufacturer should have already undertaken steps to transition their product to MDR requirements, including by getting their conformity assessment accepted by a notified body; however, MDCG said there are times when that may not be feasible. In such situations, MDCG recommends that the competent authority waive the requirement if the manufacturer is a small- and mid-sized enterprise (SME), the MDD or AIMDD certificate was issued by a notified body that has not yet been designated under MDR, and the manufacturer can show that despite their good faith efforts their product has not been certified due to a lack of available notified bodies.
The draft guidance, published on 9 December 2022, revises draft guidance issued in February 2016 called “List of Highest Priority Devices for Human Factors Review.” Once finalized, the new draft guidance is intended to complement the agency’s “Applying Human Factors and Usability Engineering to Medical Devices” guidance. The draft guidance outlines a risk-based framework about what human factors information should be included in marketing submissions for medical devices. The framework explores how to determine the human factors submission category and what to include in a marketing submission based on that category. Including appropriate human factors information in the marketing submission can improve the efficiency of the agency review by reducing the number of requests for additional information.
FDA data from FY 2018-2022 and found that during the most recent fiscal year, the agency recorded 72 medical device Class I recall events comprised of 149 product recalls. The number of recall events reflects how many recalls occurred, while the total number of recalled products may be higher as multiple individual products may be recalled within a single recall event. When looking at less serious recalls, FDA recorded a decline in Class II recall events – the most numerous type of recall – from FY 2018-2022, with 782 recall events in FY 2022, down from 1,100 in FY 2018. Class III recalls – the least serious and least numerous type – remained relatively flat over the same period, with 45 recall events in FY 2018 and 44 in FY 2022.
“Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers” draft guidance proposes recommendations to help manufacturers understand and use the VMSR program, which was developed to reduce the number of individually reported device malfunction medical device reports (MDRs) that manufacturers must submit and allows the FDA to get a more efficient understanding of certain malfunction issues via a summary report. The new draft guidance is intended to further explain, but not change, the conditions of the VMSR program, said the FDA.
(Medtech Intelligence 2022-12-14)
Experts stressed the importance of effectively managing hybrid inspections for the pharmaceutical and medical device industries in a developing enforcement environment, especially amid turnover of experienced inspectors at the FDA. One attorney asserted that FDA has limited ability to take enforcement action against firms for noncompliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) based on information collected from virtual inspections as the law mandates that violative findings can only be used against firms from onsite, boots on the ground inspections. Another attorney said it is important for companies to be able to manage the new dynamics of onsite and remote inspections. This involves building trust with investigator and “being helpful” in a way that “is not too helpful,” he said.
The European Commission’s Medical Device Coordination Group (MDCG) has adopted a definition for “hybrid audits” that offers notified bodies flexibility in terms of how long an auditor is physically present on the auditee’s premises for audits conducted by notified bodies under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR). Under the newly adopted definition, one or more auditors may be present on the premises of a manufacturer, its supplier(s) and/or its subcontractor(s) “with other members of the audit team participating from elsewhere using information and communication technologies (ICT).” “The assessment procedure must include an audit on the manufacturer’s premises both for the initial assessment and for the periodic surveillance,” MDCG said. “The same requirement applies, as appropriate, for audits to occur on the premises of the manufacturer’s suppliers and/or subcontractors.” According to MDCG, the auditor and other notified body team members may be present on the auditee’s premises for the duration of the audit, “or for a portion of that time.”
The Simbex Regulatory and Reimbursement Recap is a monthly briefing for news in the regulatory and healthcare reimbursement space relevant to Simbex areas of expertise. The briefing is curated by Amaris Ajamil, PhD, RAC, Simbex Director, Quality and Regulatory, and Angela Smalley, PhD, Simbex Senior Product Consultant. A story’s inclusion does not imply endorsement by Simbex.