The U.S. FDA’s device center may still be grappling with the COVID-19 pandemic throughout the remainder of fiscal year 2021, but that does not mean other considerations have disappeared. The FDA’s Erin Keith said the agency will keep working on a major overhaul of the quality systems regulation (QSR) but will also work toward expanding industry’s use of advanced manufacturing technologies, such as additive manufacturing.

Keith, who serves as the associate director for compliance and quality at the FDA’s Center for Devices and Radiological Health (CDRH), addressed the Food and Drug Law Institute’s annual compliance and enforcement conference with some updates and a review of the CDRH’s activities for 2020. She said the center’s compliance and quality programs have been adjusted in several key areas to address the COVID-19 pandemic, much of which was triggered by the need for new products and for new sources of existing products. However, the increased potential for fraudulent behavior has also been a major driver of enforcement differentiation at the center.

Transition planning among top priorities at CDRH

For the current fiscal year, which ends Sept. 30, CDRH is developing a plan to address the transition from policies promulgated under the public health emergency (PHE) to normal operations. Keith said a related policy document is among the items appearing on the guidance agenda for the CDRH, although it is not clear when related guidances – such as one for transitioning from emergency use authorization (EUA) to conventional premarket review – will be available.

Harmonization of the quality systems regulation (QSR) with ISO 13485, Keith said, “remains a top priority for us.” This would seem to reinforce the center’s emphasis on this effort despite skepticism by others that the agency will be able to roll out a draft rule so long as the pandemic continues to devour resources at CDRH.

Programs for device quality, such as a permanent voluntary improvement program (VIP), are also front and center at CDRH, a program that will be based on lessons learned from similar efforts leveraged by the Medical Device Innovation Consortium (MDIC). Keith said another priority is FDA participation in the MDIC program for accelerated sustainable capability pilot program, which will be directed to companies that are having trouble in sustaining consistent levels of device manufacturing quality, regardless of the source of any such problems.

Another point of interest is the development of an advanced manufacturing clearinghouse, which will assess manufacturing methods and technologies with an eye toward development of playbooks for adoption by industry. One example of this interest was announced in November 2020, as part of the response to the pandemic. The related program, dubbed America Makes, includes an interest in additive manufacturing as a potential method for rapid deployment of manufacturing technologies that could respond nimbly to public health emergencies. The National Institutes of Health and the U.S. Veteran’s Health administration are two partner federal agencies in the America Makes program.

Keith said the emphasis on fraud at CDRH is part of an agency-wide fraud task force, which convened in February 2020. This task force relies on the expertise of field inspectors and compliance officers along with special agents and analysts, who team up to analyze incoming complaints and adverse event reports to detect any worrisome signals. Any such information that proves sufficiently problematic can be used to prompt an investigation, which might involve other federal agencies as well, such as the Federal Trade Commission.

Virtual inspections also on tap

The task force had authored more than 130 warning letters as of Dec. 7, 2020, Keith said, 17 of which were for in vitro diagnostics and another 18 for non-IVD devices. Keith said not all the agency’s compliance tools are readily deployed during the pandemic, such as conventional audits and inspections. Inspections conducted under the Medical Device Single Audit Program (MDSAP), administered by the International Medical Device Regulators Forum, are just one example of other compliance programs that have been badly impeded during the pandemic to date. The consequent limitation to mission-critical inspections has fostered an intense interest on the agency’s part on a robust virtual inspection tool.

The center has issued more than two dozen guidance documents since March 22, several which were immediately in effect (IIE) policy documents. Keith noted that the text of each of these guidances and policy documents was tailored to the affected product category. One example is the policy for face masks, which was drafted to address the appropriate mask design for various risk situations, but Keith also referenced non-product guidance documents. Among these are one issued for the conduct of clinical trials during the pandemic and a policy document for medical device reporting requirements.

The number of emergency use authorization (EUA) requests received by CDRH since March 2020 numbers more than 2,900, with pre-EUA filings numbering nearly 2,000 over that same period. A total of 586 EUAs had been granted as of Dec. 7, 2020, the majority of which (296) were for tests. Respirator and ventilator EUAs were 133 and 104, respectively, Keith said.