Remote Assessments May Be Model for Device Inspections
Device manufacturers should use FDA’s remote regulatory assessment (RRA) program as a template for how the agency will likely implement remote device facility inspection authority under last year’s Food and Drug Omnibus Reform Act (FDORA), according to former CDRH Office of Compliance director Steven Silverman. Writing in a 3/20 online MedTech Intelligence post, Silverman said such remote inspections will take time to implement due to the time-consuming guidance document process, in the meantime companies can prepare for remote inspections by using remote regulatory assessments as a potential model.
“In a typical RRA, FDA asks a device maker voluntarily to provide information about its operations,” according to Silverman, who is now a principal consultant at The Silverman Group. “This might concern design controls or supplier oversight, for example, or complaint handling and adverse event reporting. Notably, this information is provided electronically (and remotely), outside a standard FDA inspection. FDA may consider the information in deciding whether to inspect the device site and what to focus on, but the agency makes no commitments in this regard. RRAs can precede, follow, and even prompt standard inspections.”
Last year, FDA released a draft guidance on the expanded use of RRAs beyond the Covid-19 pandemic to assess an FDA-regulated establishment and its records to determine compliance in lieu of conducting a physical inspection. The agency noted that RRAs will be an additional regulatory tool that does not replace inspections or other established means of obtaining information necessary for it to accomplish its public health mission.
FDA said at the time that during the past two years, it “performed more than 1,470 domestic and more than 600 foreign entity establishment RRAs. As a result of these RRAs, we’ve identified unreported adverse events, gathered information to add products that appear to be violative to import alerts, evaluated the status of companies correcting issues from a previous inspection and helped the agency make regulatory decisions for product premarket submissions. RRAs are effective in getting essential information to regulators, enabling the FDA to intervene when needed and use agency resources more efficiently to do so.”
The draft guidance, “Conducting Remote Regulatory Assessments Questions and Answers,” is intended to provide transparency about how such assessments may be used and to promote consistency in the way they are conducted. “We intend to continue to use RRAs, as appropriate, according to a risk-based approach that best protects public health,” the agency says. “For example, when we are unable to deploy in-person staff due to travel restrictions, we may determine that a RRA is an appropriate tool. RRAs may also be used to efficiently assess establishments identified in product applications when these establishments have a prior history of compliance. Where appropriate, RRAs allow the FDA to review information such as livestreams and records provided by a company without going on-site, which can make better use of limited agency resources and give industry more scheduling flexibility.”