FDA Releases Draft Guidance for Remote Regulatory Assessments

The FDA has released a draft guidance for its use of remote regulatory assessments (RRAs), which is an outgrowth of the virtual inspections the agency conducted during the COVID-19 pandemic. These assessments have a number of potential uses, and can ease the burden for device manufacturers compared to on-site inspections in some instances.

The draft describes a range of circumstances for which an RRA would be applicable, including conditions that make an on-site inspection impossible or exceptionally difficult. An RRA can be used as part the agency’s handling of recalls and warning letters as well, but may also allow the FDA to fulfill its responsibilities for preapproval inspections for PMA applications.

The RRA builds somewhat loosely on the electronic audits conducted during the COVID-19 pandemic, during which the FDA said it conducted more than 600 virtual inspections of manufacturing sites located outside the U.S. The agency conducted another 1,470 of these virtual inspections for domestic sites during the pandemic, activities which the agency said allowed it to make a number of regulatory decisions for premarket submissions. Those virtual inspections also disclosed information about unreported adverse events and products that may have violated import alerts related to products for the pandemic.

The draft guidance describes both voluntary and mandatory RRAs, but at present, the agency lacks the statutory authority to require device manufacturers to release records to the FDA. The Biden administration’s budget request includes a petition for Congress to grant the agency that authority for medical device manufacturing sites, an authority that is already available for drug manufacturing operations. The scope of the draft covers all FDA-regulated products, including food, animal drugs and biologics. Because the agency cannot require an RRA for device manufacturing sites, it may not be able to require an RRA for a site that makes a device-led combination product, either.

The records that the FDA may request include those for manufacturing operations and clinical trials, and the records of an RRA would be available to the public via a request under the Freedom of Information Act. Another parallel between the RRA and a traditional inspection is that the manufacturer would have 15 working days to respond to the findings. The agency would reserve the right to act on those findings in much the same way it does for inspections, but it is not clear whether the FDA would conduct a subsequent on-site inspection prior to undertaking any related enforcement action.

The term RRA covers a number of different types of activities, such as remote interactive evaluations and remote record reviews. However, the draft guidance emphasizes that RRAs are not intended to serve as an alternative to site inspections for ordinary regulatory purposes. RRAs can be used in preparation for an inspection or to follow up on a complaint about a medical device, but the FDA will selectively use the RRA depending on the circumstances. The location of the manufacturing site is one consideration, as is the facility’s compliance history.

The complexity of the product(s) made at the site will also play a role in determining the appropriateness of an RRA, but each of the product centers will come to its own determination as to how this risk-based calculation will be handled. However, the draft guidance states that the agency will in no instance conduct simultaneous RRAs and on-site inspections.