Soapbox

What You Need To Know About FDA Remote Medical Device Inspections

By Steven Silverman
March 20, 2023


• Categories: 05-Quality/Regulatory, RC - EU MDR and IVDR, RC - Medical Device Audits, Certification & Verification, Regulatory, Soapbox

Back in 2021, I wrote that FDA should have the authority to inspect medical device facilities remotely. This would allow FDA to check these facilities when in‑person inspections weren’t possible. The remote inspection argument was especially compelling in the throes of Covid-19, which ground live inspections to a halt.

Last year, Congress agreed. It included language in the Food and Drug Omnibus Reform Act (FDORA) authorizing FDA to conduct remote device facility inspections. This authority permits FDA to seek records and other materials in advance of, and instead of, live inspections.

My call for remote inspections wasn’t prescient. FDA has long had authority to inspect drug facilities remotely. I just proposed parity—the same authority for device‑facility inspections.

Now FDA has remote device facility inspection authority. Yay! So what? What I mean is, what’s important about this new authority? How will it change FDA device inspections? What should device makers be ready for and do differently? And when will these changes happen?

I’ll take the last question first—when will these changes happen? The answer is, not soon. Let’s consider FDORA section 3611, which gives FDA its remote inspection authority. This section includes some prerequisites. For instance, FDA has until December of this year to issue guidance explaining how remote inspections will work. Expect FDA’s draft guidance to detail when the agency will and won’t use remote inspections, how it will announce and conduct these inspections, and how remote and standard inspections will interrelate.

FDA won’t decide these questions alone. Rather, a public-comment period follows publication of the draft guidance, in which stakeholders can speak to how FDA should conduct remote device inspections. FDA has a year after the comment period closes to finalize the guidance.

This means don’t look for remote device inspections in 2023 (and maybe not even in 2024). Remote inspections will happen, but not until FDA takes the necessary steps to make them happen.

What should device makers do in the meantime? To answer, look at device remote regulatory assessments (RRAs). I describe RRAs as “inspection lite.” These RRAs started a few years ago, before FDA had formal remote inspection authority. RRAs are not FDA inspections, but FDA has used RRAs successfully to get device facility data.

In a typical RRA, FDA asks a device maker voluntarily to provide information about its operations. 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.

I previously questioned whether device makers would agree to RRAs, especially when they don’t replace standard inspections, but I was wrong. There’s broad industry support for RRAs, and the number of participants is growing. Even with FDA now moving to remote inspections, don’t bet on RRAs disappearing. More likely, they’ll become an adjunct to remote inspections. Meanwhile, they’re a good predictor of what remote inspections will look like. FDA can apply RRA lessons learned to decide the structure, process, participants, and technologies for remote inspections.

This offers a chance for RRA participants to influence FDA thinking. These participants likely have their own views about what makes remote inspections succeed, what the obstacles are, where improvement is possible, and the benefits of such changes. As I mentioned before, FDA will seek public comment on remote inspections and insights from RRAs can help shape a successful remote inspection program. Creating this program promotes FDA‑industry collaboration, which too often is absent from inspection discussions.