FDA Remote Inspections - The Trend Continues

We’ve been talking about remote audits and inspections since the COVID-19 pandemic first hit — and this quality management trend isn’t going anywhere. What started as a necessity due to remote work quickly morphed into a process that regulatory authorities intend to continue well after the pandemic is over. Remote oversight proved extremely useful when travel restrictions were common and inspectors found themselves reviewing documentation and interviewing subject matter experts (SMEs) from a distance.

Remote audits and inspections are just one of the quality management trends hitting the medical device industry in 2023. To read about the others, download the trend brief.

FDA Remote Inspections

The first point to clarify here is that these aren’t actually inspections. The FDA has been very clear about that. The term being used by the U.S. Food and Drug Administration (FDA) is remote regulatory assessment (RRA). During an RRA, the FDA examines an establishment and/or its records remotely. When it comes to RRAs, medical device companies have somewhat of an advantage over pharma. An RRA is mandatory for pharma companies and refusing one is the equivalent of refusing an inspection (even though they’re not inspections…). For medical device companies, these are optional.

That being said, saying no to a request from the FDA is generally not going to be a good idea. The FDA can easily just show up at your front door and do an on-site inspection if their RRA request isn’t granted. Refusal can also delay a regulatory decision from the FDA. It’s best to try to work with the FDA on these requests as much as you can. Of course, while there’s a certain benefit to FDA remote “inspections,” there are also challenges.

Audit Management Software

If you still keep records on physical paper, an RRA is going to put your scanner through a workout. The FDA doesn’t mandate that any organizations use digital systems, but this is one situation in which it will be so much easier if you do. The difficulties of providing records during an in-person inspection still apply here, but they’re compounded by having to scan everything so that it can be sent electronically. Audit management software makes the process easier, regardless of whether we’re talking about remote or in-person audits and inspections.

Audit management software, especially if it also has document management functionality, simplifies audits or inspections by letting you easily search and retrieve documentation. On top of that, you can rest assured that the version you retrieve is the most recent one. For the best results, mock remote audits should be conducted. Performing the mock audit as if it’s an FDA remote inspection will prepare you if you do receive a request for an RRA.