ARTICLE SUMMARY:
Onsite device facility inspections have largely been put on hold during the COVID-19 response, but there have been some important developments and debate on the topic of inspections in recent weeks, as reported by our regulatory and policy editors at Market Pathways,
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Medical device design and manufacturing is no simple matter. Regulators and professional auditors have long leveraged multi-day visits to device facilities as a tried-and-true method for reaching an understanding of each company’s processes and an assurance of quality. Right now, though, as with so many things amid COVID-19 stops and starts, that practice is not exactly running routinely. But even as facility visits have been largely stalled, there have been some important developments and debates on the topic in recent weeks.
Part of that focus and activity on inspections is a direct result of the pandemic predicament. Because in-person audits are largely off-limits, device firms and their overseers have had to grapple with what can be accomplished without the site visit. How far can document sharing and video conferencing be leveraged?
The evolving consensus on so-called remote, or virtual, audits is there is a lot that can be accomplished with modern technology, but it is not an easy, inexpensive alternative to standard audits. Remote audits—which are seeing increased use in recent months—require serious preparation, technology investment, and security assurances to be successful, according to a recent expert guide in Market Pathways. (See “Tips for Remote Audit Success,” Market Pathways, June 22, 2020.) Some elements of device production are difficult, or impossible, to gauge without being onsite. And the lack of in-person interaction tends to make remote audits inherently more stressful and unsatisfying, according to some in industry who have experienced them. “They're horrendous,” one veteran regulatory affairs director at a European-based device company told me. “No matter how good your technology is, it's not the same.”
The question of remote audits is a particularly crucial one right now in Europe. Device firms are trying to take advantage of a one-year postponement to the Medical Device Regulation that ends next May, but the European Commission is not currently allowing initial MDR certification audits to be conducted remotely by notified bodies. That means many companies’ plans to win CE marks under the new regulation are now stalled in the midst of COVID-19 travel and distancing restrictions, an issue Market Pathways explored in a recent feature article. ( See “MDR at a New Standstill: COVID-19 Distancing Defers Certification Audits,” Market Pathways, June 22, 2020.)
Industry groups are pushing hard for more flexibility from the Commission. The key policymaking body, the EU Medical Device Coordination Group, has been convening its subgroups for meetings over the past two weeks and will wrap up with a full MDCG videoconference meeting on July 2-3. The EU device sector is hoping a decision will come out of those meetings allowing more reliance on remote audits for the MDR, and that such a policy will be announced publicly soon.“I would imagine they need to sort out a topic like this before September, because otherwise the damage might have been done by then,” MedTech Europe’s Oliver Bisazza told Market Pathways.
In the US, the debate about remote audits isn’t quite as hot because many fewer device approvals stand to be impacted by a lack of inspections. Most US device reviews don’t require a site visit in advance of a clearance or approval, although a pre-approval inspection is required for original PMA submissions. FDA has largely put off routine surveillance inspections in recent months, relying on alternative methods such as remote records review, as needed. But the agency has also said it will identify “mission critical inspections” that could include pre-approval and for-cause inspections, where investigators visit a facility “with appropriate safety measures in place.” To what extent any PMA reviews have been delayed by COVID-19 inspection policies is not clear. There has been no obvious drop-off in PMA approvals coming out of the agency as of yet.
Meanwhile, in the past month, FDA has issued two important documents, albeit less relevant during the COVID-19 era, detailing device inspection policies. On June 4, FDA issued a 46-page Compliance Program Guidance Manual laying out all of the considerations for FDA investigators when they carry out inspections of combination-product manufacturers. It addresses how investigators should consider the streamlined approach to Good Manufacturing Practice/Quality System Regulation compliance that combo product makers are allowed to leverage based on a 2013 regulation.
And in the past few days, the agency finalized a guidance document that stipulates “processes and standards” for device facility inspections, including standard timelines, such as an expectation that FDA will provide a “pre-announcement notification” that investigators are coming at least five days before an inspection starts. The guidance largely tracks the draft version that was issued in March 2019. Industry had hoped for more changes. For instance, AdvaMed requested a clarification that the processes and standards laid out in the guidance apply to combination product facilities, even if the device center is not the lead review center for the relevant products. FDA neglected to include that clarification, and it also largely declined to adjust some of its conditional language (e.g., terms like “generally,” “to the extent possible,” and “when time and circumstances permit”) accompanying its inspection commitments, despite industry's request.
These, however, are likely debates for another, post-pandemic day.
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