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# Shuren Sees ‘Hybrid’ Inspection Program Post Covid
- URL: https://www.fdaweb.com/shuren-sees-hybrid-inspection-program-post-covid/
- Published: 2021-05-12T12:00:00.000Z
- Updated: 2026-09-14T16:58:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149300

CDRH director **Jeff Shuren** believes FDA will likely favor a “hybrid” inspection program going forward in the post-Covid-19 world, relying both on in-person and interactive online assessments. Speaking last week at an FDA/Xavier MedCon conference, Shuren acknowledged the pandemic’s disruption on inspecting manufacturing facilities. “We tried to get creative in other ways to get information about what was going on in facilities on the device side, and we leveraged the medical device single audit program and the audits that were coming in from there,” he told the virtual conference. Last year, he said CDRH received about 2,800 such audits and they are continuing to roll in.

The device program and the Office of Regulatory Affairs began performing remote regulatory assessments in February and so far about 50 have been completed. These assessments leverage existing kinds of platforms for remote connection interfaces, like WebEx, and “so they're voluntary and they're not a true inspection, but can get important information,” Shuren said. “And certainly if you're participating in any of those, your feedback is very important for how we're trying to do this right and improve it. We're also looking at other tools and mechanisms for remote interactions and the gathering of information while looking to the future.”

Last week, FDA acting commissioner **Janet Woodcock** said the agency has developed scenarios with assumptions that can inform a return to more traditional inspection activities ([see earlier story](https://www.fdaweb.com/fda-scenarios-for-future-inspections/)). In a [report](https://www.fda.gov/media/148197/download?utm%5Fmedium=email&utm%5Fsource=govdelivery), “Resiliency Roadmap for FDA Inspectional Oversight,” she noted that from 3/2020 through 3/2021, FDA conducted 821 mission-critical inspections, including 29 in foreign countries. It also conducted 777 prioritized domestic inspections since the resumption of that work in 7/2020\. The agency said that of 13,500 applications for medical product approval or authorization received since 3/2020, an estimated 68 applications have been delayed due to the inability to conduct inspections, with most of them not mission-critical. Woodcock said inspections considered critical to the agency’s mission will continue to be the primary focus. When planning routine surveillance inspections, the agency will prioritize higher-risk establishments.

Shuren in his presentation acknowledged that Covid-19-related work at CDRH is beginning to have an impact on user fee-tracked review times, particularly with 510(k)s and PMAs. Shuren said the Center is doing its best to try to keep things on track, but it is “possible we might start to see an impact on our MDUFA performance goals out of the submissions we received in 2020 and we're monitoring that very closely.”

Covid has also had an impact on policy documents CDRH has been developing because it diverted staff to work on Covid-related guidances (28 such documents published during the pandemic). Shuren said the pandemic pushed back a Center priority to issue a proposed rule to transition from the Quality System Regulation to the International Organization for Standardization’s (ISO) 13485 standard ([see earlier story](http://fdaweb.com/login.php?sa=v&aid=D5142467&searchWords=13485&cate=S&stid=%241%24o30.RO2.%24RTOnywQ8TnDn36VYexlt30&ref=fdaweb.com)). He said the proposal is back on track. “Our goal is that it will happen this year,” he said. “It's a top priority for us and from our perspective, sooner, is a heck of a lot better than wait.” \[*editor’s note: Details on ISO 13485 transition can be found in a white paper discussed* [*here*](http://fdaweb.com/login.php?sa=v&aid=D5143883&searchWords=13485&cate=S&stid=%241%24o30.RO2.%24RTOnywQ8TnDn36VYexlt30&ref=fdaweb.com)*.*\]

Another priority policy issue that is back on track, according to Shuren, is publishing a draft guidance on medical device servicing/remanufacturing. In 2019, the agency released a white paper ([see earlier story](http://fdaweb.com/login.php?sa=v&aid=D5142659&searchWords=remanufacturing%20device&cate=S&stid=%241%24695.Vx5.%24DXTM3krc10icOU8cDfFv0/&ref=fdaweb.com)) that discussed servicing and remanufacturing activities performed on medical devices by original equipment manufacturers and third parties. It also addressed activities performed on reusable devices that can be serviced, repaired, refurbished, maintained, and/or remanufactured.

Moving to CDRH’s Medical Device User Fee Act (MDUFA) reauthorization efforts, Shuren touted an agency proposal to stand up the Total Product Life Cycle Advisory Program (TAP) that would advance postmarket device safety. He said that unlike the drug user fee program, the device program is more narrow in scope and premarket-focused. Additionally, he said CDRH presubmission efforts are under-resourced. “Quite frankly,” Shuren continued, “they're very formal, and you know, there's a longer timeframe before those formal meetings can happen.” Additional interactions, such as for breakthrough device, are not well resourced either, he said.

“We have the opportunity to transform the ecosystem, and have a major dent on what goes on across the entire product life cycle,” Shuren said. “And that's what the TAP proposal is about. It is about moving from these more structured formal interactions that we have to more informal interactions, and interactive with you... We want to move more towards having a dialog that can occur, fluid and fast across a variety of products. During the development side, and subsequent to premarket approval or clearance, and to do that, we've kind of put on the table having a cadre of advisors, and a new team of seasoned experts, who can serve as a resource. And they're really \[going to be\] a liaison out there to developers to answer a lot of basic questions that our lead reviewers just don't have the time to engage on, and secondly to bring together experts across the field.” Additionally, Shuren said that under MDUFA it will be important to stay on top of new advances that occur in science by having staff engage in experiential learning programs.