FDA officials discuss prioritizing inspections, QMSR transition

Regulatory NewsRegulatory News
| 05 May 2022 | By Joanne S. Eglovitch 

FDA's Anne Reid, Elizabeth Miller

Officials from the US Food and Drug Administration (FDA) explained how the agency is prioritizing medical device inspections as it resumes normalized operations. They also announced a new “careful and cautious” approach to conducting foreign inspections.
 
At the 4 May virtual MedCon Conference which was hosted by the Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS), officials also addressed how it will balance the use of alternative tools, such as records requests and remote interactive evaluations (RIEs) with onsite inspections.
 
At the meeting, Anne Reid, acting program director of the Office of Medical Devices and Radiological Health (OMDRHO) in FDA’s Office of Regulatory Affairs (ORA), and Elizabeth Miller, assistant commissioner for medical products and tobacco operations in ORA, provided an update on the agency’s inspection activities. They also addressed whether the agency will grant the industry more time to comply with the pending Quality Management System Regulation (QMSR).
 
Redi said that on the domestic and the international front, the agency “started the high priority” inspections and continued to conduct mission critical inspections.
 
Due to declining COVID-19 cases, the agency in February announced it was resuming inspections. (RELATED: FDA to resume routine domestic surveillance inspections next week, Regulatory Focus 4 February 2022)
 
In April, the agency announced it will be resuming normalized operations but will continue to prioritize those inspections that are critical the agency’s public health mission and will be inspecting those firmed deemed a high priority. (RELATED: FDA resuming normalized operations but will continue to leverage MRAs, Regulatory Focus 14 March 2022)
 
Reid said the agency plans to use the following factors in deeming an inspection a high priority: the firm has submitted premarket approval application (PMAs); the firm is responding to a warning letter and has corrected violations; the firm has been subject to complaints or has had a recall; or the agency sees a signal indicating a potential safety issue and “we need to come in and have a visit.”
 
Another factor is whether the product has been identified on the agency’s risk-based planning list which is updated yearly and targets a product to focus on. She said this year, the agency has identified ventilators as the product, so the agency plans to target these products for inspections.
 
Reid said these factors have been drawn from the firm’s resiliency roadmap issued last February. (RELATED: FDA tallies pandemic inspection toll, issues new ‘resiliency roadmap’  Regulatory Focus 5 May 2021)
 
Further down the list after prioritized inspections are routine surveillance inspections.
 
More ‘cautious’ foreign inspections
 
On the foreign front, Reid said the agency will be using the same type of prioritized approach to conducting foreign inspections, but the process will be “a little more careful and cautious.”  These changes were wrought by COVID-19 quarantine restrictions, which range from country to country.
 
She said, “Instead of moving between countries on three six-week trips we are trying to focus people in one country or in border states in Europe where there is not a lot of travel between countries. This is kind of a change for us.”
 
This change was prompted by resource limitations and that different rules for quarantining made it difficult for inspectors to travel to numerous countries.
 
Balancing onsite with alternative tools
 
As the pandemic lingers on, officials said the agency will continue to use alternative tools to conduct inspections, such as records request and RIEs in lieu of onsite inspections.
 
When asked how the agency plans to balance onsite inspections with alterative tools, Miller said, “One of the things my five program directors are doing at the current time is they are looking retrospectively at the return on investment for doing an RIE versus doing an onsite inspection and where that sweet spot is where we can request records and then follow- up with onsite work. ... We are actively taking that retrospective look and looking at the data so that we can develop those criteria that would help us balance what tool to use and to help use figure out” whether to use remote records, or sampling, or RIE.
 
Will agency delay QSR transition
 
In other areas, Reid was asked at the end of her presentation whether FDA will delay the one-year transition date for complying with a final Quality System Management Regulation (QMSR) rule.
 
Reid deferred answering the question. “I want to hear from our stakeholders. You need to comment, and then we will look at the comments.”
 
In February, FDA proposed a long-awaited proposed rule to align its Quality System Regulation (QSR) with the international standard ISO 13485:2016. (RELATED: FDA proposes QSR overhaul after years of delays, Regulatory Focus, 22 February 2022)
 
The regulation gives industry a one-year transition period from when the rule is finalized. Industry argued for a longer transition period during a full-day meeting of the agency Device Good Manufacturing Practice Advisory Committee (DGMPAC) in March. (RELATED: QMSR: Industry wants to avoid ISO 13485 ‘plus,’ seeks longer transition period, Regulatory Focus 2 March 2022)
 

 

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