FDA Launches Remote Regulatory Assessments

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FDA dispensed with routine onsite inspections in the early days of the pandemic, but it took until February 2021 for it launch a platform for conducting remote audits. In mid-February, FDA’s Office of Regulatory Affairs announced its Remote Regulatory Assessments program. Excerpted from Market Pathways' recent 'From the Expert' column.

The RRA program’s goal is to support FDA’s ability to keep tabs on device companies’ quality and manufacturing practices even as travel and distancing restrictions remain in place, while also establishing a practice that can help supplement the inspection program over the long term after the pandemic is finished.

Trang Cox, a supervisory consumer safety officer within ORA’s Office of Medical Device and Radiological Health Operations discussed the RRA program during an April 20 session convened by Massachusetts-based device trade association MassMEDIC. Three overarching takeaways from Cox’s presentation:

  • RRAs are voluntary. FDA is reaching out to certain companies and inviting them to participate, but firms are under no obligation to do so.
  • The remote assessments do not in any formal or legal sense take the place of an onsite inspection. But, informally, they may allow a company to go much longer without having to undergo a routine facility inspection from FDA.
  • It is a document-based process. The RRA will be totally focused on records that firms are required to maintain under the law, addressing the four main subsystems of a firm’s quality management system. Nothing out of that scope will be requested.

As of mid-April, the agency had reached out to 83 companies with an informal note from an official asking if the firms are willing and able to undergo an RRA. If the company agrees to move forward, FDA will follow up with a formal invitation that includes the process details and an inspector will schedule a virtual session to initiate the assessment.

As of mid-April, about 50 companies agreed to participate and the agency conducted 36 remote assessments under the program.

The assessment will start with a video conference in which the FDA inspector will perform an initial interview with the company representatives about their processes and procedures and then move into making requests for particular records.

The anticipated process is the investigator will request records, the firm will share those records, and also provide context. The investigator will then likely review those records offline, and the two sides will reconvene to discuss observations the next day or at the next scheduled meeting time.

At the end of the assessment, the investigator will explain the key findings verbally, similar to what might happen during a close-out meeting at the end of standard inspection. But, unlike an inspection, the agency will not provide an FDA Form 483 detailing official findings or any other written record of the audit.

Nonetheless, companies should take good notes, as it will behoove them to send a written response to FDA about any actions in the works to address the observations, Cox said. FDA recommends a response within 15 days after the RRA, the same response timeline that is recommended following an onsite inspection.

Cox argues that there are tangible reasons for companies to participate. First, she noted, although RRAs don’t officially count as inspections, FDA is factoring them into its inspection work planning. So, if a company is up for routine inspection and it undergoes an RRA without any serious concerns, “we would probably not conduct another inspection unless there is ‘for cause.’” That means a facility could avoid a much more time- and resource-intensive FDA visit for years.

Second, it can help a company identify and correct minor, easily correctable deficiencies so the next time FDA does visit, it is more likely to go smoothly.

And third, the RRA might check the necessary boxes for companies seeking government contracts or access to foreign markets by showing the firm is in good standing with its domestic regulator, Cox said.

Excerpted from Knocking on Your Virtual Door: A Guide to FDA’s Remote Regulatory Assessments,” Market Pathways, May 4, 2021.


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