Aug 5, 2022

The US Food and Drug Administration (FDA) issued draft guidance on conducting remote evaluations of the manufacturing facilities and records of medical device, in vitro diagnostic (IVD) device and pharmaceutical registrants. This draft guidance was published July 25, 2022 in the Federal Register and is available for public comment until September 23, 2022.

What is a remote regulatory assessment (RRA)?

A remote regulatory assessment (RRA) is an examination of any FDA-regulated medical device, in vitro diagnostic (IVD) device or pharmaceutical manufacturer’s facilities and records to evaluate compliance with FDA requirements. The purpose of an RRA is to protect human or animal health, inform regulatory decisions and verify certain information submitted to FDA. RRAs complement FDA’s authority to conduct inspections under section 704(a)(1) of the U.S. Federal Food, Drug, and Cosmetic (FD&C) Act and other applicable FDA authorities.

Who may be subject to an RRA?

Mandatory RRAs are conducted by the FDA on establishments that “engage in the manufacture, preparation, propagation, compounding or processing of a drug,”  and are subject to section 704(a)4 of the FD&C Act. Mandatory RRAs may also be conducted by FDA under the Foreign Supplier Verification Program (FSVP), subject to section 805(d) of the FD&C Act and implementing regulations in 21 CFR 1.510(b)(3) or 1.512(b)(5)(ii)(C), as applicable.

Voluntary RRAs are defined as an RRA that is not mandatory (or FDA opts against exercising its mandatory RRA authority). FDA can request that any establishment, including food producers, tobacco product manufacturers, drug or medical device manufacturers, clinical investigators or others participate in a voluntary RRA.

How should records in response to an RRA request be provided to FDA?

Requested records or other information needs to be submitted to FDA in an electronic format. FDA will provide a secure means to send requested records and information. Before submitting electronic records and information to FDA, you should identify any limitations on access to these electronic files and make sure that encrypted and password-protected files can be accessed by FDA. In the event that only paper records are available, scan the documents as searchable Portable Document Format (pdf) files and send by secure means to FDA. As a last resort, if only paper copies of records are available, FDA will provide the name and contact information of the FDA staff member requesting the records. Please send the paper copies of records securely to this FDA staff member and include their name on your submission.

Emergo by UL will continue to post updates to US FDA RRA guidance as it becomes available.

Related resources from Emergo by UL:

  • On-site MDSAP training for medical device manufacturers
  • MDSAP and Health Canada QMS compliance support
  • Webinar: Overview of the MDSAP certification process

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  • Kathryn Burke's picture
    Kathryn Burke

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