Remote Regulatory Assessments
Remote Regulatory Assessments
By Alvin J. Lorman, AAHP Counsel
COVID-19 changed the way most people and most organizations operated. Like working from home, some of those changes have lasted beyond COVID. When COVID curtailed the ability of the U.S. Food and Drug Administration (FDA) to conduct inspections safely, the agency turned to a variety of electronic substitutes. The agency’s ability to use many of those substitutes is now part of the FD&C Act. As such, FDA needed to come up with a new acronym, so we now have RRAs — Remote Regulatory Assessments.
What exactly is an RRA? In Draft Guidance for Industry in the form of Questions and Answers issued last month, FDA said that an RRA is:
“an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements. RRAs assist in protecting human and animal health, informing regulatory decisions, and verifying certain information submitted to the Agency.”
A copy of the Draft Guidance is available here.
Two Types of RRAs: Mandatory and Voluntary
Mandatory RRAs involve establishments that are subject to inspection under Section 704 of the Act, including any facility in which drugs are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction. FDA is authorized by law to require that any records or other information that it could inspect in person to be provided to the agency in advance of or in lieu of an inspection, “within a reasonable timeframe, within reasonable limits, and in a reasonable manner, and in either electronic or physical form, at the expense of such person.” FDA’s Draft Guidance says that it “intends to make clear the authorities under which the RRA is being requested” when it initiates a mandatory RRA. Note that FDA also said that, “for requests for records and other information under section 704(a)(4), FDA does not intend to issue a Form FDA 482, Notice of Inspection or Form FDA 483, Inspectional Observations during the RRA process.”
A voluntary RRA is any RRA that is not mandated by statute or regulation. The Draft Guidance states that FDA will obtain the establishment’s consent to the RRA before it begins the RRA, preferably in writing. According to the agency, FDA will obtain the establishment’s consent to the RRA before it begins the RRA. Where practicable, FDA generally intends to seek to obtain such consent in writing. This typically includes:
- Notifying the establishment’s point of contact of the purpose and planned scope of the RRA and of the right to refuse consent; and
- Requesting that such person confirm the establishment voluntarily consents and has the ability to participate in the voluntary RRA requested.
If the establishment consents to the voluntary RRA, FDA will typically provide an opportunity to discuss, as applicable and appropriate:
- FDA’s expectations for, and any establishment limitations in participating in the RRA.
- The scheduling of virtual interviews and meetings.
- Technological capabilities.
- The process and timeline for requesting records or other information for review.
- How and when FDA will provide feedback to the establishment.
- Any questions relating to the process or other aspects of the RRA.
As this is an evolving field, regulated companies should make sure that appropriate personnel are aware of the RRA process and the need to keep required documents up to date.