Today, the FDA released a draft guidance titled Conducting Remote Regulatory Assessments: Question and Answers (here). The document describes the origin of the remote regulatory assessment (RRA), its legal basis, and how it has been used, along with an explanation of the scope of its use for all FDA-regulated products. The FDA discusses the difference between voluntary and mandatory RRAs. As its name implies, the guidance is presented in a Q&A format that provides answers to the following sixteen questions:

    1. What is an RRA?
    2. Who may be subject to an RRA?
    3. Are RRAs replacing other established means of obtaining information outside of inspections?
    4. Is an RRA an inspection?
    5. When may FDA initiate or request to conduct an RRA?
    6. Will FDA use RRAs during or as part of an FDA inspection of an establishment?
    7. What are the benefits of an RRA?
    8. How may FDA request an RRA?
    9. What might an establishment expect to happen during an RRA?
    10. Are there any consequences for declining to participate in an RRA?
    11. Are there any technological expectations for an RRA?
    12. What records or other information may FDA request as part of an RRA?
    13. For what purposes may FDA use the records and other information gathered during an RRA?
    14. If the RRA requests records or other information, what is the timeframe for submitting the records and other information to FDA?
    15. How should records or other information in response to an RRA request be provided to FDA?
    16. What may occur upon completion of an RRA?

 

The RRA is another tool in the FDA’s regulatory toolbox that expands its capabilities and preserves valuable resources. Its use became prominent during the COVID pandemic, especially in the face of travel restrictions. “FDA has noted the value of RRAs and concluded that they should be used for certain scenarios outside the COVID-19 pandemic and for all types of FDA-regulated products… FDA’s experiences have identified significant benefits in using RRAs. For instance, RRAs have assisted FDA in verifying corrective actions taken in response to inspections of previously compliant manufacturers and in gaining compliance insight when it was not practicable to inspect. RRAs have also provided information about deficient practices, leading FDA to take regulatory actions and/or conduct inspections, as well as informing future inspection planning. RRAs were used to help support review and promote timely approval or authorization of marketing submissions for FDA-regulated products.”

Remember, however, that the FDA can still show up in person at your site to inspect it at any time, even after an RRA is completed. The guidance does note that there will not be an instance where an RRA and an in-person inspection will be conducted simultaneously. The document provides a great historical perspective on RRAs as well as responding to the questions addressed in a direct and straightforward manner. It’s a good read for all firms that manufacture products regulated by the FDA.