July 16, 2021
FDA Remote Regulatory Assessment
For the U.S. medical device jurisdiction, a client and I a couple weeks ago went through an FDA Remote Regulatory Assessment (RRA). Here’s a recap:
FDA contacted the firm and informed them that, due to the current SARS-CoV-2 (COVID-19) situation, the FDA is conducting inspections [called Remote Regulatory Assessment (RRA)] on a limited basis at this time. FDA said they were offering the RRAs to firms based on risk, meaning that high-risk firms (e.g., high risk class, poor past inspection results, etc.) would not generally be eligible for the RRA process. FDA proposed a date for conducting the RRA. FDA explained that an RRA is a review of records and information provided by the inspected firm to gain information and to evaluate the firm’s Quality System. The RRA was conducted by a Consumer Safety Officer.
FDA states that the RRA is a voluntary activity that will not result in regulatory action due to non-participation. RRAs may be limited in scope or terminated at the discretion of the Agency. The RRA is limited to reviewing information that can be provided electronically. FDA says that the firm’s ability to do so should factor into its decision for participation.
Refusal to provide information during the RRA is not a refusal under FDA’s inspection authority found in Section 704 of the Act (21 USC 374). Similarly, FDA does not present a Form FDA 482 at the beginning of the RRA, nor does FDA issue a Form FDA 483 at the end even if objectionable conditions are discovered during the RRA. At the conclusion of the RRA, a discussion of findings is held with management officials describing any items FDA wants to bring to the firm’s attention.
Here comes the caveat: Based on the outcome of findings from the RRA, FDA may consider “further communication and/or action”. If significant deficiencies are noted, FDA may begin an onsite regulatory inspection for the purpose of protecting public health. If that’s necessary, then the designated management official will be notified.
We found the RRA to be very informal and pleasant (just short of a trip to the dentist), where information was exchanged merely via telephone, email, and via Zoom online meetings. There was no virtual walk-around of the facility. When all was said and done, three partial days (few hours per day) was spent in the assessment.
Finally, the best news of all: FDA said that the RRA would satisfy the statutory inspectional requirement, thus resetting the firm’s cycle/queue for inspection assignments made via FDA’s inspection scheduling system (e.g., in FACTS).