FDA Guidance Breakdown: Conducting Remote Regulatory Assessments Questions and Answers
The FDA clarifies its current thinking on RRAs.
This guidance breakdown is available in full for paid subscribers. If you’re not already a paid subscriber, you can upgrade here.
The FDA just released a Q&A draft guidance on conducting remote regulatory assessments (RRAs) to help industry teams understand and facilitate its RRA process. It addresses FAQs, such as what RRAs are, why and when the FDA uses them, and how they are conducted.
The guidance explicitly states amendments to section 704(a)(4) of the FD&C Act added device and bioresearch monitoring establishments as entities subject to mandatory requests for records or other information under this section. This means that medical device manufacturers can be compelled to provide records or other information as part of a mandatory RRA.
If you’re new to the concept of an RRA, here’s a very brief primer:
RRAs include voluntary interactive evaluations (such as remote live streaming video of operations, teleconferences, and screen sharing) and request to review records and other information under the FDA’s existing statutory or regulatory authority. Throughout the pandemic, the FDA has used these tools, domestically and abroad, to help the agency conduct oversight, mitigate risk, and meet critical public health needs.
Through RRAs, the agency can (among other things):
assess compliance of FDA-regulated products and manufacturing processes, which may enable a firm to make corrective actions prior to their next inspection;
assess the adequacy of corrective actions taken in response to previous inspections of compliant manufacturers, which may increase the time before FDA inspects a facility again or shorten the time of the next inspection;
if appropriate, make decisions related to applications submitted to the agency without conducting an inspection; and
identify unreported adverse events or incomplete corrective actions, which resulted in the agency pivoting its oversight approach to conduct an inspection and take regulatory action.
In case your time is short, we distilled the most important points from the Q&A guidance below.
An RRA is a remote examination to evaluate compliance with FDA requirements.
RRAs are conducted under legal authorities, either as mandatory or voluntary assessments.
RRAs complement, but do not replace, the FDA's authority for physical inspections.
Subjects of mandatory RRAs include establishments under section 704(a)(4) and importers under FSVP section 805(d).
RRAs are not intended to replace other established means of obtaining information outside of inspections.
RRAs may be initiated by the FDA under various circumstances, such as travel limitations or regulatory decisions.
RRAs and physical inspections are distinct and not conducted simultaneously.
The FDA may contact establishments through their point of contact, obtaining consent before starting an RRA.
RRAs can involve reviewing records, virtual meetings, and the use of livestream/video technologies.
Declining voluntary RRAs has no enforcement consequences, but mandatory RRAs have implications for non-participation.
Technological requirements for RRAs vary, including electronic submission of records and potential live streaming.
Requests for records or other information as part of RRAs
FDA may request records or information relevant to assess compliance, similar to those requested during inspections.
In mandatory RRAs, records requests conform to relevant legal authorities.
Completion of an RRA
Upon completion, FDA may present a list of observations and discuss them with establishment management.
Establishments are encouraged to respond to observations within 15 business days.
Observations from RRAs may be used in future regulatory actions or decisions.
Post-RRA actions by the FDA may include physical inspections or other enforcement actions.
Our RRA readiness checklist
Here's a brief question-based checklist that we hope helps you get to the heart of your firm's preparedness for an RRA. Talk to us for process review/development, auditing, or mock RRA/inspection support if you’re unsure of or unsatisfied with your answers to any of these questions.
Have we educated our team about what an RRA really involves?
Are we up-to-date with the latest FDA guidelines on RRAs?
When was the last time we audited, and are we confident about it?