FDA Remote Regulatory Assessments Are Here To Stay

FDA’s Proposed Guidance on Conducting Remote Regulatory Assessments

Remote. Remote. Remote. Since the COVID-19 pandemic started in 2020, this is the word we now use most often to describe how we meet, collaborate and share knowledge. Our entire workplace has shifted to remote settings, remote meetings, and remote conferences. As many businesses and workplaces have transitioned to using remote options in lieu of travel in this endemic period, FDA is doing the same.  

To support this transition, FDA published a draft guidance on conducting remote regulatory assessments (RRAs). We read so you don’t have to – below are some key areas of interest to the Life Science industry:

  • RRAs are an entirely remote examination of a regulated establishment and/or its records to determine compliance with FDA requirements which can be voluntary or mandatory.
  • FDA can initiate (mandatory) or request (voluntary) an RRA whenever they determine it is appropriate via a risk-based approach.  
  • RRAs are not considered inspections nor will they be used at the same time as inspections. Also, they will not limit or replace other established means of obtaining information outside of inspections.
  • Voluntary RRA expectations:
    • FDA can request an RRA soliciting top management or senior designees to provide written confirmation of ability and willingness to participate. FDA will work with the company to confirm technological capabilities, request records or other information, and schedule virtual interviews and meetings as needed.
    • There are no consequences for declining a voluntary RRA.  However, this may lead to an ill-timed assessment of the organization due to the lack of information and may require other actions to verify or obtain submitted information.
  • Mandatory RRA expectations:
    • For mandatory RRA requests, FDA will follow section 704(a)(4) of the FD&C Act for drug establishments and Form FDA 4003 to request records or other information.
    • If a mandatory RRA is declined, the establishment may be in violation of the FD&C Act and be subject to appropriate regulatory action.
  • Depending on the type of RRA, companies can expect requests and reviews of records, documentation, and other information and/or virtual meetings to review the provided information, systems operations or SOPs. Businesses could also expect the use by the FDA of pre-recordings or livestreams to examine facilities, information, data or operations.
  • Due to the virtual nature of the RRAs, there are technological expectations depending on the kind of RRA including, but not limited to, recording and livestream capabilities, security, and privacy controls. If an establishment is unable to support these technologies or if it is determined that the virtual interaction does not permit a sufficient examination, FDA may use other available tools or may terminate the RRA.
  • Electronic Submissions:
    • Records or other information should be submitted in an electronic format. If records are kept in paper format, they should be scanned as secure and searchable Portable Document Format (PDF) files.
    • If the records requested are part of 704(a)(4), they can be submitted in either electronic or physical form.
    • However, for certain RRAs the records must be sent electronically, or delivered quickly through other means upon written request from FDA.
  • When the RRA is completed, FDA may follow up in a few ways including a meeting with the establishment’s management or a written list of observations (if any) in sufficient detail to ensure clarity and allow for appropriate response. A form FDA 483, Inspectional Observations, will not be issued for an RRA.   FDA’s RRA list of observations is not considered a final action or decision but could be used as evidence for such events. RRAs may lead to on-site inspections by the FDA if significant issues are discovered Appropriate actions, including enforcement actions may then be taken.

In Brief

Just like you, FDA is transitioning to the remote work environment. Axendia has been discussing the transition from on-site to remote metrics based inspections for several years.

To learn more, check out our articles FDA to Rate Industry on Quality Management Maturity and Quality Metrics Support Improved Quality Across the Value Network. For a comprehensive understanding of the information, please read the full FDA draft guidance on RRAs.

We will continue to provide updates on FDA’s RRA Guidance as they become available.

Contact research@axendia.com to schedule an Analyst Inquiry on this topic.

The opinions and analysis expressed in this Briefing Note reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this document is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This document is not intended to endorse any company or product and should not be attributed as such.

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