The FDA wants to keep and expand its ability to remotely conduct safety assessments even after the COVID-19 pandemic.
The federal agency recently detailed its plans in new draft guidance for remote regulatory assessments (RRAs) covering all FDA-regulated products. FDA staff started conducting remote assessments when unable to travel due to COVID-19 restrictions, and regulators said RRAs will continue to be valuable beyond the pandemic.
RRAs have been as simple as reviewing records, but also include voluntary interactive evaluations such as livestreaming video of operations, teleconferences and screen sharing.
Are FDA remote assessments mandatory for medical device manufacturers?
Medical device manufacturers won’t be required to participate, but it will be mandatory for drug manufacturing facilities, including those involved with drug-led drug-device combinations.
The FDA said it won’t take enforcement action against a company for declining a voluntary RRA request, but warned of potential consequences.
“FDA may not be able to provide an applicant with a timely decision on an application or product’s approval, clearance, or authorization if we lack information about an establishment referenced in the marketing submission,” the FDA said.
And if the FDA can’t get the information it wants through a voluntary RRA, it could move forward with an inspection or other actions.
A drug maker that refuses a mandatory RRA or withdraws cooperation could find itself in violation of the Federal Food, Drug, and Cosmetic Act.
How will FDA decide whether to conduct a remote evaluation?
The FDA said it will use RRAs “according to a risk-based approach that best protects public health” to make better use of its resources and to give more scheduling flexibility to the companies it regulates. For now, the FDA said it will not take requests for RRAs.
The agency said remote assessments might be appropriate if a facility has a history of compliance or when FDA staff can’t travel due to pandemics, disasters or other unstable situations. The FDA might use an RRA to help with oversight or regulatory decisions, listing examples such as preparation for a scheduled inspection, following up on consumer complaints, verifying corrective actions or supporting review of a marketing submission. When considering the use of an RRA, the FDA said it may consider a company’s location, inspection history and complexity of product and process, with different parts of the FDA assessing risk differently based on the product.
The FDA performed more than 1,470 RRAs in the U.S. and more than 600 at foreign entity establishments over the past two years.
“As a result of these RRAs, we’ve identified unreported adverse events, gathered information to add products that appear to be violative to import alerts, evaluated the status of companies correcting issues from a previous inspection and helped the agency make regulatory decisions for product premarket submissions,” the FDA said. “RRAs are effective in getting essential information to regulators, enabling the FDA to intervene when needed and use agency resources more efficiently to do so.”
Will remote assessments replace FDA inspections?
RRAs won’t replace inspections and won’t be used simultaneously with inspections, but might come before or after. The FDA does not consider RRAs as inspections because FDA officials or employees don’t physically enter the facility and won’t issue a Form 482 or Form 483.
“RRAs are not intended to limit or replace other established means of obtaining information necessary for FDA to accomplish its public health mission outside of inspections, including, among other things, applicant information request letters, registration confirmations, meetings, product submission or application assessments, or follow-up communications during outbreaks or other emergencies,” the agency said. “Similarly, if, for example, FDA calls an establishment to inform them that a submission or application is missing certain information, this is not an RRA. Although these activities may be conducted remotely, the Agency does not consider these RRAs.”
What happens during an FDA remote assessment?
The FDA said some RRAs might just require a company to find and deliver records, documents or other information for the FDA’s review. RRAs could also involve virtual meetings with the FDA and a company’s personnel to review information, systems and operations. Pre-recorded video or livestreams could also let FDA staff examine facilities, operations, data and information.
During the process, the FDA may provide updates on observations and outstanding issues. When the RRA is completed, FDA may meet with a faciity’s management and present a written list of observations, if there are any.
Those observations would cover conditions or practices that indicate a potential violation of laws enforced by FDA. This list could be released as public information if requested under the Freedom of Information Act.
Companies are encouraged to respond during the meeting and/or offer written responses within 15 business days. The FDA will consider those responses and any corrective actions in that time before taking further action or issuing a decision.
What records can the FDA request through a remote assessment?
The FDA said it will try to minimize the volume of records it requests, but that requests are similar to information sought during an inspection and could include any records or information needed to determine compliance with FDA regulations.
Those records can include:
- Production lot or batch records and product-specific information such as periodic product reviews, product quality reports, equipment records, process validation records and Current Good Manufacturing Practice-related reports, test results, product complaints or other information.
- Summaries or lists of records
- Read-only access to electronic databases or database walk-throughs, data queries or summary data
- Standard operating procedures and records of quality control and FDA compliance
- Records or data related to the reporting or conduct of FDA-regulated research
The FDA said records should be provided in an electronic format via a secure channel provided by FDA. Paper documents should be scanned and saved as PDFs if possible. The FDA may request that documents be in English or be accompanied by a translation.
Where can I learn more about the FDA’s remote assessment proposal and comment on it?
The FDA’s RRA guidance can be downloaded as a 17-page PDF. The guidance was developed by the FDA Office of Regulatory Affairs in cooperation with the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, the Center for Food Safety and Applied Nutrition, the Center for Tobacco Products, the Center for Devices and Radiological Health, and the Center for Veterinary Medicine at the FDA.