FDA releases guidelines on remote assessments

2019 02 13 19 24 5396 Fda Logo V2 400

The U.S. Food and Drug Administration (FDA) has released a draft guidance on the expanded use of remote regulatory assessments (RRAs), including how they can be used post-COVID.

The FDA said these assessments can help determine compliance with applicable FDA requirements, inform regulatory decisions, and verify information submitted to the agency. RRAs have been used in response to the COVID-19 pandemic by getting critical medical products to the front lines, according to the agency.

The FDA added that it has performed more than 1,470 U.S. and more than 600 international RRAs.

The draft guidance is titled "Conducting Remote Regulatory Assessments Questions and Answers." It covers voluntary and statutorily authorized RRAs, but it does not change the core requirements of inspections and pre- and postmarket authorities. An RRA does not work as an inspection, except for RRAs for establishments required to comply with the Foreign Supplier Verification Programs (FSVP) regulation.

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