FDA Resumes Inspections, But Keeps Remote Alternatives. Inside the Proposed Rule to Harmonize QSR and ISO 13485 + Warning Letter Breakdown
Regulators are restarting inspections while hanging onto remote reviews. The QSR may finally be harmonized with ISO 13485. And we look at lapses in validation and testing.
Welcome to Insider issue #4.
And welcome to the 358 new life science professionals who joined since we launched this newsletter in early July!
This month, we’re covering FDA’s recent announcement that it’s resuming normalized inspections but will continue leveraging Mutual Recognition Agreements (MRAs) and Remote Interactive Evaluations (RIEs).
Since we recorded this month’s issue, FDA issued new Q&A draft guidance covering how its Remote Regulatory Assessments (RRAs) are conducted. This article in RAPS distills some of its key points.
We're also covering the device industry’s milestone proposed rule that would overhaul the QSR to harmonize it with ISO 13485.
Lastly, we break down an FDA warning letter that offers insight into validation compliance.
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