Submissions include approval applications, clearance filings, adverse event reports, periodic safety reports, and correspondence with agencies including deficiency letters and warning letters.
Much material is publicly available through agency databases.
Alternative Names:
Regulatory File Discovery, Agency Submission Discovery
Why it Matters?
Agency correspondence is where the most useful material sits, since deficiency letters and warning letters document regulator concerns the manufacturer's own files may present differently. Adverse event reports establish the timeline of hazard knowledge for post-sale duty and continuing duty claims. Substantial portions are publicly available, which means the manufacturer's production adds internal deliberations rather than the underlying submissions.
Frequently Confused with
Related terms
Frequently asked questions
What material is most useful?
What does the manufacturer's production add?
