Compliance Policy Guide Sec. 390.200 Determination by Secretary that Product Fails to Comply or has Defect – 21 CFR 1003.11

Issue Date: November 1, 2012
Issued by: Center for Devices and Radiological Health
Topic(s): Investigation & Enforcement,
Status: Final

Compliance Policy Guide Sec. 390.200 Determination by Secretary that Product Fails to Comply or has Defect – 21 CFR 1003.11

This compliance policy guide provides FDA’s policy on electronic products that fail to comply or has a defect under 21 CFR 1003.11.

Download the Guidance Document