Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems - Guidance for Industry and FDA Staff
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
September 4, 2003
March 19, 2020
539786d8-803c-4849-b975-345597003187
Related Documents
Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff
Guidance DocumentDecember 18, 2003Center for Devices and Radiological Health
Non-clinical Information for Femoral Stem Prostheses: Guidance for Industry and FDA Staff
Guidance DocumentSeptember 17, 2007Center for Devices and Radiological Health
Information for Keratome Manufacturers Regarding LASIK - Final Guidance for Industry
Guidance DocumentJune 20, 2001Center for Devices and Radiological Health
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.