Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
February 27, 2001
August 10, 2023
fdeed1f3-00b0-4187-bf3d-80280cc10bf4
Related Documents
Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA Staff
Guidance DocumentApril 19, 2001Center for Devices and Radiological Health
Information for Keratome Manufacturers Regarding LASIK - Final Guidance for Industry
Guidance DocumentJune 20, 2001Center for Devices and Radiological Health
Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff
Guidance DocumentMay 28, 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.