CDRH CONFERENCES AND MEETINGS -------------------------------------------------------------------------------------------------------------- Upcoming Conferences and Meetings

DEVICE REGULATIONS AND LAWS -------------------------------------------------------------------------------------------------------------- CFR GPO Access

FEDERAL REGISTER -------------------------------------------------------------------------------------------------------------- Recent Federal Register Notices

IDE / PMA / 510(k) -------------------------------------------------------------------------------------------------------------- Investigational Device Exemptions Manual Information on Premarket Approval Applications Premarket Approval Manual JUL97 Information on Releasable 510(k)s Premarket Notification 510(k): Regulatory Req For Medical Devices

DIRECTORIES -------------------------------------------------------------------------------------------------------------- Search HHS Employee Directory CDRH Organization Structure CDRH Referral List CDRH Research Areas CDRH Facility Locations Division of Small Manufacturers Assistance (DSMA)

ADVISORY COMMITTEES -------------------------------------------------------------------------------------------------------------- FDA Advisory Committees

ADVERSE EVENT REPORTING -------------------------------------------------------------------------------------------------------------- Medical Device Reporting (MDR) Safety Alerts, Public Health Advisories, and Notices From CDRH Manufacturer and User Facility Device Experience Database

EDUCATION -------------------------------------------------------------------------------------------------------------- CDRH Home page Device Advice: Getting Started Overview of CDRH Laws Regulated by FDA - Medical Devices Laws Regulated by FDA - Electronic Products

CDRH DOCUMENTS AND MANUALS -------------------------------------------------------------------------------------------------------------- CDRH Regulatory Manuals CDRH Documents Available from NTIS Clinical Reports Device Evaluation Information Design Control Guidance for Medical Device Manufacturers Device Reporting Harmonization Good Guidance Practices (GGP) Database Guidance on Electronic Products which Emit Radiation Index of CDRH Web Documents

ELECTRONIC SUBMISSIONS -------------------------------------------------------------------------------------------------------------- Electronic Submissions

INTERNATIONAL -------------------------------------------------------------------------------------------------------------- Global Harmonization Task Force Standards Organizations Links

STANDARDS -------------------------------------------------------------------------------------------------------------- CDRH Standards Program Standards Organizations

GOOD MANUFACTURING PRACTICES (GMP) -------------------------------------------------------------------------------------------------------------- GMP Requirements Quality System (QS) Regulation Information

ESTABLISHING REGISTRATION AND MEDICAL DEVICE LISTING -------------------------------------------------------------------------------------------------------------- Establishment Registration and Medical Device Listing Instructions For Forms FDA 2891, 2891a & 2892

IMPORT / EXPORT -------------------------------------------------------------------------------------------------------------- Medical Devices & Diagnostic Products Import Alerts Commercialization of In Vitro Diagnostic Devices (IVD's) Manufacturers of Medical Devices used for In Vitro Fertilization (IVF) FDA's Mammography Program Human Factors Program

FORMS -------------------------------------------------------------------------------------------------------------- Forms

COMPLIANCE -------------------------------------------------------------------------------------------------------------- Bioresearch Monitoring Office of Compliance Draft Compliance Program Manual: Inspection of Medical Devices Medical Device Warning Letter Pilot IRB/Clinical Information Sheets FDA/ORA Compliance Policy Guides