Recognized Consensus Standards
The CDRH Standards Program:
- Created as a result of the Food and Drug Administration Modernization Act (FDAMA) of 1997. The Standards Management Staff (SMS) is responsible for facilitating the recognition of national and international medical device consensus standards.
- Modifications to the list of recognized consensus standards: Publications in the Federal Register to the list of recognized consensus standards can be accessed at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
- Please note that changes to the recognized consensus standards database are updated the following Monday.
- De Novo
- Medical Device Reports (MAUDE)
- CDRH Export Certificate Validation (CECV)
- CDRH FOIA Electronic Reading Room
- CFR Title 21
- Device Classification
- FDA Guidance Documents
- Humanitarian Device Exemption
- Medsun Reports
- Premarket Approvals (PMAs)
- Post-Approval Studies
- Postmarket Surveillance Studies
- Radiation-Emitting Products
- Radiation-Emitting Electronic Products Corrective Actions
- Registration & Listing
- Total Product Life Cycle
- X-Ray Assembler