Recognized Consensus Standards: Medical Devices
This database provides the most up-to-date list of voluntary consensus standards to which FDA will accept a Declaration of Conformity for medical devices. After FDA has decided to recognize a standard, we will update our online database to reflect the decision even before formal recognition of the standard occurs by publication in the Federal Register. Publications in the Federal Register to the lists of recognized consensus standards can be accessed at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents6.
The following guidance document is applicable to all recognized standards:
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- 510(k)s9
- De Novo10
- Medical Device Reports (MAUDE)11
- CDRH Export Certificate Validation (CECV)12
- CDRH FOIA Electronic Reading Room13
- CFR Title 2114
- CLIA15
- Device Classification16
- FDA Guidance Documents 17
- Humanitarian Device Exemption 18
- Medsun Reports19
- Premarket Approvals (PMAs)20
- Post-Approval Studies21
- Postmarket Surveillance Studies22
- Radiation-Emitting Products23
- Radiation-Emitting Electronic Products Corrective Actions24
- Recalls25
- Registration & Listing26
- Total Product Life Cycle27
- X-Ray Assembler28