FDA Medical Device Regulatory Framework — FD&C Act and CDRH
The FDA's Center for Devices and Radiological Health (CDRH) regulates medical devices in the United States under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Devices are classified into three classes based on risk and the level of regulatory control needed to assure safety and effectiveness:
- Class I (lowest risk): General controls; most exempt from premarket notification. Examples: bandages, examination gloves.
- Class II (moderate risk): General and special controls; most require 510(k) premarket notification demonstrating substantial equivalence to a predicate device.
- Class III (highest risk): General controls and premarket approval (PMA) — the most stringent pathway, requiring valid scientific evidence of safety and effectiveness. Examples: implantable pacemakers, high-risk IVDs.
Additional pathways include:
- De Novo: For novel, low-to-moderate-risk devices without a suitable predicate; creates a new device classification.
- Humanitarian Device Exemption (HDE): For devices treating rare conditions (fewer than 8,000 patients/year in the US).
- Breakthrough Device Program: Expedited review for devices providing more effective treatment of serious conditions.
📅 Effective / published: FD&C Act ongoing; significant amendments via FDASIA (2012), 21st Century Cures Act (2016), MDUFA V (2022)
Foreign manufacturers exporting to the US must designate a US Agent registered with the FDA and register their establishment in the FDA's registration database. All applicable devices must be listed with the FDA. Confirm whether your device requires premarket submission or qualifies for a general controls exemption before entering the US market.
View official source (FDA — Medical Devices) ↗