US · guidance
CMS Pub. 100-02, ch. 14, § 30
Hospital Institutional Review Board (IRB) Approved Non-significant
Risk Devices
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
Clinical trials for non-significant risk devices (devices which do not require an FDA-approved IDE) are the responsibility of the hospital’s IRB. While these devices do not
require an FDA-approved IDE, many of the FDA-approved IDE requirements apply to
these non-significant risk devices (e.g., they may not be legally marketed). Medicare
contractors are responsible for making the coverage determinations on non-significant
devices that are the responsibility of the hospital’s IRB. Contractors should apply the
same coverage criteria, where appropriate, to these devices as are applied to FDA-approved IDE Category A and B IDE devices.
History
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-08-25
- Edition
- iom-2026-08-25
- Content hash
28c1e48d5327e9f0771b14c8243d58622b76f40ccd91f1b615307968eed808ca
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