21 CFR 801.127
§ 801.127 Medical devices; expiration of exemptions.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 801.127, § 801.127 Medical devices; expiration of exemptions, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88681
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Full text
(a) If a shipment or delivery, or any part thereof, of a device which is exempt under the regulations in this section is made to a person in whose possession the article is not exempt, or is made for any purpose other than those specified, such exemption shall expire, with respect to such shipment or delivery or part thereof, at the beginning of that shipment or delivery. The causing of an exemption to expire shall be considered an act which results in such device being misbranded unless it is disposed of under circumstances in which it ceases to be a drug or device.
(b) The exemptions conferred by §§ 801.119, 801.122, and 801.125 shall continue until the devices are used for the purposes for which they are exempted, or until they are relabeled to comply with section 502(f)(1) of the act. If, however, the device is converted, or manufactured into a form limited to prescription dispensing, no exemption shall thereafter apply to the article unless the device is labeled as required by § 801.109.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.