Web(3) Initial device listing information as required by §§ 807.22(a), 807.25, and 807.28; (4) Updates to device listing information as required by §§ 807.22(b) , 807.25, and 807.28, including updates to reflect the discontinuance or resumption of the commercial distribution of a previously-listed device as specified at paragraphs (d) and (e ... Weblisting (21 CFR Part 807); labeling (21 CFR Part 801and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or
eCFR :: 21 CFR 807.21 -- How to register establishments and list devices.
WebSec. 807.21 Times for establishment registration and device listing. (a) An owner or operator of an establishment who has not previously entered into an operation defined in … Web(a) All owners or operators that are subject to the registration and listing requirements of this part shall provide such information to us by using the FDA electronic device … inbreast 数据集
eCFR :: 21 CFR 807.25 -- Information required for device …
WebJan 17, 2024 · Sec. 807.85 Exemption from premarket notification. (a) A custom device is exempt from premarket notification requirements of this subpart if the device is within the … Web(a) Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a device that is imported or offered for import into the United States shall register such establishment and list such devices using the FDA electronic device registration and listing system in conformance with the ... WebJan 17, 2024 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). PART 807 -- ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES. Sec. 807.26 Additional listing information. (a) Each owner or operator shall maintain a … inbre meaning