Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements." This draft guidance describes FDA's intent to exempt certain Class II medical devices and certain Class I medical devices, subject to the reserved criteria, from premarket notification requirements. FDA believes devices identified in this guidance document are sufficiently well understood and do not present risks that require premarket notification review to assure their safety and effectiveness. This draft guidance is not final nor is it in effect at this time.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2014-D-0967] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements.” This draft guidance describes FDA's intent to exempt certain Class II medical devices and certain Class I medical devices, subject to the reserved criteria, from premarket notification requirements. FDA believes devices identified in this guidance document are sufficiently well understood and do not present risks that require premarket notification review to assure their safety and effectiveness. This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5) ), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 30, 2014. ADDRESSES: An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled “Intent to Exempt Certain Class II and C…
Other Federal Register documents from the same docket.
Intent To Exempt Certain Unclassified Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability
Intent To Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability
Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability
Citation: 79 FR 44804
