United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2015_register executive 2018-02-23 article Notices D09002ee1c7f73eb4 D09002ee1c7f73f5e United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements," which updates an earlier guidance of the same title published in the Federal Register on July 1, 2015. This guidance describes FDA's intent to exempt certain unclassified medical devices (that FDA intends to classify into class I or II), certain class II medical devices, and certain class I medical devices from premarket notification requirements. Due to an administrative error, certain comments to this Docket were not considered prior to the July 1, 2015, guidance publication. These comments have now been considered. FDA believes additional devices and product codes are sufficiently well understood and do not require premarket notification to assure their safety and effectiveness. As such, FDA is updating and adding these to the guidance. 80 FR 48868 https://www.govinfo.gov/app/details/FR-2015-08-14/2015-20005 2015-20005 fr14au15-86 4164-01-P Docket No. FDA-2014-D-0967 https://www.govinfo.gov/app/details/FR-2015-08-14/2015-20005 https://www.govinfo.gov/content/pkg/FR-2015-08-14/html/2015-20005.htm https://www.govinfo.gov/content/pkg/FR-2015-08-14/pdf/2015-20005.pdf 2 p. 48868 48869 80 FR 48868 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; Federal Register Vol. 80, Issue NOTICE 2015-20005 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2014-D-0967 4164-01-P 2015-20005 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements," which updates an earlier guidance of the same title published in the Federal Register on July 1, 2015. This guidance describes FDA's intent to exempt certain unclassified medical devices (that FDA intends to classify into class I or II), certain class II medical devices, and certain class I medical devices from premarket notification requirements. Due to an administrative error, certain comments to this Docket were not considered prior to the July 1, 2015, guidance publication. These comments have now been considered. FDA believes additional devices and product codes are sufficiently well understood and do not require premarket notification to assure their safety and effectiveness. As such, FDA is updating and adding these to the guidance.

Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. Angela C. Krueger, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993-0002, 301- 796-6380. Guidance: Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices From Premarket Notification Requirements , CDRH-Guidance@fda.hhs.gov http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm http://www.regulations.gov Vol. 80, no. 157 Office of the Federal Register, National Archives and Records Administration 2015-08-14 continuing daily deposited born digital 443 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-08-14 P0b002ee1988baefa 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr14au15 https://www.govinfo.gov/app/details/FR-2015-08-14 https://www.govinfo.gov/content/pkg/FR-2015-08-14/pdf/FR-2015-08-14.pdf https://www.govinfo.gov/content/pkg/FR-2015-08-14/xml/FR-2015-08-14.xml fdlp 48683 49116 DGPO 2018-02-23 2024-06-02 FR-2015-08-14 machine generated eng FR FR-2015-08-14 80 157