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 2016_register executive 2016-01-06 article Rules and Regulations D09002ee1c7f6b2e9 D09002ee1c7f6b3b6 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 classifying the intravaginal culture system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the intravaginal culture system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. 81 FR 378 https://www.govinfo.gov/app/details/FR-2016-01-06/2015-33264 2015-33264 fr06ja16-2 4164-01-P Docket No. FDA-2015-N-4408 https://www.govinfo.gov/app/details/FR-2016-01-06/2015-33264 https://www.govinfo.gov/content/pkg/FR-2016-01-06/html/2015-33264.htm https://www.govinfo.gov/content/pkg/FR-2016-01-06/pdf/2015-33264.pdf Medical Devices 3 p. 378 380 81 FR 378 Title 21 Part 884 21 CFR Part 884 Medical Devices; Obstetrical and Gynecological Devices; Classification of the Intravaginal Culture System; Federal Register Vol. 81, Issue RULE 2015-33264 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2015-01-06 Docket No. FDA-2015-N-4408 4164-01-P 2015-33264 Final order.

The Food and Drug Administration (FDA) is classifying the intravaginal culture system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the intravaginal culture system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

This order is effective January 6, 2015. The classification was applicable on November 2, 2015. Jason Roberts, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G218, Silver Spring, MD 20993-0002, 240-402-6400, jason.roberts@fda.hhs.gov. Medical Devices Medical Devices: Obstetrical and Gynecological Devices; Classification of the Intravaginal Culture System , jason.roberts@fda.hhs.gov http://www.regulations.gov Vol. 81, no. 3 Office of the Federal Register, National Archives and Records Administration 2016-01-06 continuing daily deposited born digital 353 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-01-06 P0b002ee18e3ff337 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr06ja16 https://www.govinfo.gov/app/details/FR-2016-01-06 https://www.govinfo.gov/content/pkg/FR-2016-01-06/pdf/FR-2016-01-06.pdf https://www.govinfo.gov/content/pkg/FR-2016-01-06/xml/FR-2016-01-06.xml fdlp 371 718 DGPO 2016-01-06 2024-06-02 FR-2016-01-06 machine generated eng FR FR-2016-01-06 81 3