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 2017_register executive 2017-05-16 article Notices D09002ee1c7f193eb D09002ee1c7f19475 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 or the Agency), Center for Devices and Radiological Health (CDRH), is establishing a public docket to request comments related to the FDA Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. The purpose is to gain insight regarding the development and overall design/approach of the ASCA pilot program including program goals, pilot standards, design concepts, and overall program approach. The Agency is interested in gathering additional information to increase the efficiency of the ASCA Program. 82 FR 22548 https://www.govinfo.gov/app/details/FR-2017-05-16/2017-09850 2017-09850 fr16my17-65 4164-01-P Docket No. FDA-2017-N-1067 https://www.govinfo.gov/app/details/FR-2017-05-16/2017-09850 https://www.govinfo.gov/content/pkg/FR-2017-05-16/html/2017-09850.htm https://www.govinfo.gov/content/pkg/FR-2017-05-16/pdf/2017-09850.pdf 3 p. 22548 22550 82 FR 22548 Request for Comments on Food and Drug Administration Accreditation Scheme for Conformity Assessment Pilot Program; Federal Register Vol. 82, Issue NOTICE 2017-09850 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2017-06-30 Docket No. FDA-2017-N-1067 4164-01-P 2017-09850 Notice; request for comments.

The Food and Drug Administration (FDA or the Agency), Center for Devices and Radiological Health (CDRH), is establishing a public docket to request comments related to the FDA Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. The purpose is to gain insight regarding the development and overall design/approach of the ASCA pilot program including program goals, pilot standards, design concepts, and overall program approach. The Agency is interested in gathering additional information to increase the efficiency of the ASCA Program.

Submit either electronic or written comments or information by June 30, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 30, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of June 30, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287, standards@cdrh.fda.gov. standards@cdrh.fda.gov http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 82, no. 93 Office of the Federal Register, National Archives and Records Administration 2017-05-16 continuing daily deposited born digital 228 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2017-05-16 P0b002ee194d73c91 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr16my17 https://www.govinfo.gov/app/details/FR-2017-05-16 https://www.govinfo.gov/content/pkg/FR-2017-05-16/pdf/FR-2017-05-16.pdf https://www.govinfo.gov/content/pkg/FR-2017-05-16/xml/FR-2017-05-16.xml fdlp 22389 22607 DGPO 2017-05-16 2024-06-01 FR-2017-05-16 machine generated eng FR FR-2017-05-16 82 93