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 2014_register executive 2014-05-07 article Notices D09002ee1c7fa210b D09002ee1c7fa2189 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) Center for Devices and Radiological Health (CDRH) is announcing the availability of a CDRH eSubmissions Pilot Program (eSubmissions Pilot), which will be a new pathway that will guide the user through constructing and submitting their 510(k) submissions electronically without the requirement for submitting a hard copy or a compact disc. Participation in the eSubmissions Pilot is open to applicants whose device submissions would be reviewed in either of two branches in CDRH's Office of Device Evaluation (ODE), the Cardiac Diagnostic Devices Branch and the Peripheral Interventional Devices Branch, and is limited to unbundled, traditional 510(k) submissions for classified devices only. The eSubmissions Pilot will use the existing eSubmitter software for data acquisition and the existing Electronic Submission Gateway (ESG) for submitting (the eSubmissions Pilot is not intended to evaluate the existing eSubmitter software or the existing ESG). The eSubmissions Pilot is intended to provide industry and CDRH staff the opportunity to evaluate the 510(k) eSubmission with regards to the content (wording of questions, help text and guides), layout, and flow of the questions. 79 FR 24732 https://www.govinfo.gov/app/details/FR-2014-05-01/2014-09912 2014-09912 fr01my14-75 4160-01-P Docket No. FDA-2014-N-0366 https://www.govinfo.gov/app/details/FR-2014-05-01/2014-09912 https://www.govinfo.gov/content/pkg/FR-2014-05-01/html/2014-09912.htm https://www.govinfo.gov/content/pkg/FR-2014-05-01/pdf/2014-09912.pdf 3 p. 24732 24734 79 FR 24732 Pilot Program for Center for Devices and Radiological Health Electronic Submission of Premarket Notification Submissions; Federal Register Vol. 79, Issue NOTICE 2014-09912 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2014-N-0366 4160-01-P 2014-09912 Notice.

The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) is announcing the availability of a CDRH eSubmissions Pilot Program (eSubmissions Pilot), which will be a new pathway that will guide the user through constructing and submitting their 510(k) submissions electronically without the requirement for submitting a hard copy or a compact disc. Participation in the eSubmissions Pilot is open to applicants whose device submissions would be reviewed in either of two branches in CDRH's Office of Device Evaluation (ODE), the Cardiac Diagnostic Devices Branch and the Peripheral Interventional Devices Branch, and is limited to unbundled, traditional 510(k) submissions for classified devices only. The eSubmissions Pilot will use the existing eSubmitter software for data acquisition and the existing Electronic Submission Gateway (ESG) for submitting (the eSubmissions Pilot is not intended to evaluate the existing eSubmitter software or the existing ESG). The eSubmissions Pilot is intended to provide industry and CDRH staff the opportunity to evaluate the 510(k) eSubmission with regards to the content (wording of questions, help text and guides), layout, and flow of the questions.

FDA will begin accepting requests to participate in the eSubmissions Pilot immediately. See the "Procedures" section for instructions on how to submit a request. Patrick Axtell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1566, Silver Spring, MD 20993-0002, eSubpilot@fda.hhs.gov. Guidance for Industry and Staff: Center for Devices and Radiological Health Electronic Submission of Premarket Notification Submissions; Pilot Program , eSubpilot@fda.hhs.gov http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm221506.htm http://www.regulations.gov Vol. 79, no. 84 Office of the Federal Register, National Archives and Records Administration 2014-05-01 continuing daily deposited born digital 478 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-05-01 P0b002ee188522377 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr01my14 https://www.govinfo.gov/app/details/FR-2014-05-01 https://www.govinfo.gov/content/pkg/FR-2014-05-01/pdf/FR-2014-05-01.pdf https://www.govinfo.gov/content/pkg/FR-2014-05-01/xml/FR-2014-05-01.xml fdlp 24527 24994 DGPO 2014-05-07 2024-06-02 FR-2014-05-01 machine generated eng FR FR-2014-05-01 79 84