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2019-04-26
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Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
Notices
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United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions.'' FDA has developed this document to describe relevant information that should be included in test report summaries, test protocols, and complete test reports for non-clinical bench performance testing provided in a premarket submission (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, and De Novo requests).
84 FR 17838
https://www.govinfo.gov/app/details/FR-2019-04-26/2019-08466
2019-08466
fr26ap19-59
4164-01-P
Docket No. FDA-2018-D-1329
https://www.govinfo.gov/app/details/FR-2019-04-26/2019-08466
https://www.govinfo.gov/content/pkg/FR-2019-04-26/html/2019-08466.htm
https://www.govinfo.gov/content/pkg/FR-2019-04-26/pdf/2019-08466.pdf
3 p.
17838
17840
84 FR 17838
Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability; Federal Register Vol. 84, Issue
NOTICE
2019-08466
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2018-D-1329
4164-01-P
2019-08466
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions.'' FDA has developed this document to describe relevant information that should be included in test report summaries, test protocols, and complete test reports for non-clinical bench performance testing provided in a premarket submission (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, and De Novo requests).
The announcement of the guidance is published in the Federal Register on April 26, 2019.
Jismi Johnson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1524, Silver Spring, MD 20993-0002, 301-796-6424.
Guidance:
Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions
,
CDRH-Guidance@fda.hhs.gov
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 81
Office of the Federal Register, National Archives and Records Administration
2019-04-26
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211 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2019-04-26
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https://www.govinfo.gov/app/details/FR-2019-04-26
https://www.govinfo.gov/content/pkg/FR-2019-04-26/pdf/FR-2019-04-26.pdf
https://www.govinfo.gov/content/pkg/FR-2019-04-26/xml/FR-2019-04-26.xml
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FR-2019-04-26
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