FDA-PIVOTAL Design Considerations for Pivotal Clinical Investigations for Medical Devices - Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff

FDA-PIVOTAL - 2013 EDITION - CURRENT



Design Considerations for Pivotal Clinical Investigations for Medical Devices - Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff


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Document Number

FDA-PIVOTAL

Revision Level

2013 EDITION

Status

Current

Publication Date

Nov. 7, 2013

Page Count

57 pages