FDA-STERILITY Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff

FDA-STERILITY - 2016 EDITION - CURRENT
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Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff


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Document Number

1615

Revision Level

2016 EDITION

Status

Current

Publication Date

Jan. 21, 2016

Page Count

11 pages