In Vitro Diagnostic Devices: Guidance for the Preparation of 510 (k) Subsmissions
Canon Communications LLC

Reference

FDA's official guidance for IVD manufacturers, now updated after 10 years. Includes a full description of agency requirements for IVD 510(k)s, current classifications and exemptions, and details of FDA's tier/triage program for IVDs.

In Vitro Diagnostic Devices: Guidance for the Preparation of 510 (k) Subsmissions
Format Softcover
Publisher Catalog Number IVD-71

$75.00

Vitro Diagnostic Devices Guidance Preparation 510 k Subsmissions



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