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GUIDANCE DOCUMENT

FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories October 2014

Download the Draft Guidance Document
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2011-D-0357
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This document is intended to describe the process for clinical laboratories to notify the FDA of the laboratory developed tests (LDTs) they manufacture as well as to describe the Medical Device Reporting (MDR) requirements, codified in 21 CFR Part 803, for clinical laboratories manufacturing LDTs. LDTs are those in vitro diagnostic devices (IVD) that are intended for clinical use and are designed, manufactured and used within a single laboratory.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2011-D-0357.

 
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