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Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories October 2014


Not for implementation. Contains non-binding recommendations.

Docket Number:
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This document describes a risk-based framework for addressing the regulatory oversight of a subset of in vitro diagnostic devices (IVDs) referred to as laboratory developed tests (LDTs). This document is intended to provide guidance to clinical laboratories that manufacture LDTs about how FDA (the Agency) intends to enforce authorities that apply to such laboratories as medical device manufacturers under the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act).

Submit Comments

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-0360.

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