FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories October 2014
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
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:
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.