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FDA Releases Details of New Framework for Laboratory Developed Tests Regulation

FDA sends notice to Congress on LDTs.

The U.S. Food and Drug Administration (FDA) has notified Congress that it intends to issue draft guidance to propose a risk-based, phased-in framework for oversight of laboratory developed tests (LDTs) and, in a strategic move, has provided the anticipated details of the LDT guidance in the notification.

The notification sent on July 31 was required by the Food and Drug Administration Safety and Innovation Act, which requires notification to Congress at least 60 days prior to the issuance of draft or final guidance. Accordingly, the highly politicized environment surrounding changes to the regulation of LDTs can be expected to continue during the 60-day waiting period as industry, academia, and other stakeholders react to the proposed framework.

FDA’s risk-based approach will rely on the existing medical device classification system (Class I, II, or III) to evaluate the risk of a category of LDTs and, informed by the expressed interest in participating in the discussion of the classification process, will use expert advisory panels to help classify devices not previously classified by FDA. FDA intends to issue draft guidance to describe what it considers generally to be Class I, II, or III within 24 months of finalizing the LDT guidance. FDA anticipates that it will phase in enforcement of regulatory requirements for LDTs over the next 10 years. The phased-in enforcement for the different device categories is summarized in the following table.

FDA Enforcement of Regulatory Requirements for Categories of LDTs—Time Frames

Device Category

Notification or Registration and Listing/ Adverse Event Reporting Requirements

Premarket Review Requirements

Quality System Regulation Requirements

Low-risk devices, traditional LDTs, and LDTs for rare disease and unmet needs

Enforcement discretion.

Enforcement discretion.

Enforcement discretion.

Moderate-risk devices

Six months after guidance is finalized.

Phased-in enforcement will begin five years after guidance is finalized. FDA plans to announce priority list for class II within four years of finalized guidance.

Enforced once FDA issues a clearance order.

High-risk devices

Six months after guidance is finalized.

Phased-in enforcement will begin 12 months after guidance is finalized. FDA plans to announce priority list within 24 months of finalized guidance.

Enforced once premarket approval application is submitted.

FDA’s notification on the LDT guidance can be accessed here. Additional analyses of the impact of the new regulatory framework for LDTs, FDA’s guidance on in vitro companion diagnostics, and FDA’s actions focusing on personalized medicine will be forthcoming from Morgan Lewis.

Copyright © 2022 by Morgan, Lewis & Bockius LLP. All Rights Reserved.National Law Review, Volume IV, Number 212
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About this Author

Elizabeth Bierman, Regulatory and compliance lawyer, Morgan Lewis
Senior Counsel

M. Elizabeth Bierman represents US and international companies in US Food and Drug Administration (FDA) and state regulatory matters that impact the development, manufacturing, and marketing of their products. Beth has more 25 years of experience representing companies that produce a range of products regulated by the FDA, including medical devices, digital health products and mobile medical applications, tissue products, combination products, pharmaceuticals, medical foods, and infant formulas. She also provides guidance on related jurisdictional issues and regulatory...

202-739-5206
Phoebe Mounts, Food and drug attorney, Morgan Lewis
Partner

Phoebe Mounts counsels companies developing drugs, biologics, medical devices, and human cell and tissue-based products on US Food and Drug Administration (FDA) regulations. Her scientific background enables her to assist clients with product approvals for emerging technologies, such as combination products and companion diagnostics, including counseling on regulatory pathway issues and developing preclinical and clinical studies. Phoebe prepares submissions to the FDA, including applications for orphan-drug designation, humanitarian device exemptions (HDEs),...

202-739-5898
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