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This rule would amend the Food and Drug Administration’s regulations to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act.)

Statement of Need:

In 1976, the Medical Device Amendments of 1976 (the MDA) amended the FD&C Act to create a comprehensive system for the regulation of devices intended for human use.  In implementing the MDA, FDA has generally exercised enforcement discretion such that it generally has not enforced applicable requirements with respect to most LDTs.  However, the risks associated with LDTs are much greater today than they were at the time of enactment of the MDA, and today’s LDTs are more similar to other in vitro diagnostic products (IVDs) that have not been under FDA’s general enforcement discretion approach.  This rulemaking would amend FDA’s regulations to reflect that the device definition in the FD&C Act does not differentiate between entities manufacturing the device.  In conjunction with this amendment, FDA is advancing a policy under which FDA intends to phase out its general enforcement discretion approach for LDTs, so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs.  This action is necessary to redress the imbalance in oversight of LDTs and other IVDs and to protect the public health by helping to assure the safety and effectiveness of LDTs.

Summary of the Legal Basis:

FDA is issuing this rule under the Agency’s general rulemaking authorities and statutory authorities relating to devices in the FD&C Act, including the definition of a device under section 201(h)(1) of the FD&C Act and FDA’s authority to issue regulations for the efficient enforcement of the FD&C Act under section 701(a) of the FD&C Act.

Alternatives:

The Agency has considered various options to protect the public health by helping to assure the safety and effectiveness of LDTs while avoiding undue disruption to the testing market.

Anticipated Costs and Benefits:

This rule would result in compliance costs for laboratories that are ensuring their IVDs are compliant with applicable statutory and regulatory requirements.  We anticipate that the benefits would include a reduction in healthcare costs associated with unsafe or ineffective tests, including tests promoted with false or misleading claims, and from therapeutic decisions based on the results of those tests.

Risks:

None.