FDA Issued a Guidance on Laboratory Developed Tests for Small Entity Compliance

On June 24, 2024, the U.S. Food and Drug Administration (FDA) issued a Small Entity Compliance Guide (SECG) to assist small entities in complying with FDA regulations as they apply to in vitro diagnostic (IVD) products, including laboratory developed tests (LDTs).

The LDT final rule published on May 6, 2024, amends the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA finalized a policy under which the FDA will phase out its general enforcement discretion approach for LDTs over the course of four years so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs. The phaseout includes targeted enforcement discretion policies for specific categories of IVDs manufactured by laboratories.

 The SECG is intended to help small entities understand and align according to the LDT final rule, including the:

• Scope and applicability of the LDT final rule.
• Timing and compliance expectations of the phaseout policy.
• Regulatory requirements related to:
  • Complaints, medical device reports, and correction and removal reports
  • Registration and product listing
  • Device labeling
  • Investigational use
  • Quality system
  • Premarket review

May 6, 2025 is the first phaseout date for LTD manufacturers to be fully compliant with the medical device reporting, reporting of corrections and removals, and complaint files per 21 CFR 820.198.

‍