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Inside FDA's Proposed Rule to Regulate LDTs

Key Questions Labs Should Consider Now

In Fall of 2023, the FDA proposed a rule to end its enforcement discretion policy for laboratory-developed tests (LDTs) by treating them as In Vitro Diagnostics (IVDs) subject to regulatory requirements as medical devices.

The FDA wasted no time updating its Unified Agenda to indicate that a final rule may be published as soon as April 2024.

While it remains to be seen if the FDA can hit this date, we thought it’s worth presenting the preliminary questions impacted labs will need to consider if they have only a year to hit the Stage 1 requirements once that final rule is issued: Begin filing medical device reports (MDR) under 21 C.F.R. Part 803 and notices of correction and removal under 21 C.F.R. Part 806.

To conduct a high-level gap analysis and understand the work projects involved in hitting this milestone, we’ve identified 22 questions labs will need to consider in areas such as:

• Reporting Mechanisms
• Event Categorization
• Staff Awareness and Training
• Documentation and Record-Keeping
• Quality and Timeliness of Reports
• Identification of Corrections and Removals
• Decision-Making Process
• Communication Protocols
• Documentation Standards

Download the free guide to reveal all the questions labs should be considering now to prepare for a possible end to discretion enforcement of LDTs.