Quality Requirements and Standards

While uncertainty over LDT regulation grows, remember that if nothing happens in DC, the LDT policy is _on_the_books. If the court doesn't overturn it, or some wildly specific executive order delay or destroy it, it's going to happen. These LDT dates should be on your schedule:

• Stage 1: [Let the Complaining Begin!]
  beginning on May 6, 2025, which is 1 year after the publication date of the final LDT rule, FDA will expect compliance with medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements regarding complaint files.
• Stage 2: [Registration, Listing, Labeling, what fun!]
  beginning on May 6, 2026, which is 2 years after the publication date of the final LDT rule, FDA will expect compliance with requirements not covered during other stages of the phaseout policy, including registration and listing requirements, labeling requirements, and investigational use requirements.
• Stage 3: [Quality Systems Infinity!]
  beginning on May 6, 2027, which is 3 years after the publication date of the final LDT rule, FDA will expect compliance with QS requirements (other than requirements regarding complaint files which are already addressed in stage 1).
• Stage 4: [Premarket Review for High-Risk IVDs, prepare to spend!]
  beginning on November 6, 2027, which is 3½ years after the publication date of the final LDT rule, FDA will expect compliance with premarket review requirements for high-risk IVDs offered as LDTs (IVDs that may be classified into class III or that are subject to licensure under section 351 of the Public Health Service Act), unless a premarket submission has been received by the beginning of this stage in which case FDA intends to continue to exercise enforcement discretion for the pendency of its review.
• Stage 5: [Premarket review for moderate & low-risk IVDs, do you have any money left? Now you don't!]
  beginning on May 6, 2028, which is 4 years after the publication date of the final LDT rule, FDA will expect compliance with premarket review requirements for moderate-risk and low-risk IVDs offered as LDTs (that require premarket submissions), unless a premarket submission has been received by the beginning of this stage in which case FDA intends to continue to exercise enforcement discretion for the pendency of its review.