After years of debate, the FDA has finalised its rule on the regulation of laboratory developed tests (LDTs). This landmark decision will have significant implications for the medical diagnostics industry, as the agency transitions from its historical enforcement discretion approach.
The final rule outlines a 4-year phaseout period, during which the FDA will gradually impose regulatory requirements on LDTs. This phased implementation is designed to give laboratories sufficient time to adapt to the new framework without disrupting critical diagnostic services.
The phaseout will occur across 5 distinct stages:
Stage 1 (1 year after publication): Compliance with medical device reporting (MDR),correction/removal reporting, and quality system requirements for complaintfiles.
Stage 2 (2 years): Compliance with registration/listing, labelling, and investigational use requirements.
Stage 3 (3 years): Compliance with the remaining quality system regulation requirements, excluding the complaint file provisions.
Stage 4 (3.5 years): Compliance with premarket review for high-risk LDTs (class III or subject to PHS Act licensure) unless a premarket submission has already been received.
Stage 5 (4 years): Compliance with premarket review for moderate and low-risk LDTs requiring premarket submissions unless a submission has already been received.
Notably, the FDA has stated that LDTs are, and have always been, considered illegal devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Theagency's historical enforcement discretion approach is now being phased out, making compliance with applicable regulatory requirements mandatory.
While the final rule provides a structured transition, it has not been without controversy. The FDA's claims of revisionist history regarding its oversight ofLDTs since 1976 have been met with scepticism. Additionally, legal challenges from laboratory associations and individual laboratories are anticipated, potentially seeking to block or delay the implementation of the rule.
Navigating this complex regulatory landscape will be crucial for LDT manufacturers and laboratories. Engaging early with the FDA, understanding the specific requirements for your device's risk classification, and ensuring timely compliance will be essential to avoid potential enforcement actions.
As the medical diagnostics industry prepares for this significant shift, staying informed and proactive will be key to maintaining patient access to critical laboratory-developed tests.
At PeploBio, our team of regulatory experts is here to support you through this transition. We can provide tailored guidance on navigating the FDA's new LDT regulations, ensuring your products meet the necessary requirements, and developing a robust compliance strategy. Contact us today to learn how we can help your organisation stay ahead of the curve.