On April 29, 2024, the FDA announced a final rule that amends the FDA regulations to bring laboratory developed tests (LDTs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
While much of the industry scrambles to understand the implications, manufacturers will find the new rule provides a significant opportunity for LDT device providers to jump ahead of their competition and gain market share by rapidly complying with the new regulations and at the same time improving the quality of their product offerings.
Background
The FDA has brought LDT’s under the FD&C act because their expanded use exposes the public to greater risk than their original use intended. LDTs, a type of IVD, were originally intended to be designed, manufactured in small volumes, and used within a single clinical laboratory. They were intended for lower risk diagnostics, performed in small volumes, using manual techniques and performed by well-trained laboratory personnel. The intended use of LDTs, however, has changed over time.
In vitro diagnostic (IVD) products are intended for use in the collection, preparation, and examination of specimens taken from the human body (blood, saliva, etc.). The FDA treats IVD’s as medical devices and regulates their design, manufacture and use accordingly. CMS (Centers for Medicare & Medicaid Services) on the other hand, has governed the design, manufacture and use of LDTs via the less stringent Clinial Laboratory Improvement Amendments (CLIA) regulations. While the FDA could enforce FD&C regulations for LDT’s, historically it has not done so because LDTs have presented lower safety risk.
The clinical risk involved with most LDT systems is much greater now than decades ago due to changes in intended use. At present, LDTs are used widely in large laboratories which increasingly rely on high-tech instrumentation and software. Tests are typically performed in large volumes. LDTs are used more frequently to help guide critical health care decisions. Manufacturers have offered IVDs as “LDTs” even when they are not LDTs as defined by the FDA, because they were not actually designed, manufactured, and used within a single laboratory. Consequently, to manage the increased safety risk, the FDA has decided to regulate the design, manufacture and use of LDTs with the same rigor as a medical device.
Phaseout Policy
The FDA is phasing out its general enforcement discretion approach to LDTs so that LDTs will generally fall under the same enforcement approach as other IVDs.
Adherence to these new standards will require manufacturers to look in greater detail at their development processes and deliverables. In the first stage of the phaseout, systems will need to be in place to track, report and correct medical device reporting (MDR) complaints. MDR regulations open up LDT manufacturers to deploy corrections or removals (recalls) of fielded devices, which is something new to LDT manufacturers. Robust risk management processes will be needed to properly evaluate the safety impact of MDR complaints. Configuration management of development deliverables and fielded LDTs will also be important to support development and MDR corrections. Labelling will be important to support safe and effective use of the LDTs. Manufacturers will need to become proficient in premarket review submissions.
There will be a 4-year phaseout as described in this table taken from the FDA standard.
| Stage |
Compliance Expectations |
Timeline |
| Stage 1 |
Medical device reporting, reporting of corrections and removals, and complaint files |
Beginning May 6, 2025 |
| Stage 2 |
Registration, listing, labeling, investigational use, and other applicable requirements that are not a part of Stages 1, 3, 4, or 5 |
Beginning May 6, 2026 |
| Stage 3 |
Quality system requirements not addressed in earlier stages |
Beginning May 6, 2027 |
| Stage 4 |
Premarket submission requirements for high-risk IVDs offered as LDTs |
Beginning November 6, 2027 |
| Stage 5 |
Premarket submission requirements for low- and moderate-risk IVDs offered as LDTs, unless exempt |
Beginning May 6, 2028 |
This phaseout policy includes enforcement discretion policies for 9 categories of LDTs that the FDA considers unlikely to pose significant risks or are conducted in circumstances that themselves will mitigate the risks. Some examples are:
- Currently marketed IVDs offered as LDTs
- Forensic tests
- LDTs for unmet needs.
This enforcement discretion may change in the future as the FDA says they may update any of these policies as circumstances warrant or if the circumstances that inform these policies change.
Opportunities
Manufacturers of LDTs in compliance with the new rules will have an advantage over their competitors in providing LDTs and consumables to laboratories who have outsourced LDT development. There is also an opportunity to provide LDTs for laboratories that may discontinue the use of their own LDTs and consumables because the cost of compliance is too high. By taking on some of the responsibility, manufacturers can ensure continued use, which delivers better patient outcomes and protects against a drop in consumable use.
Next Steps
Here are some next steps you can take to understand your situation regarding the new rules.
1. Perform assessments to determine if the new rule and the enforcement discretion policies apply to your:
- Current LDT products
- New LDT products planned in your roadmap or already in development
- Expected future customer needs for LDT features.
2. Perform compliance gap analysis between your current quality system and the expectations of the new rule. Areas to consider in the analysis are:
- Design controls
- Configuration management
- Tracking and reporting of complaints and adverse events
- Implementing device corrective measures
- Device registration and listing
- Device labelling
- Investigational use requirements
- Premarket review submissions.
Full Spectrum Can Help
Full Spectrum has extensive experience in helping customers bring medical systems to market. We have a depth of knowledge and experience in both the engineering and regulatory aspects of medical devices. We can help you by:
- Performing regulatory assessments of your current and future products and providing recommendations on actions to take
- Performing compliance gap assessments on your quality system
- Implementing improvements to your quality system and products
- Providing resources to fulfill any additional engineering capacity needs you may have.