At a 2-day meeting on July 19-20, 2010, to allow public comment on FDA oversight of laboratory-developed tests (LDTs), the FDA proposed increasing its regulatory oversight of LDTs, likely in a similar risk-based way as other medical devices are regulated.

A total of 69 speakers addressed the FDA, representing commercial and academic laboratories, test manufacturers, state and federal government agencies, professional organizations, patient advocacy groups, and private citizens. Hayes, Inc. presented comments during the Clinical Laboratory Challenges session and was the only health technology assessment company represented among the speakers.

Among the public comments, these key themes emerged:

1. Instituting FDA oversight and/or regulation would lead to unnecessary expense that could lead to the closing of some labs and stifle innovation since companies and labs would not want to face the FDA process.
2. CLIA is sufficient for oversight of LDTs – although it was pointed out that CLIA regulates labs while the FDA regulates tests.
3. The FDA moves too slowly and thus lives may be lost while critical tests go through the regulatory process. The FDA countered that H1N1 tests were approved within 24 hours during the outbreak in 2008.
4. Tests for rare conditions for which testing is unlikely to be profitable will be ignored. Several speakers suggested that incentives for “orphan diseases” could be put in place similar to “orphan drug” incentives.
5. Regulation should be phased in over several years with consideration given to grandfathering existing LDTs.
6. Evidence of clinical utility should not be necessary for approval. A number of speakers commented that this evidence only accumulates after the test is marketed and used in clinical practice.
7. Further stakeholder engagement is necessary to ensure a smooth transition.

The FDA will review all comments and draft a white paper later this year. The webcasts of the full 2-day meeting are available here.