The announcement was welcomed by most organizations that represent the interests of clinical labs, because there was a lot in the agency’s draft guidance, originally issued in 2014, which they didn’t like. In particular, the clinical lab industry was concerned that the FDA seemed to be leaning toward ruling that the development of new LDTs would have to follow the customary FDA premarket process for determining level of risk. The FDA would consider them “medical devices” like any other such devices that come under its purview. The idea of the agency applying regulations intended for medical device manufacturers to LDT creators could cast a chilling effect on LDT development. The fact is: LDTs are not medical devices.
Now, a new development. According to a January 26 posting on the FDA Law blog, the agency, “in an effort to document the work that it had done and further the public discussion regarding LDTs,” issued a “discussion paper” on January 13, setting forth key points that might be part of a future framework for regulating LDTs. As the FDA Law bloggers point out, this was released a week before the end of the Obama administration, and was not a formal document anyway, but it is still worth looking at. Some components could still be part of future regulation.
The discussion paper says, “There is a growing consensus that additional oversight of LDTs is necessary, as reflected in several recent oversight proposals put forward by some organizations representing laboratories and the IVD industry.” It summarizes what its authors see as “features” those proposals “generally share.”
- A risk-based approach to oversight
- Independent premarket review for certain tests and for some modified tests
- A focus on analytical and clinical validity as the basis for test approval
- Risk classification activities
- Adverse event reporting
- Exemption of certain categories of tests from premarket review
- A robust laboratory quality system
- “Grandfathering” for tests available prior to a specific date
- Public availability of test performance information.
The document continues: “These proposals differ with respect to which federal agency would be responsible for any additional oversight: FDA, the Clinical Laboratory Improvement Amendments (CLIA) program, which is overseen by the Centers for Medicare and Medicaid Services (CMS), or a hybrid model under which FDA and CMS engage in complementary, non-duplicative oversight have been proposed….Based on the feedback we have received, the complementary approach in some form is supported by the broadest array of stakeholders, including some members of the laboratory community.” (Indeed, that was a key component of some testimony by industry leaders who rightly fear duplicative regulation—it’s good to see that the FDA heard.)
A bit later in the discussion paper: “Based on this extensive feedback, several alternatives to what FDA proposed in 2014 should be considered, including:
- Exempting LDTs already on the market from all FDA oversight except for adverse event and malfunction reporting (“grandfathering”), and exempting traditional LDTs and LDTs for public health surveillance from all oversight
- Not adopting proposals requesting laboratories to notify FDA of their LDTs on the market because FDA generally would no longer need to classify LDTs currently on the market as the result of “grandfathering”
- Providing additional time before FDA would begin actively overseeing certain regulatory requirements
- Shortening the overall phased-in timeframe.
Will the FDA under the new administration continue along those lines, or take other approaches, or back away from LDT regulation altogether? How burdensome will compliance be? Once the new FDA commissioner is in place, the new direction may become more clear.