FDA plans to shift the classification of many high-risk In Vitro Diagnostics, simplifying their journey to approval

Laboratory-developed tests (LDTs), which are both crafted and utilized within a singular lab environment, have come under increased scrutiny in the past year. The FDA argues that the risks these tests pose have escalated since the agency initially decided to regulate them with a more hands-off approach.

FDA Commissioner Robert Califf has recently emphasized that tightening the regulatory framework around LDTs is a key agenda for the agency.

It's noteworthy that many clinical labs currently circumvent FDA oversight by categorizing their tests as LDTs, a practice that the FDA has repeatedly stated falls within its regulatory purview.

In updating the classification for a majority of In Vitro Diagnostics (IVDs) from the more rigorously reviewed class III to class II, it's important to recognize that this doesn't mean a reduction in scrutiny. Pre-market evaluations will still be a critical step, now under the 510(k) pathway.

The tests predominantly affected by this reclassification include those for infectious diseases and companion diagnostics, which are essential for determining the appropriate use of specific medications, as indicated by the agency.

Amid these changes, the FDA is actively pursuing enhanced regulatory measures for LDTs. despite pushback from various industry groups like the American Clinical Laboratory Association and the American Hospital Association.

Echoing these sentiments, former FDA Commissioner Scott Gottlieb highlighted at a Friend’s of Cancer Research forum that the FDA's decision to relax the diagnostic test classifications is aimed at easing the financial pressures on test developers, facilitating the implementation of the final rule on LDTs.

The discourse around the FDA's authority to regulate LDTs continues, with some analysts suggesting that legislative action may be necessary to clarify the FDA's jurisdiction in this area.

Furthermore, the FDA intends to maintain a risk-based strategy when initially classifying individual IVDs. This approach helps in determining the level of regulatory oversight needed and whether a test should be classified as class II through the de novo pathway, complete with specific controls, as opposed to being designated as a class III device, which would require pre-market approval.

‘From our collective experience, it's feasible to develop specific controls that, along with general controls, would ensure the safety and effectiveness of most upcoming companion diagnostic and infectious disease IVDs, thereby categorizing them as class II devices’, according to the FDA.

See the full meeting here.