US FDA this week backed away from proposals to directly regulate Lab Developed Tests, signalling an increased caution ahead of the new administration. But FDA has also said it intends to bring forward further proposals soon – and what does this mean for manufacturers seeking to market tests through LDT?
As widely reported this week, US FDA has advised House and Senate committees that it no longer intends to issue a final LDT guidance. This was met with approval from the lab industry and mixed responses from manufacturers.
It remains to be seen what FDA will do next, although the agency indicated in a press statement that it intends to bring forward further proposals saying “we plan to outline our view of an appropriate risk-based approach in the near future”.
One thing is clear, the FDA remains firmly of the view that it regards manufacturers supporting labs to develop and validate commercially supplied kits as being outside the intent of LDT regulatory exemptions. In particular FDA takes a dim view of manufacturers offering RUO kits to labs and then supporting the lab to validate for clinical use. FDA stated some time ago that it considers such activities to be inconsistent with regulations and tantamount to supply of a commercial IVD requiring regulatory approval. That position has not changed with this latest news and test developers need to be careful.
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