Bradley Merrill Thompson and James A. Boiani, Members of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, were quoted in Bloomberg BNA’s Medical Devices Law & Industry Report, in “House Committee Draft Bill Would Change Regulation of Diagnostic Tests,” by Michael D. Williamson.
Following is an excerpt:
The bill could lead to quicker approvals of lab tests, attorney James Boiani, with Epstein Becker and Green PC in Washington, told Bloomberg BNA June 12. Quicker approvals could spur innovation in the test industry, he said.
Thompson said the draft provides an opportunity to have a constructive discussion on how IVDs differ from devices. For years, the device industry has told the FDA not to treat it like the drug industry and now IVD makers are saying they don’t want the FDA to treat them like device makers, he said.
In addition, the draft bill offers an alternative to the FDA’s LDT draft guidance documents, he said. Those documents, Thompson said, gradually bring LDTs into the FDA’s oversight. The draft bill would sidestep the guidance issue, Thompson said, because all LDTs currently on the market would be exempt from the FDA’s oversight. …
Boiani said a lot of devices are implantables that touch the body and that tests are different. Thus, the types of risks involved with tests are different, he said. Having a separate center for IVDs “might be beneficial” because of these differences, Boiani said.