Both Democratic and Republican staffers on key congressional health committees say that members pushing forward a Senate “medical innovation” bill and backing “Cures” legislation in the House will not interfere with FDA’s proposed plan to regulate laboratory developed tests before the guidance is made final.
Capitol Hill staffers are signaling that Congress will not interfere with FDA’s plan to further regulate clinical laboratories via its proposed lab-developed test guidance in the short-term, despite some heavy opposition lobbying from the laboratory industry and various alternative regulatory schemes for diagnostics being floated to lawmakers.
Even before FDA proposed its LDT framework
Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.
Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.
The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
