A color additive evaluation tool for polymeric medical devices was approved as an MDDT under the FDA’s voluntary program.
A color additive risk emulation tool named CHRIS (CHemical RISk calculator) has gained new Medical Device Development Tool (MDDT) designation through a voluntary program of the US Food and Drug Administration.
CHRIS is a non-clinical assessment model that helps medical device manufacturers address the biocompatibility of color additives in polymeric medical...
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The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
