Manufacturers of low-risk class I products were given an extra two years to comply with FDA's Unique Device Identification requirements to give the agency and industry time to work through challenges posed by incorporating device identifiers into electronic health systems.
Makers of low-risk class I devices have an extra two years of wiggle room to comply with US FDA's Unique Device Identification program thanks to a deadline extension from the agency.
Class I device and unclassified product manufacturers originally had until September 2018 to add UDI to labels, but according to...
Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?
The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.
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The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
