Federal Register notice: FDA makes available a draft guidance for industry entitled Type V DMFs for CDER-Led Combination Products Using Device Constit...
Federal Register notice: FDA classifies self-fitting air-conduction hearing aids into Class 2 (special controls).
Federal Register notice: FDA posts a list of FDA information collections recently approved by OMB.
FDA updates a 2018 safety alert about Endologixs AFX endovascular graft systems used in treating abdominal aortic aneurysms and the risks associated w...
Federal Register notice: FDA announces an 11/21 public meeting seeking input on a report to Congress about pediatric study requirements.
Federal Register notice: FDA seeks comments on an information collection extension entitled Planning for the Effects of High Absenteeism To Ensure Ava...
FDA posts a draft guidance on Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics or Software.
FDA releases a fact sheet to explain its Accreditation Scheme For Conformity Assessment (ASCA) Pilot Program: Draft Guidance.