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As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
Two years after its repeal of a rule that would have expedited Medicare coverage for FDA-cleared Breakthrough Devices, CMA Thursday issued a request for comment on a process to provide “transitional coverage for emerging technologies” (TCET). Read More
Over the past week, the FDA issued final guidance on oncology drug products used with certain in vitro diagnostic tests and draft guidance on formal dispute resolution and administrative hearings procedures. Read More
Vitang Technology, a Tustin, Calif.-based manufacturer of 3D printed dental alignment devices, failed to seek the FDA’s clearance when it changed the software used with its UniSmile Clear Aligner, the agency said in a June 12 warning letter to the company. Read More
Following multiple years of development, the streamlined version of the ClinicalTrials.gov website officially launched Wednesday, providing users with a revised, simplified layout intended to enhance efficiency and usability. Read More
After five years of development, a program to help devicemakers improve and accelerate their corrective and preventive action (CAPA) programs is ready to implement but its creators worry the industry will not be ready to adopt the model. Read More
Upcoming events in the coming weeks include three FDA advisory committee meetings as well as webinars on the FDA’s sterilization pilot and design control. Read More
Companies might receive a documentation observation even though the CAPA procedures and defined process are fully compliant because of deficient documentation. Read More