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Negotiations continue to move forward for the fourth installment of the Medical Device User Fee Act, with FDA and industry representatives focusing attention on improving performance of the review process. Read More
The FDA has given its final word on how sponsors of implantable minimally invasive glaucoma surgical devices should conduct clinical and nonclinical studies to support a premarket approval. Read More
Colombia’s Instituta Nacional de Vigilancia de Medicamentos y Alimentos has updated regulations governing the sanitary requirements related to laboratories developing external orthopedic prosthetics and orthotics. Read More
The drumbeat for the removal of Bayer’s controversial implantable contraceptive device Essure is growing louder, with a federal lawmaker becoming the latest to urge the FDA to take it off the market until a well-designed study can demonstrate its safety and effectiveness. Read More
Vericel has submitted a humanitarian device exemption supplement to the FDA to revise the labeled indications of Epicel to specifically include use in pediatric patients. Read More
The FDA has issued new guidance clarifying the processing and technical standards for electronic copies for medical device submissions, based on the agency’s experience so far with the program. Read More
The FDA is reopening the comment period for feedback on challenges and opportunities of regulating next-generation sequencing-based clinical tests, responding to requests from stakeholders who need additional time to submit input. Read More
Australia’s Therapeutic Goods Administration has revised its guideline on how manufacturers should classify in vitro diagnostics based on risk. Read More