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Upcoming events in the coming weeks include six FDA advisory committee meetings as well as the GMP Quality Management vSummit, and webinars from FDAnews, a WCG company on reliability assessment and medical device risk management tools. Read More
Drug-device combination products can pose cumbersome regulatory challenges for companies, say regulatory experts, primarily because the product has to comply with two complicated regulatory systems that are not designed to work together. Read More
Recalls can be messy, complicated matters, especially for manufacturers that don’t have a plan in place for analyzing a problem, determining a course of action and carrying out all recall-related tasks in compliance with FDA requirements. Read More
CDRH has recognized low temperature vaporized hydrogen peroxide as an alternative to ethylene oxide (EtO) for medical device sterilization and is updating its reference documentation to assist manufacturers in making changes to sterilization procedures. Read More
The FTC and HHS have teamed up on a campaign about the privacy and security risks associated with online tracking technologies integrated into mobile health apps and websites with a letter to 130 hospital systems and telehealth providers. Read More
BD has received 510(k) clearance for both remediation and return to full commercial operations of its updated Alaris infusion pump system, which was subject to an FDA class I recall in 2020, the most serious type of recall as use of the device may lead to serious injury or death. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
The Senate Health, Education, Labor and Pensions (HELP) Committee has advanced reauthorization of the 2006 Pandemic and All Hazards Preparedness Act (PAHPA), allowing the FDA to require that manufacturers notify the agency of potential product shortages when there’s no public health emergency (PHE). Read More
A regulatory affairs specialist for an eastern Pennsylvania medical device company has pled guilty to fabricating documents on FDA letterhead representing that two of his company’s products had received 510(k) clearances when, in fact, he had never made any submissions for the devices. Read More