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While prescription drug user fees increased a hefty 19.9 percent and medical device fees a modest 8.7, fees for biosimilar applications dropped up to an eye-popping 373 percent. Read More
Recommendations for study design to facilitate innovation in development of devices, such as deep brain, transcranial magnetic and spinal cord stimulations, intended to treat opioid use disorder (OUD) are the subject of a draft guidance issued July 27. Read More
More than 20 billion devices are sterilized with EtO each year, CDRH says, representing about 50 percent of devices that require sterilization. Read More
AdvaMed and Deloitte have updated their 2017 report on assessing the value of diagnostic technologies by incorporating a look at how the shift of risk from payer to provider will affect the adoption of new medtech innovations — while at the same time, reducing cost, improving patient experience, outcomes and satisfaction. Read More
Helping consumers avoid adverse events from improper use of hydrogen peroxide-based contact lens care products (HPCP) by improving labeling is the aim of a final guidance the FDA released Wednesday. 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