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In 2017, the agency approved 66 devices through the premarket approval and humanitarian device exemption pathways but only 18 of those were indicated for use in a pediatric population. Read More
In preparation, the department analyzed supply chains for medical devices and clinical consumables to determine the proportion of products that are routinely imported. Read More
The agency said it would consider the target patient population, size, intended use and current treatment options in assessing devices for the HDE program. Read More
Manufacturers must make eIFUs available on their websites easy to navigate and search and not require users to create an account to access them, the agency said. Read More
A litany of major GMP deficiencies — ranging from inadequate document control procedures, CAPA, device acceptance procedures and procedures to control product — plagued GEM City Engineering and Manufacturing during a Feb. 21 to March 1 FDA inspection of its Dayton, Ohio facility. Read More
FDA Commissioner Scott Gottlieb said the agency wants to encourage the development of medical devices designed specifically for pediatric patients and noted “there are still far too few devices on the market designed specifically to treat, diagnose, or cure diseases in children.” Read More
The FDA issued a list of medical device accessories that it believes are safe and effective enough to be categorized as Class I and requested public feedback on the proposed list. Read More