We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA used a Q&A format to issue final guidance on an informal, non-binding process for sponsors to obtain preliminary feedback before submitting marketing applications. Read More
FDA Commissioner Scott Gottlieb offered a closer look at initiatives and investments the agency would pursue in support of novel medical technologies using new funding requested… Read More
The International Medical Device Regulators Forum released new guidance to help global regulators, conformity assessment bodies and industry assess whether a medical device conforms to regulations in each jurisdiction. Read More
The FDA issued “immediately in effect” guidance for manufacturers of Class I and unclassified medical devices on compliance dates for meeting unique device identification requirements. Read More
Health Canada pointed to the last paragraph in the Food and Drugs Act’s definition of a medical device as a significant 2014 addition intended to help distinguish between products. Read More