Standards by Topic

The U.S. Food and Drug Administration (FDA) has published a final rule that brings...

The U.S. Food and Drug Administration (FDA) has issued a series of recommendations for...

The U.S. Food and Drug Administration (FDA) has published a draft guidance intended to...

The U.S. Food and Drug Administration (FDA) is seeking public comment on a proposed...

The U.S. Food and Drug Administration (FDA) is seeking public comment on an updated version of its proposed pilot program to speed the approval of software used in digital health applications.

The FDA has published a draft guidance to clarify its requirements and review practices in connection with medical device applications submitted under its Humanitarian Device Exemption (HDE) Program.

The FDA has issued a Final Order that exempts certain Class II medical devices from the agency’s premarket notification (510(k)) requirements.

The FDA has published an updated list of recognized consensus standards that can used in support of premarket medical device reviews conducted by the agency.

This article focuses on medical electrical devices and three countries/regions of the world, the U.S., Canada and the European Union (EU). There are a lot of regulatory, quality system and standards changes happening in the medical device space in the last couple years and these will continue in the years ahead.

The International Medical Device Regulators Forum has recently issued drafts of two separate guidance documents that may be of interest to medical device manufacturers.