medical devices

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The FDA has published a draft guidance to clarify its requirements and review practices in connection with medical device applications submitted under its Humanitarian Device Exemption (HDE)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

In an effort to harmonize its medical device quality management system regulations with globally-accepted...

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.

Time and time again the one process that nearly always presents the most challenges to medical device companies, regardless of shape and size, is Corrective Action & Preventive Action (CAPA). This article explores those challenges and provides the reader with best practices and ways to improve the CAPA process and approach.

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

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance intended to clarify its policy regarding the assessment of medical devices offering multiple functions.

The FDA has released a draft guidance that may help reduce the burden on device manufacturers seeking to demonstrate substantial equivalence for some types of new medical devices.

The U.S. Food and Drug Administration (FDA) has warned the manufacturers of duodenoscopes of their obligation to conduct post-market surveillance studies to assess the effectiveness of post-use decontamination protocols.