The FDA has reissued a 2017 draft guidance for clinical decision support (CDS) applications as part of a reexamination of software regulations, and one difference between the 2017 draft and the latest iteration that is sure to cheer developers is that the agency now provides much more clarity as to the types of functions that will and will not fall under regulatory scrutiny going forward.

BOSTON – The 2019 Medtech Conference included the annual FDA town hall session, and Jeff Shuren, director of the agency's device center, said the pace of scientific change is outstripping the agency's ability to keep up. Shuren said the solution might be "regulatory Legos," an approach that might eliminate the need to go to Congress for new statutory authorities every time device makers carve open a new technological frontier.

BOSTON – The FDA's Center for Device and Radiological Health (CDRH) released draft guidance on Monday aimed at encouraging the use of patient input in medical device clinical trials and helping sponsors understand how they can use patient engagement to improve the design and conduct of investigations.

BOGOTA, Colombia – Last month, Anvisa, Brazil's health surveillance agency, approved a proposal that makes it mandatory for the agency to monitor the prices of medical implants, a category that, in Brazil, includes orthoses, prostheses and special materials. Is this the beginning of a price capping era for medical devices in the Latin American giant?