Wellness Draft Guidance Does Its Job, Industry Group Says
This article was originally published in The Gray Sheet
The decision algorithm and flexible approach in FDA's recent draft guidance will support innovate mobile health development, an industry advocate says.
You may also be interested in...
Multiple guidances, frameworks and legislative activity on mHealth are expected to surface this fall and could have major implications on how the emerging industry is regulated.
The ball is now in the federal government’s and state insurance commissioners’ courts to enforce a district court ruling after HHS stops its appeal. As groups that brought the suit press CMS for guidance, they also eye complaints with DOL and class-action suits.
The US agency is warning manufacturers about an alarming device submission trend toward unreliable data generated by third-party labs.