US Rep. Mike Honda (D-CA) plans to reintroduce a measure in Congress that would seek to establish a new office at the US Food and Drug Administration (FDA) dedicated to the development and oversight of mobile health technologies.
As you may know, bipartisan legislation was introduced recently in both the U.S. House and Senate to repeal the medical device tax. President Obama’s State of the Union address highlighted the need for more manufacturing and high-tech job creation, and we all know that our industry can answer this challenge. To this end, we need your help in building momentum through co-sponsorship and other outreach activities.
21 CFR Parts 807, 812, and 814; DEPARTMENT OF HEALTH AND HUMAN SERVICES; FDA; Docket No. FDA-2013-N-0080; ACTION: Proposed rule.
Device Good Manufacturing Practice Advisory Committee; Notice of Meeting;
DEPARTMENT OF HEALTH AND HUMAN SERVICES; FDA; Docket No. FDA-2013-N-0001; ACTION: Notice.
Consumers can play a critical role in helping the Food and Drug Administration (FDA) assure children’s access to safe medical products.
US Legislator Proposes New Office to Regulate Mobile Apps
The FDA Premarket Approval Process for Medical Devices for commercial release within the United States
Section 201(h) of the Federal Food, Drug, and Cosmetic Act defines a medical device as “any instrument, machine, contrivance, or implant, in vitro reagent that’s intended to treat, cure, prevent, mitigate, and diagnose disease in man”.