Senate passes budget amendment to repeal device tax
Senate votes 79-20 in favor of medical device tax repeal amendment.
FDA to Amend BIMO Device Regulations- More or Less Burden on Sponsors?
FDA recently published a new proposed rule in the Federal Register that will be open to comments until May 28th, 2013. The rule proposes an amendment to the regulations at 21 CFR Parts 807, 812, and 814 pertaining to the acceptability of data collected inside and outside of the U.S. that will be used to support a marketing application (IDE, 510(k), PMA, etc.). Surprisingly, the regulations currently do not fully address the requirements for either.
Re-evaluation of the FDA Premarket Review Program
Concerns brought up by the medical device industry, consumer groups, health plans, health care providers and employees of the FDA created a need for re-evaluating the process for receiving and reviewing medical device approvals. Problems that became apparent included: uncertainty of requirements, lengthy reviews, and mid-process changes that left things unpredictable.
Telehealth; The use of Telecommunication Systems health monitoring
A bill has been proposed to the House of Representatives, in December of 2012, proposes the expansion of the use of health care through telecommunication systems.
Response received from Mark Udall, U.S. Senator, Colorado re: Medical Device Excise Tax dated 1 MAR 2013
Senator Udall takes the time to respond to a Colorado voter on the must debated Medical Device Excise Tax. Read about his comments in this weekly BLOG.
Legislator – FDA Should Create New Office to Regulate Mobile Apps (Additional Information)
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.
Tell your Members of Congress to Support Repeal of the Medical Device Excise Tax
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.
Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices
21 CFR Parts 807, 812, and 814; DEPARTMENT OF HEALTH AND HUMAN SERVICES; FDA; Docket No. FDA-2013-N-0080; ACTION: Proposed rule.
Potential Effects of Extreme Weather/Natural Disasters on Medical Devices
Device Good Manufacturing Practice Advisory Committee; Notice of Meeting;
DEPARTMENT OF HEALTH AND HUMAN SERVICES; FDA; Docket No. FDA-2013-N-0001; ACTION: Notice.
Kids Have Problems With Medical Products?
Consumers can play a critical role in helping the Food and Drug Administration (FDA) assure children’s access to safe medical products.