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.

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.