Regulatory and Legal
Consumer Reports' Advocacy Arm Calls for Improved Medical Device Safety
Feb 07, 2012
Pressure continues to build on Congress to introduce more stringent regulation of medical devices. "Innovation should not trump safety," says the...
FDA on Free Speech and How to Respond to Tweets
Feb 06, 2012
In December, FDA released a draft document titled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical...
Members of Congress Introduce Legislation To Close Loophole In Medical Device Approval Process
Feb 03, 2012
Reps. Edward J. Markey (D-Mass.), Henry A. Waxman (D-Calif.), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.) announced in a press release that they have...
Senators Introduce Legislation to Remove Regulations Slowing Innovation for Medical Device Manufacturers
Feb 03, 2012
Senators Bob Casey (D-PA) and John McCain (R-AZ) announced in a press release that they have introduced legislation to remove burdensome regulations that hurt...
IRS Moves Forward with Plans to Implement Medical Device Tax
Feb 03, 2012
UPDATE: On February 6, 2012, Todd Rokita (R-IN) sent a letter to House leadership asking for the medical device tax to be repealed.  The IRS has recently...
Senators Welcome FDA Medical Device User Fee Agreement
Feb 02, 2012
Senators Tom Harkin (D-IA) and Mike Enzi (R-WY), the Chairman and Ranking Member of the Senate Committee on Health, Education, Labor and Pensions (HELP),...
FDA, Medical Device Industry Reach Agreement in Principle on Medical Device User Fees
Feb 01, 2012
FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a...
FDA Releases 2012 Medical Device Priorities
Jan 31, 2012
FDA's Center for Devices & Radiological Health has announced its strategic medical device priorities for 2012. The device center said it will focus on the...
CDRH Ombudsman Reports on Complaints
Jan 30, 2012
The ombudsman of FDA's Center for Devices and Radiological Health reported that it had 461 contacts with the public in 2011, up 11% from the previous year....
What You Should Know about Patent Reform: The Post-Grant Review Process
Jan 22, 2012
MD+DI: Could you explain the post-grant patent review process?   David Dykeman is a patent attorney and co-chair of the IP department at...