Regulatory
AdvaMed Spends for Medtech Industry
According to financial filings, AdvaMed spent $385,000 in the first quarter of 2010 lobbying Congress on behalf of the medtech industry. The organization's efforts were spurred by several significant issues. The first is healthcare reform, which dominated headlines for months....
Shuren Lands at Next Stop on Regulatory Tour
Jeffrey Shuren made another stop on his regulatory tour yesterday to listen to concerned stakeholders at a town hall meeting in the Boston area. CDRH's director again said that the center will overhaul its approval procedures to spur innovation while protecting patient safety. Like...
Manufacturer Commits to FDA's Home Use Initiative
Kinetic Concepts Inc. says it will voluntarily submit labeling for its products in the home use device labeling repository on FDA's Web site. The company says it is the first manufacturer to commit to this process. In April 2010, FDA announced its "Medical Device Home Use...
FDA Issues Draft Guidance on Infusion Pumps
To combat the increase in infusion pump recalls, FDA has created the draft guidance "Total Product Life Cycle: Infusion Pumps—Premarket Notification [510(k)] Submissions." The agency says it had received more than 56,000 MDRs related to infusion pumps between...
PMA Voting Process to Change
FDA expert panels plan to change the way they review and discuss data during public hearings regarding medical devices being considered for premarket approval (PMA). Effective May 1, 2010, medical device advisory committees will vote on the safety, effectiveness, and risks versus...
FDA Requires Device Makers to Consider Kids
Think your PMA is complete? Better make sure it includes information about how your company's device affects kids. According to a release on FDA's Web site, the agency is implementing a requirement that manufacturers provide information in certain PMAs about pediatric patients who...
New ISO Standard for Safer Symbols
A new ISO standard proposes a methodology for the development and presentation of symbols related to medical devices which can be understood by a gloabl community. ISO 15223-2:2010, "Medical devices – Symbols to be used with medical device labels, labelling, and...
Did FDA Ignore Radiation Warnings?
The answer is yes, say agency scientists. Tomorrow's public meeting, which will last two days, will include a discussion on protecting patients from exposure to unnecessary radiation. According to the NYTimes, scientists plan on making their concerns known regarding how FDA ignored...
Boston Sci May Soon Resolve ICD Issue
Analysts say that Boston Scientific may have been hasty in stopping sales of its implantable heart rhythm devices. According to Reuters, the company pulled its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices after realizing that it had...
FDA Meets to Debate Glucose Meters
At a two-day meeting (March 16-17) to review self monitoring blood glucose (SMBG) meters, FDA officials and staff  sought input from medical experts, industry and patient advocates on ways to improve test results with the widely used devices. Approximately, 400 people...