When it comes to changing a medical device, one of the most important decisions can involve whether to log it in as an internal letter-to-file or submit a special 510(k) or PMA supplement with FDA. In many cases, company officials don’t do some initial investigation before making the decision, according to Vascular Sciences President Michael Drues, who has […]
FDA will start issuing early warnings about medical devices that may be causing adverse events, under a final guidance for industry and FDA staff released this week. The plan for the agency to publicly disclose emerging safety signals drew fire from industry groups earlier this year. AdvaMed, for example, said in its public comment to […]
(Reuters) – Shares of many U.S. companies that produce prescription medicines have been under pressure this year, but the picture has been rosier for makers of pacemakers, knee replacements and other medical devices. While biotechnology and specialty pharmaceutical companies endure scrutiny over drug costs, medical device companies have avoided that glare. Their sterling first-quarter results […]
On the eve of its 10th anniversary, New York medical device industry council MedTech released a report touting the strength of the state’s bio/med base and the benefits it confers on the economy.
House Rep. Dan Maffei (D-N.Y.) this week introduced a new bill that seeks to repeal the 2.3% medical device tax, making up for the $30 billion in lost revenue by cutting tax breaks for big oil and gas companies.
The proposed pay-for may to be more popular with Democrats, who previously balked at attempts to recoup lost tax revenue by taking a stronger hand in reclaiming over-paid health insurance tax credits granted to families.