AdvaMed and MDMA, two rivaling lobby groups, have again come together against a common enemy: the Obamacare medical device excise tax. The groups simultaneously released survey results that argue that permanently repealing the tax would be a boon for their member companies and innovation.
Two of the most powerful medical device lobby groups have launched what seems to be a coordinated attack in their war against the 2.3%medical device excise tax. This comes only days after a bill was reintroduced in the US House of Representatives to permanently repeal the tax.
AdvaMed and the Medical Device Manufacturers Association (MDMA) simultaneously emailed results from respective industry surveys arguing that the temporary suspension...
The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.
Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.
Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.
Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.
The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
