The quinquennial user fee process for medical devices has always proven controversial, but the FDA and industry have missed a Jan. 15 deadline for an agreement to be presented to Congress. Recently, several members of the House and Senate inked a letter to the FDA about the missed deadline, a signal that the agency’s aspirations for a $2.5 billion user fee deal are in jeopardy.
The semiconductor industry has been hit hard by shortages of computer central processing units (CPUs) in recent months, but the persistence of these shortages has prompted a new response from industry. The Advanced Medical Technology Association (AdvaMed) said device makers are taking steps to ease the crunch, but that the Biden administration must take steps to ensure that medical technologies do not suffer from shortages, given the critical role played by devices in patient care.
The FDA’s device center has published two guidances dealing with patient engagement in relation to the conduct of clinical trials, including a final guidance for patient input into clinical trial design. The final guidance is mum, however, as to whether consultations with patient representatives constitutes a violation of the Anti-Kickback Statute (AKS), a predicament the Advanced Medical Technology Association (AdvaMed) said may represent a serious legal hazard for device makers.
Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) have reintroduced Cures 2.0, legislation they said will increase access to live-saving cures and treatments for a variety of diseases such as Alzheimer’s disease.
The U.S. Centers for Medicare & Medicaid Services (CMS) finally laid to rest the rule for Medicare Coverage of Innovative Technology (MCIT), a policy proposal that found favor with industry and with several patient groups. However, the news comes shortly after a bipartisan group of 10 senators had penned a letter to the agency to reissue the rule, reinforcing the prospect that the MCIT proposal will find widespread support in the halls of Congress in 2022.
The U.S. Centers for Medicare & Medicaid Services (CMS) has withdrawn the proposal to provide automatic Medicare coverage of FDA breakthrough devices, but the proposal may not be as dead as it once seemed.
The U.S. CMS waded into controversy with two final rules calendar year 2022, drawing fire from device makers and doctors who allege that cuts in rates for physicians will hamper beneficiary access. Software developers working in the telehealth space will find much to cheer, however, given that some telehealth services that were covered during the COVID-19 pandemic will be covered after the pandemic has passed.
The U.S. Centers for Medicare & Medicaid Services’ (CMS) withdrawal of a proposal to provide automatic coverage of FDA-designated breakthrough devices has drawn criticism from device makers, but the industrial reaction runs the gamut.
The shortage of European notified bodies (NBs) for in vitro diagnostics has prompted calls from industry to delay the compliance dates for the In Vitro Diagnostic Regulation (IVDR), and the European Commission has responded with a proposed fix. The Commission proposed to give IVDs that are already on the market until May 2025 or later to obtain new CE marks, but the change requires the assent of the European Parliament and the European Council before it goes into force.
The FDA’s final rule for the de novo petition process took nearly three years to wrap up, a timeline likely extended by the COVID-19 pandemic, but the final rule retains some controversial features seen in the 2018 draft. Among these is a provision for FDA inspections before determining whether to grant the petition, a provision that was blasted by multiple commenters as extra-statutory and a needless source of drag on these applications.
