Although CMS' newly finalized rule on accountable care organizations has allayed health care providers' fears of a program too burdensome to bother with, medical device manufacturers remain worried that ACOs will curb patient access to their products.
The Institute of Medicine committee charged with reviewing FDA's 510(k) device pre-market review program is urging the agency to ditch the 35-year-old program and start fresh.
After 16 months of work, the IOM committee, chaired by David Challoner, VP for health affairs emeritus at University of Florida, released its long-awaited, and sure-to-be controversial, recommendations July 29 in a 245-report titled "Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years."
With clear regulatory approval paths in Europe and growing markets in Asia and other developing markets, device executives and investors see international markets as increasingly attractive alternatives for clinical validation, revenue, and regulatory approval.
The 510(k) program and plans by FDA to reform it have caught the attention and anxieties of the device industry. And Christy Foreman's frequent flyer miles have swelled as a result. The acting director of the Office of Device Evaluation within the agency's Center for Devices and Radiological Health (CDRH) has traveled from coast to coast answering questions and attempting to allay concerns about FDA's plans for the 510(k) program, which is used by companies to bring more than 90% of new devices to the US market. In late October, Foreman participated in a panel at Elsevier Business Intelligence's IN3 Summit in San Francisco. There, she joined two other prominent individuals in the industry for a discussion of the 510(k) program and possible impending changes to it.
Republicans in Congress introduced bills last week that would repeal the medical device excise tax before it takes effect in 2013, but few Democrats have jumped on board publicly so far.
Device manufacturers are lining up against a number of FDA's proposed reforms to its 510(k) pre-market notification process, saying they could harm, not help, the agency’s public health mission.
Patient and consumer advocates are suggesting FDA request considerably more funding from device companies in the next round of user fee negotiations, but companies are reluctant to foot more of the bill for device reviews without seeing promised improvements in FDA's pre-market program.
Standard balloon-tipped angioplasty catheters can enter the market through the 510(k) clearance process, rather than the PMA route, beginning next month.
CDRH has sent warning letters to two different orthopedic firms in the past month charging that the companies' personalized knee surgery instrumentation systems are being marketed without proper clearance or approval.
China has become especially enticing as an unpenetrated, gigantic health care market, especially since the government in 2009 signed into effect a health care reform bill promising $125 billion over a three-year period to modernize the infrastructure of health care and provide insurance coverage to hundreds of millions of people. Medical device companies look to China as an enormous and rapidly growing market for medical disposables and equipment. However, the complex nature of the distribution infrastructure in China will make it difficult for companies to get a foothold. Headquartered in Beijing, TCT Medical Inc., which recently received $10 million in venture funding from Fidelity Asia Ventures and Fidelity Biosciences, its sister firm in the US, offers a potential solution for companies focused on women's health, and a model for the future.
