Medical Devices Today

510(k) Face-Off: CDRH's Foreman Debates Reform Plans With Industry Reps

Article preview from IN VIVO - January 1, 2011

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 Renew Push To Repeal Device Tax; Broad Support Questionable

Article preview from "The Gray Sheet" - January 31, 2011

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.

Industry Takes Aim At Several Proposals In FDA’s 510(k) Report – Comments

Article preview from "The Gray Sheet" - October 6, 2010

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.

FDA User Fee Renewal Effort Should Include Pre-Market Refinements, Industry Says

Article preview from "The Gray Sheet" - September 15, 2010

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.

Balloon Angioplasty Catheters Gain Quicker Path To Market Under FDA Rule

Article preview from "The Gray Sheet" - September 8, 2010

Standard balloon-tipped angioplasty catheters can enter the market through the 510(k) clearance process, rather than the PMA route, beginning next month.

FDA Targets Personalized Knee Surgery Systems With Warning Letters

Article preview from "The Gray Sheet" - August 25, 2010

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.

TCT Medical Offers A New Model For Device Distribution In China

Article preview from Start Up - July, 2010

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.

FDA Attempts To Carve Out Regulatory Policy For Cytogenetic Tests

Article preview from "The Gray Sheet" - July 12, 2010

FDA is taking a proactive look at a new type of complex genetic test that challenges the agency's typical model for reviewing and approving diagnostics.

Outpatient Payment Draft Supports Preventive Health Care Screening Tests

Article preview from "The Gray Sheet" - July 12, 2010

Medicare beneficiaries would no longer have to pay coinsurance for certain colorectal cancer screening tests under CMS' 2011 Outpatient Prospective Payment System proposed rule.

Massachusetts Cost-Control Model Aims For More Deliberate Device Use

Article preview from "The Gray Sheet" - July 12, 2010

A program launched two years ago at a major Massachusetts health insurer appears poised to slow the growth of several device-intensive procedures.