The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Nearly four years after the Food & Drug Administration warned Boston Scientific Corp. (NYSE: BSX) that it was on thin ice, the medical device maker says the federal watchdog agency granted absolution on all issues raised in a 2006 warning letter.
In January of that year, the FDA sent then-CEO James Tobin and chairman Peter Nicholas a stern missive warning that multiple inspections of six plants around the country revealed "serious regulatory problems involving your medical devices."
Citing unprecedented future demands on the Food & Drug Administration, a group of five Democrats in the House and Senate sent an open letter to U.S. Dept. of Health and Human Services secretary Kathleen Sebelius, urging her to boost the Food & Drug Administration’s budget for 2012.
“After years of inadequate budgets, FDA finally received real increases in fiscal years 2008, 2009, and 2010, which enabled FDA to restore the staffing losses incurred since the early 1990s,” the legislators wrote. “However, the FY 2011 budget for FDA barely kept up with inflation, and the agency is faced with far more problems and challenges than it had in 1994.”
The Centers for Devices and Radiological Health released a list of “best practices” for medical device companies performing animal studies as a precursor to human trials.
The purpose of the report, which has been in the works for some time, is to “provide a reference of best practices for the approach, conduct, and presentation of animal study data intended to demonstrate that the device under study is sufficiently safe for early human experience, while accounting for modern animal care and use strategies,” according to the document.
Dr. William Maisel, a cardiologist at Boston’s Beth Israel Deaconess Medical Center, will chair the Center for Devices and Radiological Health’s new Center Science Council according to CDRH director Dr. Jeff Shuren.
The new Council will guide the agency in science based decision making.
The announcement was made earlier today in a conference call scheduled to discuss proposed changes to the Food & Drug Administrations’ 510(k) approval process.
More than 70,000 children are sent to the emergency room each year for injuries and malfunctions from medical devices, according to a study by researchers at the Food & Drug Administration.
Contact lenses account for about a quarter of the problems, with issues such as infection and eye abrasion that can result from wearing the lenses too long.
The Food & Drug Administration’s Center for Devices and Radiological Health established a website to aid the the industry in understanding the Center’s Kafka-esque approval process.
The site, called CDRH Learn, consists of training modules designed to educate the public on pre-market and post-market medical device and radiological health regulation. The resource includes video presentations and an exam to assess each user’s knowledge of approval processes.
Dr. Jeffrey Shuren, head of the Food & Drug Administration’s medical device oversight arm, told a Massachusetts audience that results from the agency’s internal, soup-to-nuts review of its 510(k) clearance program are due out in a few weeks.
At the second in a series of "town hall" meetings in Woburn, Mass., the Center for Devices & Radiological Health’s leader said the federal watchdog would seek public comment on the report before making any changes to the program.
Shuren told MassDevice that the agency still hasn’t decided exactly what changes are in store for the 510(k) process.
The Food & Drug Administration plans to launch a public database of recall data this fall, another element in the agency’s quest to become more transparent.
The data, on recalls of medical devices, food products and drugs, will be compiled in a searchable, online database. The data will also be made available in a downloadable XML format.
The Food & Drug Administration wants the public’s help in figuring out whether its premarket approval process for medical devices is strict enough.
A pair of Minnesota legislators are lobbying against changes the Food & Drug Administration proposes for its 510(k) clearance protocol the industry says will hurt innovation and the state’s economy.
U.S. Sen. Amy Klobuchar (D:Minn.) and Rep. Erik Paulsen (R:Minn.) sent a letter to FDA Commissioner Dr. Margaret Hamburg, warning that overzealous regulation would hurt start-ups struggling to raise venture capital in a weak economy.
As part of its ongoing attempt to remove bureaucratic impediments from the development of medical devices, the Food & Drug Administration is planning a public workshop to address innovation in the medical device industry June 24 in Washington.
