Bloomington, Minn. — The federal official who oversees the review and approval of medical devices came to the Twin Cities May 18, to hear what industry leaders and medical experts have to say about how the agency is doing its job. They aired a host of complaints.
The Food & Drug Administration is proposing to expand the amount of information it reveals about its approvals process for medical devices and drugs, including revealing applications for investigational device exemptions and when it denies applications.
The 21 proposed changes, released May 19, are already drawing fire from industry. AdvaMed, the national lobby for the medical devices industry, said the proposed changes would weaken intellectual property protections and stifle innovation.
Dr. Jeffrey Shuren, director of the Food & Drug Administration’s medical device oversight arm, will present the Center for Devices and Radiological Health’s priorities for the upcoming fiscal year, which include facilitating innovation and increasing transparency.
The FDA branch launched a transparency website in April to share information about its decisions on medical devices and radiation-emitting products. The CDRH is also hoping to address how the FDA engages with the medical device industry.
U.S. regulators are requiring Baxter Healthcare Corp. (NYSE:BAX) to pull all of its Colleague infusion pumps from the market, accusing the medical device manufacturer of a “long-standing” failure to correct problems with the pumps.
As part of its enforcement action, the Food & Drug Administration ordered the Deerfield, Ill.-based company to provide refunds to customers or to replace the pumps at no cost. Both the agency and the company estimate there are about 200,000 of the pumps currently in use.
The Food & Drug Administration is proposing to raise the user fees it charges medical device makers seeking to have their devices approved for market.
The FDA’s 513(g) request for classification process allows device makers to ask the federal watchdog agency how their devices should be classified and what protocol they should use to seek clearance or approval. The agency sets two tiers, one for businesses with more than $100 million in sales and another, lower fee rate for smaller businesses.
The Food & Drug Administration is warning that about 280,000 external defibrillators around the world could malfunction due to a faulty component made by Cardiac Science Corp. (NSDQ:CSCX).
The FDA said the problem could cause the devices, designed to shock the heart back to beating after sudden cardiac arrest, to fail to deliver a shock.
The Food & Drug Administration is making changes to the way its advisory panels deliberate over and vote on medical devices under review by the federal watchdog agency.
As of May 1, the FDA is instituting new procedures for the panels, groups of experts assembled to review and discuss data and information on devices undergoing pre-market review.
The Food & Drug Administration made its first moves toward stricter regulation of infusion pumps, issuing proposed new guidelines advising manufacturers of the devices that they’ll likely have to run more in-depth clinical trials before the FDA clears new pumps.
In March, the federal watchdog agency convened a panel to review the risks posed by the pumps, after 18 recalls were issued for the devices over a five-year period.
The Food & Drug Administration launched a new initiative aimed at improving the safety of complex medical devices used by patients and caregivers in the home.
The federal watchdogs want to reduce the number of adverse events involving hemodialysis equipment, wound care, intravenous therapy devices and ventilators that patients and their caregivers are increasingly using at home, often without the supervision of doctors or other medical staff.
The Food & Drug Administration launched a transparency website for the Center for Devices and Radiological Health, part of its ongoing transparency initiative.
The new CDRH site will host new information on the agency’s decisions regarding medical devices and radiation-emitting products.
Other topics on the website include pre-market and post-market submissions on product performance and safety, science and research, educational resources and CDRH performance data.
Cambridge Heart Inc. (OTC:CAMH) won a much-needed nod from the Food & Drug Administration when the watchdog agency cleared an OEM version of its microvolt T-wave alternans cardiac monitor.
The 510(k) clearance means the Tewksbury, Mass.-based firm can move forward with a deal it struck last year with Cardiac Science Corp. (NSDQ:CSCX) to incorporate the MTWA device into Cardiac Science’s Q-Stress line of heart stress-testing equipment.