Healthcare titan Abbott (NYSE:ABT) today announced Japanese regulatory approval for its next-generation portfolio of Xience Xpedition drug-eluting stents.
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
FDA aims to clear confusion, prevent errors in medtech adverse event reports
The FDA this week issued a new draft guidance on how the agency regulators adverse event reporting for medical devices, seeking to revise rules last updated in March 1997.
The new guidance document is lengthy and extensive, covering frequently asked questions as well as common reporting errors committed by medical device makers, according to the FDA.
FDA wants to downgrade blood access devices
The FDA recommended bumping blood access devices down from Class III to Class II regulatory status, based on mounting evidence that these implanted tubes, catheters and cannulae belong in a lower-risk category.
The federal watchdog agency said there’s enough safety and efficacy data to peel off a layer of regulatory oversight. Unlike the highest-risk Class III category, Class II devices are subject special controls, such as labeling rules and performance standards, but are exempt from the FDA’s stringent pre-market approval protocol and its attendant clinical trial requirements.
FDA plows forward with researcher misconduct privacy rule
The FDA this month issued a rule that would keep confidential certain records pertaining to investigations into potential researcher misconduct at the National Institutes of Health, exempting such documents from federal Privacy Act requirements.
The rule aims to protect the identities of confidential sources in NIH investigations by preventing researchers under investigation from accessing records pertaining to their proceedings, according to an FDA notice in the Federal Register.
Volcano extends deadline for $3M milestone payment for Crux Biomedical
Working together for new solutions to cancer in children
One of the greatest pleasures I have as FDA commissioner is the opportunity to meet with so many who are making a real difference in the world of health care, including researchers, doctors, drug industry leaders, foundations, and advocates for patients and families, including most recently the Alexandria Summit for Oncology.
E.U. scrutinizes medtech review “shopping” | MassDevice.com On Call
MASSDEVICE ON CALL — Under fire for being too lenient with medical device approvals, European regulators proposed an update to current CE Mark review and approval practices.
Specifically, the European Commission’s proposed changes address the relative ease with which companies can secure CE Mark approval by "shopping" for an agency in a specific country that will most quickly green-light a new device.
New rules for supplementary information requests in China
By Stewart Eisenhart, Emergo Group
Chinese medical device market regulators have enacted a new requirement regarding supplementary documentation requests (links to page in Chinese) related to registration with the China Food and Drug Administration (CFDA).
Effective June 1 2013, medical device registration applicants that receive CFDA requests for supplementary information must comply with the following rules:
Integra LifeSciences recall affects Medtronic’s Infuse kits
It’s a mad mad mad mad medtech world
Reuters recently reported that a growing number of U.S. cardiologists are expressing frustration with the lack of availability of newer cardiac devices in the United States as compared to Europe. Their beef: U.S. patients have to wait longer for access to beneficial next generation therapies.