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The U.S. Food and Drug Administration’s new changes to data elements within its Global Unique Device Identification Database have dealt a setback to manufacturers who were well into the process of assigning UDIs to their products. Read More
As of April, EU member states and the European Commission had conducted five mandatory joint assessments of notified bodies, with one resulting in a negative decision, according to a working document prepared by Commission staff and presented to the Council of the European Union. Read More
For the first time, manufacturers submitting 510(k)s would have to show FDA reviewers that the risks and benefits of a candidate device are acceptable and substantially equivalent to those of the predicate device, according to draft guidance issued last week. Read More
The China Food and Drug Administration published 120 new medtech standards covering everything from metal spine implant system components to blood analyzer reagents, total knee and hip implants and endoscopic instruments. Read More
New requirements for the clinical evaluation of medical devices in China, part of a regulatory overhaul that took effect June 1, could slow the introduction of innovative technologies there, an industry observer says. Read More
Sponsors designing clinical trials that involve certain vulnerable patient populations will soon face greater scrutiny from institutional review boards, under newly issued FDA guidance. Read More
The FDA has rejected a call for a total ban on transvaginal mesh products, saying complete market withdrawal is not an appropriate way to deal with serious safety concerns linked to the devices. Read More
Before manufacturers complete their risk-management processes, they should perform a risk-benefit analysis for any risks that are unacceptable under Annexes Z in EN ISO 14971: 2012, and for which further risk reduction is possible, according to a draft consensus paper from the EU-based Notified Body Recommendation Group. Read More
While the recent self-recusal of FDA advisory committee member Andrew Brill has drawn attention to conflict-of-interest issues, the agency says it is having better luck filling the gaps on its advisory panels than in years past. Read More
Proposed changes to the way the FDA considers risks and benefits of 510(k) devices could undermine the efficiency and predictability of the popular market clearance route, a lead industry attorney says. Read More
Manufacturers of all in vitro diagnostics now have until June 30, 2015, to file an application for inclusion of currently marketed products on the Australia Register of Therapeutic Goods. Read More
The device industry is asking the FDA not to impose controls, including quality system regulations, on manufacturers of low-risk health information management software that doesn’t serve a clinical function. Read More