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Manufacturers of home-use devices should conduct usability tests early in design development and at later stages as the product evolves to ensure that user interaction problems caused by human factors have been addressed, the FDA says in final guidance released Tuesday. 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.
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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
The UK’s Medicines and Healthcare products Regulatory Agency is strengthening its ability to respond to postmarket medical device safety issues by creating a fast-acting committee of expert advisors that can rapidly review safety problems. Read More
Med-Mizer, a maker of electric, adjustable and bariatric hospital beds, received an FDA warning letter for failing to submit a timely MDR following a patient death. Read More
The FDA has warned Smith & Nephew for failing to report a recall of the Renasys soft port dressing, used with the company’s Renasys line of negative pressure wound treatment devices.
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The Department of Commerce plans to submit a list of all known conflict mineral processing facilities to Congress by Sept. 1, according to a recent report from the Government Accountability Office. GAO recommends that DOC give Congress a plan, including timeframes, for compiling and reporting the information, which was supposed to be completed by January 2013. Read More
Over the next four years, the FDA plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More
Devicemakers could spare themselves time and money by checking with UDI-issuing agencies to see if they have a current account before applying for new licenses, a former FDA official says. Read More
More than 100 members of Congress are calling on the HHS Office of Inspector General to assess the effects and consequences of the competitive bidding program for durable medical equipment, prosthetics, orthotics and supplies in advance of plans to further expand the program. Read More