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The FDA has published a unique device identification compliance guide aimed at helping small manufacturers prepare for UDI implementation, the first stage of which comes due next month. Read More
Manufacturers may soon be able to check how their devices are progressing through the 510(k) review process, under an experimental program being developed by the FDA. 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
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
Canadian devicemakers are praising their government’s plan to implement an internationally harmonized system of unique device identification, but say it must become “truly global” to avoid additional barriers to trade. Read More
The FDA roundly rejected a citizen’s petition from the Minnesota Medical Device Alliance that had sought multiple changes to the 510(k) notification process. Read More
Manufacturers of moderate-risk devices with a good record of GMP compliance could see less of government inspectors, under proposed amendments to South Korea’s good manufacturing practice regulations. Read More
Democratic lawmakers pressed President Barack Obama last week to use his executive authority to bar U.S. corporations from dodging taxes by acquiring a smaller foreign business and moving their headquarters overseas. Read More
With five new medical device regulations set to take effect in China on Oct. 1, industry insiders are worried the short transition period will affect supply of products in the country. Read More
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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