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The Brazilian government is providing more clarity around a voluntary program that encourages public-private partnerships to expand access to affordable medical devices and diagnostics, but questions remain about the program’s transparency. Read More
EU leaders are deadlocked over a proposed premarket mechanism for the highest-risk devices, and the stalemate threatens to delay adoption of a major overhaul in device and diagnostic regulations until late next year or even 2016. Read More
Devicemakers whose products include a drug component could find GMP compliance especially tricky, due to a 2013 regulation that requires expiration dates like those used for drugs, an industry expert says. Read More
India’s Central Drug Standards Control Organization has issued a draft guideline on good manufacturing practices for medical devices and diagnostics — the latest in an effort to increase the quality of medtech products, which are governed loosely under the country’s drug laws. Read More
An FDA decision to allow multiple entities to issue unique device identifiers could backfire and actually impede the uptake of UDI, medical device and healthcare industry experts warn. Read More
The FDA has warned Miami-based Trucare Biomedix-USA over slips on supplier audits, purchasing controls and other good manufacturing practices. Read More
Inadequate CAPA procedures led all other causes for Form 483s issued to devicemakers in fiscal 2014, while purchasing control issues jumped from sixth place to third in the FDA’s annual ranking of inspection observations. Read More