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A pair of resolutions proposed by Anvisa would give manufacturers of in vitro diagnostics and low-risk medical devices an easier time registering their products in Brazil. Read More
Lack of FDA clarity on when 510(k)s need to be filed for modified devices led Smith & Nephew to temporarily pull a wound care product from the market. Read More
The FDA’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
Lawyers are advising devicemakers preparing conflict mineral reports due to the Securities and Exchange Commission this month to put more effort into describing their compliance with the Organisation for Economic Co-operation and Development’s due diligence guidelines. Read More
CINCINNATI — With September’s deadline for displaying unique device identifiers on high-risk devices just around the corner, rollout for many manufacturers is well underway. Read More
U. S. industry group AdvaMed has hung up its shingle in Shanghai, aiming to play a more proactive role in regulatory and reimbursement policies impacting devicemakers in China. Read More
The Asian Harmonization Working Party has issued a white paper describing a system of qualifications and classifications for the use of software as a medical device. Read More
Evaluations of diagnostic test accuracy studies should include separate meta-analysis of positive and negative likelihood ratios, according to a draft guideline by the EU Network for Health Technology Assessment. Read More
The U.S. Food and Drug Administration’s guidance development process is in need of a major revamp to speed efforts along and integrate feedback from stakeholders earlier, devicemakers and officials in the Center for Devices and Radiological Health said during a June 5 public workshop. Read More
Australia’s Therapeutic Goods Administration logged a total of 3,309 adverse event reports in 2013, the overwhelming majority from manufacturers, according to a new report. Read More
Australia’s medtech industry association released a white paper last month calling for the Therapeutic Goods Administration to shift its focus from conducting conformity assessment reviews to designating authority of third-party conformity assessment bodies. Read More
Results from Team-NB’s third member survey shows a 10 percent decline in the number of ISO 13485 certificates issued to devicemakers last year. Read More