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The FDA slapped Sollentuna, Sweden-based MKL Diagnostics with a warning letter for failing to have a design control procedure for its Phadebact test kits. Read More
Cook Medical is under pressure from the FDA to fix sweeping quality problems at its Indiana facility relating to how the devicemaker addressed more than 735,000 manufacturing nonconformances over a two-year period. Read More
Using QSIT for internal audits could put devicemakers in a much stronger position when FDA investigators coming knocking on the door, compliance experts agree. Read More
Devicemakers have a better shot at emerging from an FDA inspection unscathed if they watch for common investigator tactics, such as stepping away from the company contact, an expert says. Read More
Medtronic cleared the final regulatory hurdles ahead of its planned $43 billion merger with Covidien, getting a positive nod from antitrust bodies in China and South Korea. Read More
Medical software that allows caregivers to noninvasively evaluate blood flow in patients with coronary artery disease gained marketing clearance from the FDA late last month. Read More
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
Greiner Bio One Brasil Produtos ran afoul of the FDA after documenting design changes in informal meetings with informal notes, a recent warning letter shows. Read More
A government report shows increasing consolidation in the diabetes test strip market since stricter parameters on Medicare coverage of mail-order testing supplies took effect. Read More
Medical devices labeled as latex-free or lacking latex need updated labeling with the more scientifically accurate statement “not made with natural rubber latex,” according to FDA final guidance. Read More
Navilyst Medical, a subsidiary of AngioDynamics, received an FDA warning letter for quality issues at two facilities, including the sale of sterile product that contained foreign matter such as hair. Read More
Indian regulators are establishing quality manufacturing standards for medical devices and diagnostics to align the country’s requirements with international standards and move away from its system of regulating the products under rules designed for drugmakers. Read More