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Speaking at the AdvaMed 2015 conference in San Diego, Calif., in October, an FDA representative and champion of the International Medical Device Regulators Forum Medical Device Single Audit Program renewed her call for participants in a pilot for the initiative, as companies have proven reluctant to join. Read More
For devicemakers concerned about complying with the 2013 final rule on combination products, one quality systems expert has this advice: Don’t panic. Read More
What are the barriers holding stakeholders back from having a shared view of risk? That question was at the heart of discussions held during a summit co-convened last week by the Association for the Advancement of Medical Instrumentation and the FDA. Read More
Russia’s device authority is taking a strong stance against counterfeit and unregistered products, according to representatives at separate events this month. Read More
Olympus America, Fujifilm Medical Systems and Pentax’s Hoya unit have 30 days to submit postmarket surveillance studies to the FDA detailing how their duodenoscopes are reprocessed in healthcare facilities. Read More
The International Medical Device Regulators Forum has unveiled a document it hopes will help industry understand how quality management can play a role in ensuring the quality and safety of devices that rely on software. Read More
Colombia’s Instituta Nacional de Vigilancia de Medicamentos y Alimentos has updated regulations governing the sanitary requirements related to laboratories developing external orthopedic prosthetics and orthotics. Read More
The China Food and Drug Administration has issued four guidelines that provide additional information for devicemakers awaiting good manufacturing practices inspections. Read More
The drumbeat for the removal of Bayer’s controversial implantable contraceptive device Essure is growing louder, with a federal lawmaker becoming the latest to urge the FDA to take it off the market until a well-designed study can demonstrate its safety and effectiveness. Read More
Roughly three months after the European Medicines Agency announced it was seeking additional information on the Inductos implant marketed by a Medtronic unit, the health body has recommended the suspension of the product. Read More
Failure to inform the FDA about a medical device correction or removal has earned Merge Healthcare, a developer of medical image handling and processing, interoperability and clinical systems, a warning letter. Word of the letter came just as IBM closed its deal to buy Merge, which will become part of IBM’s new Watson Health business for $1 billion. Read More
Theranos, a hot startup that recently received media scrutiny regarding its testing system, has been hit with two 483s, one of which takes the company to task for shipping an uncleared device. Read More