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The China Food and Drug Administration has published a list of roughly 130 Class II devices that are exempt from submitting clinical trial data. Read More
San Diego-based Illumina will begin filling orders for its high-throughput gene sequencing tests and two other diagnostics by the end of the year, following FDA 510(k) clearance of all four devices. Read More
Medical devicemakers should avoid recruiting and putting at risk an unnecessarily large number of patients in clinical trials, the UK’s Medicines and Healthcare products Regulatory Agency says in one of five trial-related guidances issued last month. Read More
The FDA has warned an online marketer of genetic tests to pull its products off the market until it obtains regulatory clearance, saying the company has not demonstrated that the tests do what it claims they do. Read More
An interim report on the joint assessments of EU device notified bodies (NBs) shows there is room for improvement in the planning, scope and depth of surveillance activities. Read More
Avacen, maker of The Avacen Thermal Exchange System (TATES), was hit with a nine-citation FDA warning letter for failing to establish a host of essential GMP procedures. Read More
Devicemakers whose reported payments under the Physician Payment Sunshine Act are frequently disputed could wind up in the crosshairs for a government audit. Read More
Makers of in vitro diagnostics meant for research or investigational use only should take care not to encourage commercial use of their products. Read More
A durable medical equipment provider pleaded guilty Nov. 21 to one count of healthcare fraud in the U.S. District Court for the Southern District of Florida in a scheme the Justice Department says defrauded Medicare of more than $11 million. Read More
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