Acme Monaco received an FDA warning letter for failures related to design validation, process validation and other GMP issues. Read More

Routine quality system surveillance inspections of foreign devicemakers increased by 93 percent in 2012, according to newly released FDA data. Read More

CINCINNATI — CDRH’s Office of Compliance expects to begin work on a public database of device quality information, such as MDR reports, by the end of the year, OC Director Steven Silverman told devicemakers Wednesday at the FDA/Xavier University MedCon conference. Read More

There has been a steady uptick in the number of FDA 483s that cite inadequate supplier controls — from 84 in 2011, to 110 in 2012 and 126 last year. Read More

American Medical Systems was handed an FDA warning letter for failure to conduct an investigation and other quality slips. Read More

The European Commission’s Scientific Committee on Emerging Newly Identified Health Risks is recommending a step-by-step approach to the introduction of new or technically modified metal-on-metal joint implants, citing continued concerns about the higher risks and poorer durability vis-à-vis alternative materials such as polyethylene. Read More

The China Food and Drug Administration last month unveiled long-awaited reforms to its medical device regulations, breathing longer life into product licenses, but imposing first-time fees for device registrations. Read More