FDA Extends UDI Deadlines Another Two Years for Class I, Unclassified Devices
The FDA said it will allow device manufacturers of Class I and unclassified devices another two years to comply with its unique… Read More
China Implements New Review Mechanism for Innovative Devices
China’s State Drug Administration is implementing a new device review procedure to bring innovative devices to market faster and to encourage more innovation in China’s supply chain. Read More
Devices News
FDA Approves Reconfigured OTC Asthma Inhaler
FDA Commissioner Scott Gottlieb offered assurances about the agency’s approval of an OTC asthma inhaler that was previously pulled from the U.S. market in 2011. Read More
Warning Letter Roundup: Three Firms Cited for Adulterated Devices
The FDA hit three foreign device manufacturers with warning letters, calling the firms out for quality system violations that led to adulterated products. Read More
EC Adds Four Devices to Manual on Borderline and Classification
The European Commission added four new products it considers devices to its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices, including several related to contraception. Read More
483 Roundup: FDA Cites Firms for Quality, Risk Analysis and SOPs
Three devicemakers drew 483s for quality system and other failures observed during FDA inspections. Read More
