Australia Rolls Out Work Plan to Engage With International Regulators
Australia’s TGA released a new work plan spelling out how it will engage with overseas regulators to increase information sharing and regulatory convergence. Read More
FDA to Rely More on 510(k) Reviews Conducted by Third Parties
The FDA released a comprehensive new plan that proposes to rely more on reviews conducted by third parties to streamline its review process and avoid re-reviews of 510(k) applications. Read More
Devices News
FDA Warns ITG-Medev for Validations, Other Failures
ITG-Medev failed to follow up on its promised solutions to nonconforming process validations and documentation of acceptance activities, the FDA said in a warning letter to the devicemaker. Read More
Stakeholders Ask FDA to Clarify CGMP Guidance on Combination Products
AdvaMed and other industry groups asked the FDA to provide more details on the agency’s proposed list of alternative mechanisms for compliance with CGMP requirements for combination products. Read More
South Korea’s Mi Gwang Contact Lens Short-Sighted on Quality
Numerous quality system failures were uncovered at South Korea’s Mi Gwang Contact Lens Company during a March 2018 FDA inspection. Read More
Buffalo’s Graphic Controls Acquisition Fails to Control Product
Devicemaker Graphic Controls Acquisition lacked numerous procedures to ensure that products conformed to specifications, according to a 483 the firm received following a May 8 -14 inspection of its Buffalo, New York facility. Read More