Archive for January 2020
FDA Issues Guidance on PTA Balloon, Specialty Catheter 510(k) Submissions
The FDA released draft guidance for devicemakers on 510(k) submissions for catheter-based devices intended to treat peripheral vasculature lesions, including suggestions on labeling and performance testing. Source: The GMP Letter
Read MoreChinese Devicemaker Warned for Testing Deficiencies
The FDA slapped Henan Kangdi Medical Devices with a warning letter over repeat CGMP failures at its Zhoukou, Henan facility, including a lack of testing. Source: The GMP Letter
Read MoreEU Rolls Out New Guidance on Cybersecurity
The EU’s Medical Device Coordination Group released new guidance on cybersecurity requirements for devicemakers under the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). Source: The GMP Letter
Read MoreNew ISO Standard Helps Devicemakers Manage Risk
The International Organization for Standardization released a new standard to help devicemakers improve their risk management. Source: The GMP Letter
Read MoreCanada Releases Final Guidance on Software as a Medical Device
Health Canada has finalized guidance on software as a medical device (SaMD) that clarifies how it fits into the agency’s regulatory framework and how devicemakers can comply. Source: The GMP Letter
Read MoreFederal Judge Says FDA Can’t Regulate Barium Product as a Drug
A federal judge has ruled that the FDA can no longer regulate barium sulfate as a drug. Source: Drug GMP Report
Read MoreSwiss Regulator Writes Up Indian Firm for Multiple Violations
Switzerland’s drug agency Swissmedic rapped an Indian drugmaker for significant CGMP violations at a facility near Mumbai. Source: Drug GMP Report
Read More483 Roundup: Seven Firms Rapped for Complaint Handling, Other Issues
The FDA has issued Form 483 inspection reports to seven drug companies for a variety of GMP and other lapses, including problems with data integrity, complaint handling and visual examinations of finished drug products. Source: Drug GMP Report
Read MoreRegulators Target Diabetes Drug Metformin for NDMA Contamination
Healthcare regulators have set their sights on type 2 diabetes drug metformin to see if it contains unsafe amounts of N-nitrosodimethylamine (NDMA). Source: Drug GMP Report
Read MoreWarning Letter Roundup: U.S. Firms Hit for GMPs, Other Letdowns
Four U.S. drugmakers drew FDA warning letters for violations ranging from the use of contaminated water to the promotion of unapproved drug products. Source: Drug GMP Report
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