Simplifying Global Compliance
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April 2019
No. 471
Headlines
Full Issue of The GMP Letter in PDF Format
Download and view the full issue. Read More
FDA Releases Draft Guidance on Device Establishment Inspections
The FDA issued a new draft guidance laying out how the agency is updating uniform inspections—other than for-cause inspections—to reflect the FDA Reauthorization Act of 2017. Read More
CDRH Begins Reorganization Towards Team-Based Approach
CDRH has launched a major shakeup that will create several new offices—including one “super office” for product evaluation and quality. Read More
FDA Proposes Total Product Lifecycle Approach to AI Devices
The FDA is considering a total product lifecycle monitoring approach to emerging artificial intelligence devices, the agency said in a proposed rulemaking issued April 2. Read More
FDA Warns Two Breast Implant Makers Over Post-Approval Studies
Two breast implant manufacturers were served with warning letters after the FDA found they failed to comply with post-approval study requirements. Read More
FDA Moves to Improve Mammography Quality Standards
The FDA issued a proposed rule aimed at modernizing mammography quality standards and better positioning the agency to act when violations are found. Read More
TGA Ends Three Year Transition to ISO 13485:2016
Australia’s Therapeutic Goods Administration reached the end of its three-year transition period to the 2016 version of ISO 13485 and devicemakers using the updated standard to show Quality Management System (QMS) conformity are now expected to have their systems up-to-date. Read More
483 Roundup: Six Device Firms Cited for GMP, Other Failures
The FDA hit six facilities for various failures including inadequate validations, CAPAs, written procedures and supplier evaluations. Read More
MITA Urges FDA to Clarify Servicing And Remanufacturing Differences
The Medical Imaging & Technology Alliance is calling on the FDA to establish a framework that distinguishes between servicing and remanufacturing activities for medical imaging devices. Read More
FDA Lays Out New Guidance on Anthrax Testing Devices
The FDA released new guidance for devicemakers hoping to sell equipment to test for anthrax and other dangerous bacteria. Read More
EC Issues Guidance on Eudamed, Nomenclature System
The European Commission released long-awaited guidance on Eudamed (the European Database on Medical Devices) and the device nomenclature system that will be used for the EU’s new medical device and in vitro diagnostic regulations. Read More
CDRH Warns of Device Shortages Following Sterilizer’s Suspension
CDRH warned that more than 100 device manufacturers and hundreds of devices face potential shortages following an EPA order to stop medical equipment sterilizer Sterigenics’ Willbrook, Illinois facility from sterilizing products with ethylene oxide. Read More
Australia Proposes New Device Classifications to Align With EU Regs
Australia’s TGA released five new draft guidances that propose changes to the classification of numerous medical devices to align more closely with European Union regulations. Read More
