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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FDA Releases Draft Guidance on Device Establishment Inspections

The FDA issued a new draft guidance laying out how the agency is updating uniform inspections—other than for-cause inspections—to reflect the FDA Reauthorization Act of 2017.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