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November 2019

No. 478

Headlines

Full Issue of The GMP Letter in PDF Format

Download and view the full issue. Read More

FDA Investigates Implantable Devices That Contain Metals

The FDA called for feedback on a newly released report on biological responses to metal implants and said it’s investigating possible adverse events linked to the devices. Read More

FDA Calls for Boxed Warning on Breast Implants

The FDA released new labeling recommendations and called for a boxed warning for breast implants in a new draft guidance. Read More

FDA Issues Labeling Advice for Intravascular Devices

In a newly released guidance, the FDA spells out what manufacturers need to consider when labeling catheters, wires and delivery systems with lubricious coatings used during minimally invasive diagnostic and therapeutic vascular procedures. Read More

FDA Warns Wheelchair Manufacturer for Misbranding

The FDA issued a warning letter to 21st Century Scientific for misbranding of its powered wheelchairs. Read More

HHS Inspector General to Analyze Postmarket Surveillance

HHS’ Office of Inspector General (OIG) announced plans to release a report on the medical device postmarket surveillance system next year. Read More

483 Roundup: Six Firms Cited for Quality, Other Compliance Failures

The FDA hit six devicemakers for a range of compliance failures observed during facility inspections, including lax acceptance procedures and missing records. Read More

CDRH Releases Guidance Priorities for Fiscal 2020

CDRH released a list of priority guidances it plans to publish during fiscal 2020, including numerous quality-related final and draft guidances. Read More

FDA Plans to Exempt Five Class II Devices From Premarket Notification

The FDA is proposing to exempt additional Class II medical devices from 510(k) premarket notification requirements. Read More