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. Source: The GMP Letter
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. Source: The GMP Letter
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. Source: The GMP Letter
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. Source: The GMP Letter
FDA Warns Wheelchair Manufacturer for Misbranding
The FDA issued a warning letter to 21st Century Scientific for misbranding of its powered wheelchairs. Source: The GMP Letter
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…
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The FDA released new labeling recommendations and called for a boxed warning for breast implants in a new draft guidance. Source: The GMP Letter
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. Source: The GMP…