Aparatos médicos

Destacados

• FDA announces public-private partnership to develop regulatory science that will speed patient access to new medical device technologies
• Improvements in Device Review: Results of CDRH's Plan of Action for Premarket Review of Devices
• National Medical Device Postmarket Surveillance Plan
• CDRH Mission, Vision and Shared Values
• CDRH 2013 Strategic Priorities

Recalls & Alerts

• FDA warns against improper advertising, promotion of lasers intended for LASIK corrective eye surgery
• Narrowed Indications for Use for the Stryker Wingspan Stent System
• List of Recalls
• Safety Communications
• Medical Device Reporting (MDR)

Approvals & Clearances

• FDA permits marketing of first test that can simultaneously identify 11 causes of infectious gastroenteritis
• FDA permits marketing of device to seal lung punctures
• Recently-Approved Devices
• 510(k) Clearances
• PMA Approvals

Tools & Resources

• Device Registration and Listing
• Medical Device Databases
• FDA Recognized Consensus Standards Database
• CDRH Ombudsman
• Requesting Speakers from CDRH

Comuníquese con la FDA