CDRH Learn (Spanish): 510(k) Third Party Review Online Video Presentation and Printable Slide Presentation

Listed below are the courses CDRH currently offers in Spanish. Additional online courses are being developed and will be posted upon completion. Course List Quality System Regulation 21 CFR Part 820 Basic Introduction Export Certificates for Medical Devices Overview of the Premarket Notification Process – 510(k) [New! 5/18] Bioresearch Monitoring (BIMO) [New! 7/25] Medical Device [...]

FDA Alerts Health Care Professionals of Infection Risk from Repackaged Avastin Intravitreal Injections

<!– –> <!– Page Last Updated: 08/30/2011 –> Page Last Updated: 08/30/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/Drugs/DrugSafety/ucm270296.htm

Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring

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ShoulderFlex Massager by King International: Safety Communication

<!– –> <!– Page Last Updated: 08/26/2011 –> Page Last Updated: 08/26/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm269765.htm

H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall

  Multiple brands affected – listed below [Posted 08/26/2011] AUDIENCE: Pharmacy, Consumer, Risk Manager ISSUE: H P Industries and FDA notified health professionals and the public of a recall of all lots (lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C) of Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel. H P Industries, Inc. manufactured [...]

Life-Threatening Injuries Associated with the ShoulderFlex Massager

Date Issued:  August 25, 2011 Audience: Consumers who have purchased or use the ShoulderFlex Massager Businesses that sell the ShoulderFlex Massager Health care professionals who recommend the ShoulderFlex Massager to their patients Medical Specialties: Physical Therapy, Orthopedics, Physical Medicine Device:   The ShoulderFlex Massager, distributed by King International in Beaverton, OR, is a personal massage device [...]

NovoSevenRT

<!– –> <!– Page Last Updated: 08/24/2011 –> Page Last Updated: 08/24/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm089232.htm

FDA Drug Safety Communication: Abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide)

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary    Safety Announcement [8-24-2011] The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide; also marketed as generics) should no longer be used at doses greater than 40 mg per day because it can cause abnormal [...]

Celexa (citalopram hydrobromide): Drug Safety Communication

<!– –> <!– Page Last Updated: 08/24/2011 –> Page Last Updated: 08/24/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm269481.htm

Kogenate FS

<!– –> <!– Page Last Updated: 08/23/2011 –> Page Last Updated: 08/23/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm089055.htm