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Moon Marine USA Corporation voluntarily recalls frozen raw yellowfin tuna product “Nakaochi Scrape†associated with a multistate outbreak of Salmonella Bareilly infections
Recall — FDA Press Release  Moon Marine USA Corporation voluntarily recalls frozen raw yellowfin tuna product “Nakaochi Scrape” associated with a multistate outbreak of Salmonella Bareilly infections  Contact:Consumer:888-INFO-FDA Media:Curtis [email protected] FOR IMMEDIATE RELEASE – April 13, 2012 Fast Facts Moon Marine USA Corporation (also known as MMI) of Cupertino, Calif. is voluntarily recalling 58,828…
Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (P980023/S046, P910023/S270, P030054/S196).
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PMA Final Decisions for February 2012
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Evaluation of Automatic Class III Designation (De Novo) Summaries: K100534 added
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FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone
This update is in follow-up to the FDA Drug Safety Communication posted on 9/26/11: Â Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone. Safety Announcement [4-10-2012] The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood…
Innovation Pathway 2.0
Innovation Pathway at FDA HHS Secretary Sebelius on FDA’s Innovation Pathway Patients deserve faster access to safe and effective medical devices that address unmet public health needs. The FDA’s Innovation Pathway is a new way of doing business within our existing regulatory framework that could yield significant benefits to patients in the U.S. by giving…
CDRH Learn (New Module – Factors to Consider When Making Benefit
Listed below are the courses CDRH currently offers. Additional online courses are being developed and will be posted upon completion. Course List Overview of Regulatory Requirements: Medical Devices [Updated! 11/29/2011] Guidance Documents and Standard Operating Procedures (SOPs) [Updated! 04/10/2012] Premarket Notification Process – 510(k) Investigational Device Exemption Process – IDE [Updated! 2/23/2012] Bioresearch Monitoring (BIMO)…
Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots
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Guidance for Industry and Food and Drug Administration Staff
Document issued on: April 6, 2012 The draft of this document was issued on April 29, 2010. OMB Control No. 0910-0705 Expiration Date: 3/31/2015 See additional PRA statement in Section VIII of this guidance For questions for the Center for Devices and Radiological Health regarding this document contact the Premarket Notification (510(k)) Section at 301-796-5640….