Regulatory
PMA Final Decisions for June 2010
August 3, 2010 10:39 am | by U.S. Food & Drug Administration | News | CommentsThese are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for June 2010.
Accuray's CyberKnife G4 System Receives Shonin Approval
August 3, 2010 6:35 am | by Bio-Medicine.Org | News | CommentsSUNNYVALE, Calif. , Aug. 3 /- Accuray Incorporated (Nasdaq: ARAY ), a global leader in the field of radiosurgery, announced today it received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market the CyberKnife® G4 Robotic Radiosurgery System to...
FDA Summary of Safety and Effectiveness Data (SSED) Clinical Section Checklist
August 3, 2010 5:31 am | by U.S. Food & Drug Administration | News | CommentsThe Summary of Safety and Effectiveness (SSED) is a document mandated by the Food, Drug and Cosmetic Act subparagraph 520(h)(1)(A) to be publicly available upon issuance of an approval order of a premarket approval application (PMA).
Federal Register: Medical Device User Fee Rates for Fiscal Year 2011
August 3, 2010 5:31 am | by U.S. Food & Drug Administration | News | CommentsThe FDA is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2011. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee Amendments of 2007 (title II of the Food and..
Nimodipine Oral Capsules: Medication Errors - IV Administration May Result in Death, Serious Harms
August 2, 2010 1:30 pm | by U.S. Food & Drug Administration | News | CommentsIV injection can result in cardiac arrest, severe falls in blood pressure, and other heart-related complications.
NeoProfen (ibuprofen lysine) Injection: Recall and Shortage - Risk of Particulate Matter
August 2, 2010 10:30 am | by U.S. Food & Drug Administration | News | CommentsPotential for particulate matter to result in serious adverse effects.
Consumer Information on: OraQuick HCV Rapid Antibody Test - P080027
July 30, 2010 5:32 pm | by U.S. Food & Drug Administration | News | CommentsThe OraQuick HCV Rapid Antibody Test is used to detect a patient?s exposure to the hepatitis C virus (HCV). Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. The presence of the antibodies...
Summary Information for: OraQuick HCV Rapid Antibody Test
July 30, 2010 5:32 pm | by U.S. Food & Drug Administration | News | CommentsLabeling, Approval Order, and Summary of Safety and Effectiveness for OraQuick HCV Rapid Antibody Test (P080027).
NICE Recommends First Device Under New Technology Pathway
July 30, 2010 5:31 pm | by U.S. Food & Drug Administration | News | CommentsThe UK's National Institute for Health and Clinical Excellence (NICE) has given a provisional nod to B. Braun Medical's SeQuent Please balloon catheter for use in patients with in-stent restenosis in bare metal coronary artery stents, following the recommendation of the...
FDA Extends Comment Period on Reclassification Rule
July 30, 2010 5:31 pm | by U.S. Food & Drug Administration | News | CommentsThe FDA is giving devicemakers more time to comment on a proposed rule that would reclassify some devices as Class II and amend the regulations to establish special controls for others.
Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach
July 30, 2010 5:31 pm | by U.S. Food & Drug Administration | News | CommentsProduct sold online as a dietary supplement. When consumed as instructed, produces an industrial bleach that can cause serious harm to health.
Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change - Risk of Fever and Febrile Seizure
July 30, 2010 5:30 pm | by U.S. Food & Drug Administration | News | CommentsIncreased incidence of fever and febrile seizure among young children reported in Australia, mainly among those less than 5 years of age.
Nutraloid Labs ejaculoid XXTREME and stimuloid II: Undeclared Drug Ingredient
July 30, 2010 12:31 pm | by U.S. Food & Drug Administration | News | CommentsThese products, marketed as dietary supplements, contain sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerously low levels.
Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen
July 29, 2010 12:31 pm | by U.S. Food & Drug Administration | News | CommentsReports of adverse effects in children who may have been unintentionally exposed to the drug through skin contact with women using this product.
Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia
July 29, 2010 8:30 am | by U.S. Food & Drug Administration | News | CommentsCases of serious, potentially fatal pneumonia associated with the IV antibacterial drug Cubicin.
Federal Register: Neurological and Physical Medicine Devices; Designation of Special Controls for Certain Class II Devices and Exemption From Premarket Notification; Reopening...
July 28, 2010 6:34 am | by U.S. Food & Drug Administration | News | CommentsThe FDA is reopening until 9/7/2010, the comment period for the proposed rule published in the Federal Register of April 5, 2010 (75 FR 17093). The document proposed to amend certain neurological and physical medicine device regulations to establish...
Federal Register: Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
July 28, 2010 6:33 am | by U.S. Food & Drug Administration | News | CommentsOn 9/24/2010, the committee will discuss, make recommendations, and vote on a premarket approval application for the Selenia C Digital Breast Tomosynthesis System, sponsored by Hologic, Inc. The Selenia C Digital Breast Tomosynthesis System is intended...
Joint Statement on Wireless Medical Devices - U.S. Food and Drug Administration, Federal Communications Commission
July 27, 2010 7:30 am | by U.S. Food & Drug Administration | News | CommentsInnovation in broadband and wireless-enabled medical devices holds significant promise for enhancing health and reducing the costs of health care for all Americans. Examples include wireless sensors that remotely monitor heart rhythm and portable...
Medical Device Safety Tip: Air or Electric Dermatome Instruments
July 26, 2010 7:31 am | by U.S. Food & Drug Administration | News | CommentsFDA has received several reports of patients suffering lacerations when undergoing skin grafting procedures with air- or electric-powered Dermatome surgical instruments made by Zimmer, Inc. In one report, the device cut through to the bone and the...
FDA Cites Manufacturing Issues in Warning Letter to Abbott
July 23, 2010 4:31 pm | by U.S. Food & Drug Administration | News | CommentsAbbott Diabetes Care received a warning letter about manufacturing violations at its Alameda, Calif., facility, which makes FreeStyle and Navigator blood glucose monitoring products.
Devicemakers See Mixed Results in Second Quarter Earnings
July 23, 2010 4:31 pm | by U.S. Food & Drug Administration | News | CommentsBoston Scientific saw sales for its implantable cardioverter defibrillators (ICD) bounce back after a monthlong shipment hold and vows from physicians to switch to other devices.
Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays
July 23, 2010 10:30 am | by U.S. Food & Drug Administration | News | CommentsRecall due to balloon inflation assembly that may not hold air
Joyful Slim Herb Supplement : Recall-Undeclared Drug Ingredient
July 22, 2010 11:30 am | by U.S. Food & Drug Administration | News | CommentsProduct contains sibutramine; may increase blood pressure/pulse rate with risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, stroke.
CONSTELLATION Vision System: Recall
July 20, 2010 1:30 pm | by U.S. Food & Drug Administration | News | CommentsSoftware and hardware problems associated with unexpected system loss of power, unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems.
Vialipro Dietary Supplement: Recall-Undeclared Drug Ingredient
July 20, 2010 6:30 am | by U.S. Food & Drug Administration | News | CommentsLab analyses found that certain batches of Vialipro contain Sulfoaildenafil, an analogue of Sildenafil.
