The Ceramax Ceramic Hip System is a ceramic on ceramic artificial hip replacement system, surgically implanted to completely replace a hip joint.
New labeling changes to emphasize the potential for severe liver failure and serious allergic reactions
Product marketed as a dietary supplement contains sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
The objective of this Town Hall meeting is to engage in a dialogue about issues that are of importance to the public.
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL): Medication Use Error - Reports of Accidental OverdoseJanuary 10, 2011 11:30 am | by U.S. Food & Drug Administration | News | Comments
Morphine sulfate oral solution ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product.
Federal Register: Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical Devices: Recommended Glossary and Educational Outreach To Suppo...January 7, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments
The guidance document provides guidance for the voluntary use of selected symbols in place of text in labeling. It provides the labeling guidance required for: (1) In vitro diagnostic devices (IVDs), intended for professional use under 21 CFR 809.10...
Underweight tablets may not contain the full amount of active ingredient within a single tablet. A consumer may not receive the prescribed dose, which may cause the infection the drug was intended to treat to worsen or recur, which could be life-threatening when treating severe infections.
Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination(2)January 6, 2011 11:31 am | by U.S. Food & Drug Administration | News | Comments
Use of contaminated Alcohol Prep Pads, Alcohol Swabs or Alcohol Swabsticks could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients.
AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platform - Class I RecallJanuary 5, 2011 9:30 am | by U.S. Food & Drug Administration | News | Comments
Use of affected devices may lead to retained device fragments or significant arterial injury which may lead to death or need for additional surgical intervention.
Federal Register: Draft Guidance for Industry and FDA; Establishing the Performance Characteristics of Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection and Dif...January 5, 2011 5:30 am | by U.S. Food & Drug Administration | News | Comments
The draft guidance document provides industry and Agency staff with updated recommendations for studies to establish the analytical and clinical performance of nucleic acid-based in vitro diagnostic devices (IVDs) intended for the detection and...
The FDA is amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial...
Products marketed as dietary supplements contain undeclared analogue of sildenafil, a drug which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
The primary purpose of the forecast is to help CDRH (and other medical device stakeholders) prepare for pioneering products that will pose new scientific questions and regulatory issues during the next decade. This preview it provides is intended to...
Acetadote (acetylcysteine) Injection: Recall - Particulate Matter Found in a Small Number of Vials(2)January 3, 2011 5:30 am | by U.S. Food & Drug Administration | News | Comments
6 lots of Acetadote is being recalled as a precautionary measure based on observed particulate matter found in a small number of vials.
Quality control issues involving Smith & Nephew’s ceramic acetabular hip implants have resulted in a warning letter.
Despite claims by the FDA and Centers for Medicare & Medicaid Services (CMS) that parallel review could expedite marketing of new devices, industry fears the opposite could happen, depending on how the program is implemented.
Arrow Intra-Aortic Balloon (IAB) Catheter Products: Class 1 Recall - Catheters Can Become Stuck in the SheathDecember 29, 2010 11:31 am | by U.S. Food & Drug Administration | News | Comments
Arrow Intra-Aortic Balloon (IAB) catheters can become stuck in the sheath and potential to cause delay in therapy, bleeding or arterial injury.
Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials - Recall Due to Particulates in Some VialsDecember 29, 2010 4:31 am | by U.S. Food & Drug Administration | News | Comments
Nationwide recall initiated December 23 due to some vials of these lots contain particulates.
Federal Register: Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for Voting and/or NV Consumer Repre...December 28, 2010 6:34 am | by U.S. Food & Drug Administration | News | Comments
The FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing.
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third Party Review Program...(2)December 28, 2010 6:31 am | by U.S. Food & Drug Administration | News | Comments
Section 210 of the FDAMA established section 523 of the FD&C Act (21 U.S.C. 360m), directing FDA to accredit persons in the private sector to review certain premarket notifications (510(k)s). Participation in this third-party review program by...
Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of MeetingDecember 27, 2010 4:30 am | by U.S. Food & Drug Administration | News | Comments
On January 25, 2011, the committee will discuss and make recommendations regarding regulatory classification of Automated External Defibrillators to either reconfirm to class III (subject to premarket approval application (PMA)) or reclassify to class...
Product marketed as a dietary supplement contains sibutramine, a controlled substance known to substantially increase blood pressure and/or pulse rate, and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Product marketed as dietary supplement contains undeclared analogue of sildenafil, a drug which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
Questions and answers about Abbott Diabetes Care to recall 359 different lots of glucose test strips
The U.S. Food and Drug Administration today announced the agency is working with Abbott Diabetes Care to recall 359 different lots of glucose test strips