Antipsychotic drugs: Class Labeling Change - Treatment During Pregnancy and Potential Risk to NewbornsFebruary 22, 2011 6:32 am | by U.S. Food & Drug Administration | News | Comments
Risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs.
The FDA has down-classified medical device data systems (MDDS) from Class III into Class I via a final rule, which could help manufacturers compete with IT companies in this area.
Quality problems with metal-on-metal (MoM) hip replacement systems, like Johnson & Johnson (J&J)’s ASR devices, may not be as widespread as UK data indicates, the FDA says.
Potential for serious maternal heart problems and death.
Recall due to pocket fills may result in patient harm, serious injury, and/or death due to drug overdose or underdose.
These test strips may give falsely low glucose results. False results may lead patients or health care providers to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of a false, low reading...
Reason for Recall: This product may not be sterile. Patients, who are immuno-compromised, such as those with diabetes, cancer and certain other chronic diseases, may be at potential risk for infection.
Today, the FDA announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or...
An FDA inspection of Tra & Accessories found failures in its control of design, purchasing and the warehouse environment for products, resulting in a warning letter.
Rep. Rosa DeLauro (D-Conn.) is “strongly urging” CDRH to hold an advisory committee meeting to release all available information on 10-year postmarket study results for saline breast implants and address issues with FDA oversight of the trials.
Hip joint deterioration can lead to symptoms such as pain, stiffness or difficulty walking. When symptoms do not respond to conservative treatment, patients may be advised to undergo total hip replacement or hip resurfacing...
Use of recalled product may lead to patient harm.
The report proposes potential actions for FDA's CDRH to facilitate the development, assessment, and regulatory review of innovative medical devices.
FDA is seeking input on a number of identified challenges associated with incentivizing innovation, and the proposed solutions. In addition, the Agency requests comments on the Innovation Pathway proposed under the report.
Public Workshop - Center for Devices and Radiological Health's Innovation Initiative, March 15, 2011February 8, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments
The purpose of the public workshop is to solicit public feedback on select actions outlined in CDRH's Medical Device Innovation Initiative (report). FDA is seeking input on a number of identified challenges associated with incentivizing innovation, and...
CDRH recognizes that transformative innovative devices typically present new scientific and regulatory challenges. The Innovation Initiative supports the development of innovative products by addressing some of the barriers that can impede a product's...
Hydrocodone Bitartrate And Acetaminophen Tablets, Phenobarbital Tablets by Qualitest: Recall - Incorrect Package LabelingFebruary 7, 2011 9:30 am | by U.S. Food & Drug Administration | News | Comments
Patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital, which can lead to serious adverse events.
Some vials exhibit translucent visible particles consistent with glass delamination.
The FDA has issued a draft guidance on the required content and format of applications for the drugs used in positron emission tomography (PET) diagnostic scans.
Two institutional review boards (IRBs) have received warning letters for failure to follow written procedures and maintain member quorums during clinical trials for devices.
Use of recalled product may lead to arterial injury, hemorrhaging, blood clots (thrombosis), or other serious events.
Federal Register: Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public WorkshopFebruary 4, 2011 5:30 am | by U.S. Food & Drug Administration | News | Comments
This 2-day public workshop is intended to provide information about FDA drug and device regulation to the regulated industry.
B. Braun Outlook 400ES Safety Infusion System, Model Number 621-400ES: Class I Recall - Hardware May Become UnresponsiveFebruary 2, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments
Software update may cause normal operation to stop with no visual warning signal.
Labeling, Approval Order, and Summary of Safety and Effectiveness for Arctic Front CryoCatheter System (P100010).
Labeling, Approval Order, and Summary of Safety and Effectiveness for LifeStent and LifeStent XL Vascular Stent (P070014S010).