The potential for hacking into software-operated medical devices could pose a serious patient safety risk, a board convened by the National Institute of Standards and Technology (NIST) maintains.
Stakeholders agree on the majority of the Medical Device User Fee Act (MDUFA) reauthorization legislation now before Congress, but that didn’t make a House health subcommittee hearing on device and drug user fees smooth sailing.
Risk of renal impairment, hypotension, and hyperkalemia with concomitant use of aliskiren with angiotensin receptor blockers (ARBs) or angiotensin converting enzyme inhibitors (ACEIs) in patients with diabetes.
Other?Sonic Generic Ultrasound Transmission Gel: Safety Communication - Risk of Bacterial ContaminationApril 18, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments
Exposure to contaminated product may lead to serious infections.
WASHINGTON, D.C. - Congressman Edward J. Markey (D-Mass.), a senior member of the Energy and Commerce Committee, which has jurisdiction over the Food and Drug Administration (FDA), issued the following statement after the Subcommittee on Health hearing on the discussion...
Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject by Hospira, Inc: Recall - May Contain More Than Intended Fill VolumeApril 18, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments
Consequences of opioid pain medication overdose can be life-threatening, including respiratory depression (slowed breathing or suspension of breathing), and low blood pressure.
These reagents are used with the Abbott ARCHITECT Instrument System to identify certain virus proteins associated with hepatitis B virus (HBV). If these virus proteins are present, then the patient is likely to be infected with HBV.
Labeling, Approval Order, and Summary of Safety and Effectiveness for ARCHITECT HBsAg (P110029).
Harry and David Issues Allergy Alert on Undeclared Peanuts in Harry & David Premium Kansas City Style Barbeque AlmondsApril 13, 2012 8:31 pm | by U.S. Food & Drug Administration | News | Comments
Harry and David, is voluntarily recalling approximately 205 2 oz. bags labeled Harry & David Premium Kansas City Style Barbeque almonds, because the bags may contain peanuts. Peanuts are not declared as ingredients, but the label includes the statement "May contain trace amounts of...
• Moon Marine USA Corporation (also known as MMI) of Cupertino, Calif. is voluntarily recalling 58,828 lbs of a frozen raw yellowfin tuna product, labeled as Nakaochi Scrape AA or AAA. Nakaochi Scrape is tuna backmeat, which is specifically scraped off from the bones, and looks like a...
An FDA advisory panel unanimously recommended approval of a new tool for detecting breast cancer, but advised against Class I status for a preamendment device used for the same purpose.
The FDA and other agencies must provide expertise, training and tools to developing nations to improve their medical technology monitoring practices and prevent dangerous medical products from entering the U.S., according to an Institute of Medicine (IOM) report. The recommendation is one...
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for February 2012.
Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clotsApril 10, 2012 10:31 am | by U.S. Food & Drug Administration | News | Comments
Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.
CDRH Learn (New Module - Factors to Consider When Making Benefit-Risk Determinations in Medical Device PMA and De Novo Classifications)April 10, 2012 6:30 am | by U.S. Food & Drug Administration | News | Comments
This guidance document was developed to identify and clarify the factors FDA considers when making benefit-risk assessments in PMA applications, and de novo classification petitions for medical devices.
Recent agency data show CDRH making slow but steady progress toward several strategic goals — but missing the mark on the Medical Product Safety Network (MedSun) initiative.
The senators who co-authored the Physician Payments Sunshine Act are trying once more to exercise their legislative oversight — this time setting a June deadline for overdue implementation of the rules.
Guidance for Industry and Food and Drug Administration Staff - User Fees for 513(g) Requests for InformationApril 6, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments
Title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA), also termed the Medical Device User Fee Amendments of 2007, P.L. 110-85, extends FDA?s authority to collect medical device user fees by establishing a fee for ?a request for...
Guidance for Industry and Food and Drug Administration Staff - FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmet...April 6, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments
The purpose of this guidance is to establish procedures for submitting, reviewing and responding to requests for information regarding the class in which a device has been classified or the requirements applicable to a device under the Federal Food, Drug,
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (June 21, 2012)April 4, 2012 9:31 pm | by U.S. Food & Drug Administration | News | Comments
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS): Class 1 Recall- Outflow Graft May Kink or DeformApril 4, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments
May result in reduction of blood flow from the pump, pump/graft thrombosis, or perforation of the outflow graft.
Class I Medical Device Recall: Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS)April 4, 2012 9:31 am | by U.S. Food & Drug Administration | News | Comments
Detachment of the bend relief from its intended position around the proximal outflow graft may allow the graft to kink or deform, resulting in reduction of blood flow from the HeartMate II LVAS pump, pump/graft thrombosis, or perforation of the outflow...
The counterfeit product may have resulted in patients not receiving needed therapy.
Stryker’s Wingspan stent could be yanked from the market if the FDA heeds March 23 recommendations of its Neurological Devices Panel.
CDRH would move into a “death spiral” if Medical Device User Fee Act (MDUFA) legislation is not reauthorized this summer, director Jeffrey Shuren warned at a Senate Health, Education, Labor & Pensions (HELP) committee hearing Thursday.