Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney ImpairmentSeptember 1, 2011 12:31 pm | by U.S. Food & Drug Administration | News | Comments
Reclast should not be used in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment.
Reports of hypersensitivity reactions, including anaphylaxis (a life-threatening allergic reaction), angioedema, low blood pressure, rapid heart rate, swollen tongue, difficulty breathing, wheezing, or rash.
CDRH Learn (Spanish): 510(k) Third Party Review Online Video Presentation and Printable Slide PresentationAugust 30, 2011 11:31 am | by U.S. Food & Drug Administration | News | Comments
510(k) Third Party Review Online Video Presentation and Printable Slide Presentation in Spanish
Fears of hackers compromising implantable devices are unfounded, industry says.
Competitive bidding will widen to the national stage for federal purchases of durable medical equipment (DME) and prosthetics, orthotics and supplies, the Centers for Medicare & Medicaid Services (CMS) said Friday.
The ShoulderFlex Massager, distributed by King International in Beaverton, OR, is a personal massage device designed for home use to provide deep tissue massage to the neck, shoulder and back while the user lies on a flat surface.
Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High DosesAugust 24, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments
Citalopram should no longer be prescribed at doses greater than 40 mg per day.
The FDA is announcing a Workshop to facilitate medical device innovation with the focus on tissue adhesive materials. In the last 20 years there has been an explosion in the number of biomaterials being used as adhesives. There is incredible variation..
Labeling, Approval Order, and Summary of Safety and Effectiveness for Propel? (P100044).
The Propel sinus implant is a temporary, self-absorbing implant designed to keep the spaces within and around the sinuses open following sinus surgery. The Propel sinus implant is manufactured from a synthetic material which is absorbed by the body over 4
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for June 2011.
Draft Guidance for Industry and Food and Drug Administration Staff - Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic ActAugust 16, 2011 5:31 am | by U.S. Food & Drug Administration | News | Comments
Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (the act) is one means by which the FDA can obtain additional safety and/or effectiveness data for a device after it has been cleared through the premarket...
CDRH is pushing a proposal to increase the use of registries to help meet device postmarket surveillance requirements.
The FDA is considering requiring quality agreements between medical product manufacturers and their suppliers as part of its push for tighter control of the supply chain, an FDA consumer safety officer says.
The FDA on July 19, 2011 announced it is seeking input on its oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications (apps) that are designed for use on smartphones and other mobile...
Public Meeting - Recommendations Proposed in Institute of Medicine Report: Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years, Septembe...August 12, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments
The purpose of the meeting is to encourage public comment on the recommendations proposed in the Institute of Medicine (IOM) report.
FDA provided an update of FDA?s discussions with Industry, including details regarding the July 15, 2011 meeting with Industry. FDA noted that the Agency had also met with Industry again on July 26, 2011. FDA answered questions from stakeholders...
FDA / NHLBI / NSF Workshop on Computer Methods for Medical Devices: Validation of Computer with Nonclinical Models, September 7-9, 2011August 11, 2011 5:32 am | by U.S. Food & Drug Administration | News | Comments
The meeting will be held on September 7-9, 2011 from 9:00 a.m. to 5:00 p.m. and an optional session (see agenda) will be held on September 6, 2011 from 1:00 p.m. - 5:30 p.m.
This letter is to notify you of the fiscal year 2012, (October 1, 2011-September 30, 2012), fee rates and payment procedures for medical device user fees payable to the United States Food and Drug Administration, (US FDA).
Some vials may not maintain potency throughout their shelf-life, which may lead to reduced effectiveness.
GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH): Class I RecallAugust 3, 2011 12:30 pm | by U.S. Food & Drug Administration | News | Comments
HCH device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient.
Reports of breakage and/or separation of the stylet.
Class I Medical Device Recall: Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis CatheterAugust 3, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments
Arrow International Inc. received complaints indicating breakage and/or separation of the stylet within the Arrow NextStep Antegrade Catheters.
To provide context for FDA's proposed approach to mitigate program uncertainties and advance negotiations, FDA started by summarizing the status of where MDUFA reauthorization discussions stand. From January through April, FDA provided more data and...
Summary Information for: VITROS Immunodiagnostic Products Anti-HBe Reagent Pack, VITROS Immunodiagnostic Products Anti-HBe Calibrator, and VITROS Immunodiagnostic Products Ant...August 1, 2011 9:32 pm | by U.S. Food & Drug Administration | News | Comments
Labeling, Approval Order, and Summary of Safety and Effectiveness for VITROS Immunodiagnostic Products Anti-HBe Reagent Pack, VITROS Immunodiagnostic Products Anti-HBe Calibrator, and VITROS Immunodiagnostic Products Anti-HBe Controls (P100001).