Devicemakers may flee overseas if the U.S. implements a recently enacted tax on prescription devices, AdvaMed says. The nation could lose thousands of device industry jobs and see demand shrink for products whose cost rises as a result of the excise tax, according to a report the trade...
FDA device regulators would get marginally more money in fiscal 2012 than in fiscal 2011, but nearly $7 million less than the agency sought.
Meeting Materials for the Obstetrics and Gynecology Devices Panel Meeting held on September 8-9, 2011September 9, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments
The Obstetrics and Gynecology Devices Panel reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including clinical and molecular genetics...
The purpose of this follow up letter is to provide specific recommendations to facilitate the FDA import entry review process for medical and non-medical radiation-emitting electronic products.
Tumor Necrosis Factor-alpha (TNF & alpha;) Blockers: Label Change - Boxed Warning Updated for Risk of Infection from Legionella and ListeriaSeptember 7, 2011 10:30 am | by U.S. Food & Drug Administration | News | Comments
Patients treated with TNF? blockers are at increased risk for developing serious infections.
MECHANICAL ventilators provide essential respiratory support to critically ill patients in healthcare facilities, in homes, and during patient transport. Providing care to patients requiring mechanical ventilation can be challenging due to factors such...
PMAs for silicone gel-filled breast implants should be revoked if manufacturers don’t improve post-approval study follow-up, consumer advocates and a former FDA official told an agency advisory panel.
Devicemakers and the FDA remain divided on the terms of Medical Device User Fee and Modernization Act (MDUFMA) reauthorization as the deadline approaches for resolving differences.
CDRH Learn (Spanish): Overview of Regulatory Requirements: Medical Devices - Video, slides, transcriptSeptember 2, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments
Online training though video presentation, slide presentation on medical device regulatory requirements
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.