Disagreements are inevitable in science, medicine – and even life. As part of a regulatory agency committed to public health, the FDA's medical devices center occasionally confronts scientific and policy disagreements among our staff and with the various stakeholders we strive to serve.
Device manufacturers need to ensure their product will be sufficiently cleaned by healthcare professionals. This article will focus on the areas of the FDA’s guidance document that are causing difficulties in cleaning validations, and will demonstrate how pre-validation laboratory work can help save time and money.
The U.S. Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. When used as part of a complete medical and psychological examination, the device can help confirm an ADHD diagnosis.
The 2.3% medical device sales tax has cost the industry an estimated $1 billion so far, according to a report released by a coalition of medical device lobbying groups, which called the milestone "frightening."The tax costs medical device makers an average of $194 million per month, funds which should be going to research & development efforts and to salaries for new employees...
While legal enforcement dates for RoHS2 compliance is July 22, 2014, Northwire, a leading OEM, is alerting their valued customers in medical equipment manufacturing of the critical details to make certain they comply with CE-mark. Originally published in July 2011, the Recast RoHS Directive dictates that all medical devices, electrical and electronic OEMs comply with new standards.
As a consequence of the Affordable Care Act, between 500,000 and 900,000 Americans may choose to stop working. That possibility is predicted in a new analysis of an analogous situation in reverse: the abrupt end of Tennessee's Medicaid expansion in 2005.
The FDA put its highest-risk label, Class I, on a recall of Medtronic's (NYSE:MDT) Paradigm insulin infusion pumps, which the medtech giant had warned about earlier this year. Medtronic Canada said last month that it received 2 reports on its Paradigm and Polyfin infusion devices, concerning the over- and under-delivery of insulin therapy.
VeriTeQ’s Patented and FDA Cleared Technology Can Help Medical Device Manufacturers Comply with FDA Proposed Rule for Unique Device Identification – Direct Mark RequirementJuly 15, 2013 8:00 am | by Business Wire | News | Comments
Digital Angel Corporation has announced that the patented VeriTeQ “Q Inside” radio frequency identification (“RFID”) microchip, cleared by the U.S. Food and Drug Administration (“FDA”), can help implantable medical device manufacturers comply with the FDA’s Proposed Rule for Unique Device Identification (“UDI”) – Direct Mark requirement.
The American Association for Homecare warned today that the controversial Medicare bidding program for diabetic testing supplies is endangering beneficiaries by requiring the use of generic testing strips and monitors that are under scrutiny by physicians and the Food and Drug Administration for inaccurate readings.
Putting medical devices on the network provides a large number of benefits, such as supporting telemedicine and the easy transfer of test results to electronic medical records (EMR) systems. However, putting these devices on a network also introduces a number of risks.
Since its launch last month, House Majority Leader Eric Cantor's (R-Va.) Citizen Cosponsor website has listed nearly 3,000 bills, among them "Protect Medical Innovation Act of 2013," a measure to repeal the 2.3% medical device tax that took effect at the start of this year.
Halt Medical Announces New CPT® Code From the American Medical Association for RF Ablation of Uterine FibroidsJuly 10, 2013 3:00 am | by PR Newswire | News | Comments
Halt Medical is very pleased to announce that the American Medical Association (AMA) Current Procedure Terminology (CPT) Panel has established a new CPT® code specifically for Radiofrequency (RF) Ablation of Uterine Fibroids. CPT codes are used by medical practitioners; including physicians, hospitals, and other healthcare providers to report healthcare services to insurers for the purpose of reimbursement.
Retina Implant AG has announced that its wireless subretinal implant technology, the Alpha IMS, has received CE Mark. Retina Implant's technology, which has been in clinical trials across the world since 2005, is designed to restore useful vision in patients blinded by the degenerative eye condition retinitis pigmentosa.
Medical device industry lobbying groups rallied behind Sen. Max Baucus (D-Mont.) and Rep. Dave Camp (R-Mich.) as the Congressional duo embarked on a nation-wide tax reform tour, a possible boon to efforts to repeal the medical device tax.
Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), released the following statement in response to tax-writing committee Chairmen Camp and Baucus as they begin their nationwide listening tour in favor of a simpler, fairer U.S. tax code.
In close collaboration with leading clinicians in the field of minimally-invasive medicine, Philips has been driving innovation in interventional imaging for more than 50 years, helping to guide procedures such as the catheter-based treatment of obstructed coronary arteries, brain aneurysms, heart rhythm disorders and defective heart valves.
The FDA recommended bumping blood access devices down from Class III to Class II regulatory status, based on mounting evidence that these implanted tubes, catheters and cannulae belong in a lower-risk category. The federal watchdog agency said there's enough safety and efficacy data to peel off a layer of regulatory oversight.
The FDA this month issued a rule that would keep confidential certain records pertaining to investigations into potential researcher misconduct at the National Institutes of Health, exempting such documents from federal Privacy Act requirements.
Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Reporting for ManufacturersJuly 8, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments
This draft guidance document describes and explains the Food and Drug Administration’s current regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events.
CorMedix has announced that it has received CE Mark approval for Neutrolin, a catheter lock solution, for patients with central venous catheters on hemodialysis secondary to advanced chronic kidney disease. The Neutrolin solution includes an anti-coagulant and broad-spectrum antimicrobial combination that is active against common microbes.
One of the greatest pleasures I have as FDA commissioner is the opportunity to meet with so many who are making a real difference in the world of health care, including researchers, doctors, drug industry leaders, foundations, and advocates for patients and families, including most recently the Alexandria Summit for Oncology.
Under fire for being too lenient with medical device approvals, European regulators proposed an update to current CE Mark review and approval practices. Specifically, the European Commission's proposed changes address the relative ease with which companies can secure CE Mark approval by "shopping" for an agency in a specific country that will most quickly green-light a new device.
Minnesota medical device giant Medtronic (NYSE:MDT) confirmed today that it recalled certain of its already-troubled Infuse spinal fusion surgery kits after learning of possible contamination in sponges manufactured by Integra Lifesciences.
Class I Medical Device Recall: Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps - Failure of Priming BolusJune 28, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments
The SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps (SynchroMed Implantable Infusion Pumps) contain and administer prescribed drugs to a specific site inside the patient’s body. Currently, the approved drugs for use with the SynchroMed Infusion Pump are Infumorph, Lioresal, Prialt (Ziconotide), Floxuridine, Methotrexate and Gablofen.
Class I Medical Device Recall: Medtronic Sutureless Connector Intrathecal Catheter Products ? Catheter OcclusionJune 28, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments
The Sutureless Connector Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion, which is the blockage or stoppage of drug flow due to misalignment at the point where the catheter connects to an implantable pump. Medtronic is removing all unused products that were manufactured with the previous design.