Cepheid today announced it has received market authorization from the U.S. Food & Drug Administration (FDA) for its Xpert MTB/RIF test. The review decision was based on the de novo 510(k) review process, which allows novel products without predicates to be down-classified and brought to market.
EnteroMedics Announces PMA Application for VBLOC Therapy in Obesity Accepted for Review and Filing by FDAJuly 25, 2013 4:03 pm | by The Associated Press | News | Comments
EnteroMedics Inc., the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that the U.S. FDA has accepted for filing the Company's Premarket Approval application for approval of the Maestro® Rechargeable System's VBLOC® vagal blocking therapy as a treatment for obesity.
The FDA puts its highest-risk label on a recall of programmable infusion pumps made by Codman & Shurtleff Inc., a division of Johnson & Johnson subsidiary DePuy Orthopaedics. Codman's implanted MedStream pumps were recalled over a potential defect in a component that measures the contents of the pump reservoir.
Since June 2009, all drug listing submissions have been done electronically using Structured Product Labeling (SPL) files. Now, devices can be listed using SPL as well. While the FDA does not require that devices be listed using SPL, the ability to do is there, with benefits including providing product exposure on sites such as the National of Library of Medicine’s (NLM) DailyMed.
As a manufacturer, the UDI rule allows us to take more than 30 years of experience in the development of marking and imaging technologies to satisfy a critical need in a new market. In terms of assisting our customers in their efforts to become compliant, we now offer the MPX-90M impact printer.
The FDA UDI rule will standardize the way the medical device industry identifies its products, which is a foundational step toward utilizing companies who offer higher value, more complex solutions. Engaging these solutions is critical to helping manufacturers secure supply chains, deter counterfeiting, and ensure patients have access to safe medical devices.
In reference to the UDI rule, the FDA estimates more than 1,200 companies are in need of equipment or have already implemented direct part marking into production. Of the 1,200 companies, roughly 700 are medical implant manufacturers, while the remaining 500 produce multi-use devices, such as surgical instruments.
The following standard must be met for all medical products intended to be used in the home: IEC 60601-1-11, which is “Medical Electrical Equipment—Part 1-11: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment.”
While regulators are understandably focused on compliance, industry needs to focus on quality. The terms are often used interchangeably, but there’s a big difference between quality and compliance. Think of quality as the processes, procedures, and culture that permeate an organization—enabling it to consistently develop and produce high-quality medical device products that will meet or exceed regulatory requirements.
Digital Angel Corporation, following its recent share exchange with VeriTeQ Acquisition Corporation, announced that VeriTeQ filed a provisional patent with the U.S. Patent and Trademark Office in September 2012 for a microchip that is able to withstand high temperatures in order to make it compatible with the sterilization processes involved in the manufacturing of implantable medical devices.
The IEC has made a change to the Recovery Test, 60601-2-34. Issue 3 offers modifications that make it more beneficial for engineers as a custom test system is no longer required for this specific test. This article reviews the full breadth of the test and how it can impact medical device manufacturers.
House GOP-ers are looking to rewrite the so-called "doc fix," replacing Medicare's sustainable growth rate fomula with a physician performance incentive program. The 70-page proposal claims to improve quality and efficiency in the healthcare system with a physician reimbursement system that would start with 5 years of consistent Medicare payments.
Lawmakers on Capitol Hill have floated a proposal to protect user fees paid by medical device and drug companies to the FDA from federal budget cuts forced by sequestration. In March, the federal watchdog agency lost $210 million, or about 5.1% of its $4.1 billion 2013 budget, as a result of sequestration, a bargain between the White House and Congress.
ValveXchange has its sights set on winning regulatory approval in Europe for its Vitality device, a product the company touts as the 1st serviceable bioprosthetic heart valve. Clinical trial enrollment to support European CE Mark approval wrapped up last month, and ValveXchange submitted all of its paperwork to the regulatory body DERKA Certification this week, according to a press release.
President Barack Obama says his healthcare law is working and cutting costs for consumers, despite what the law's Republican critics say. At the White House Thursday, Obama emphasized half a billion dollars in rebates going to nearly 9 million people under a provision of the law he says is holding insurance companies accountable.
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.