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FDA considers patient preference on benefit-risk trade-offs in medical devices

July 30, 2013 1:29 pm | by Mass Device | News | Comments

The FDA is looking to make some updates to its medical device benefit-risk calculations, taking into greater consideration the preferences of patients, caregivers and healthcare workers. The federal watchdog agency is holding a public workshop to solicit suggestions on how its medical device review arm might better assess and incorporate patient perspectives on "meaningful benefits" and "appropriate risks" of new medical devices.

IntelligentMDx Receives FDA Clearance for IMDx VanR for Abbott m2000 assay

July 29, 2013 4:41 pm | by PR Newswire | News | Comments

IntelligentMDx (privately held) announced today that the U.S. Food and Drug Administration (FDA) has cleared its automated molecular diagnostic test that detects the presence of vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE).

Public Workshop - The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Processes, September 18-19, 2013

July 29, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The purpose of this workshop is to discuss ways to incorporate patient preferences on the benefit-risk trade-offs of medical devices into the full spectrum of the Center for Devices and Radiological Heath (CDRH) regulatory decision making. It also aims...

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Class I Medical Device Recall: GE Healthcare Nuclear Medicine Systems

July 29, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: GE Healthcare became aware of an incident at a VA Medical Center facility in the US. A patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. On July 03, 2013 GE notified hospitals...

Panasonic to Sell Part of Healthcare Business

July 26, 2013 11:49 am | by The Associated Press | News | Comments

Panasonic said Friday it will sell its ultrasonic diagnostic equipment business to Konica Minolta Inc. in January 2014 as part of efforts to improve its financial base eroded by the firm's recent sluggish performance.     

Teaching Old Drugs New Tricks

July 26, 2013 9:52 am | by Cambridge Consultants | News | Comments

Innovative product development and technology consultancy firm Cambridge Consultants has collaborated with Clinigen Group to create a new way of identifying fresh market applications for drugs nearing the end of their product lifecycle.

Cepheid Receives FDA Market Authorization for Xpert MTB/RIF

July 25, 2013 5:29 pm | by PR Newswire | News | Comments

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 FDA

July 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.

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Johnson & Johnson subsidiary gets Class I recall for implantable infusion pumps

July 25, 2013 11:29 am | by Mass Device | News | Comments

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.

Best Practices for and Common Pitfalls in Creating Device Listing Files

July 24, 2013 2:32 pm | by Howard Shatz, SPL and ACA 6004 Project Manager, Data Conversion Laboratory | Articles | Comments

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.

Addressing UDI Compliance with Direct Printing

July 23, 2013 5:10 pm | by Rachel Hammer, Product Manager, Roland DGA Corp. | Roland DGA Corporation | Blogs | Comments

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’s UDI Rule Is Coming…Ready?

July 23, 2013 5:05 pm | by Scott Pugh, Vice President, Solution and Service Innovation, Verify Brand | Verify Brand, LLC | Blogs | Comments

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.

Lasers Address UDI Needs

July 23, 2013 4:57 pm | by Thomas Burdel, National Sales Manager TruMark, TRUMPF | Blogs | Comments

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.

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‘Standards’ for Home Healthcare

July 23, 2013 4:44 pm | by Todd Konieczny, Assistant Chief Engineer, Americas Region; Technical Manager, Medical Division, Intertek | Blogs | Comments

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.”

Renew Focus on Quality in Medical Device Manufacturing

July 23, 2013 4:34 pm | by James Pink, Partner, NSF Medical Devices, Part of NSF International’s Health Sciences Division | Articles | Comments

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.

Temperature-Resistant Microchip to be Used for UDI Compliance for Implantables

July 23, 2013 8:30 am | by Business Wire | News | Comments

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.

IEC 60601-2-34 Issue 3: Changes to Recovery Test

July 22, 2013 2:11 pm | by Jeff Lind, CEO & Jose Cabanillas, Hardware Engineer, Compliance West USA | Compliance West USA | Articles | Comments

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.

GOP forwards a new ‘doc fix’ for Medicare payments

July 22, 2013 7:29 am | by Mass Device | News | Comments

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.

Congress: House bill seeks to shield user fees from sequester with FDA S.O.S bill

July 18, 2013 4:47 pm | by Mass Device | News | Comments

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 applies for EU approval of a 2-part transcatheter valve

July 18, 2013 12:29 pm | by Mass Device | News | Comments

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.

Obama Talks Up Healthcare Law's Rebates

July 18, 2013 12:08 pm | by Darlene Superville, Associated Press | News | Comments

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.

Resolving disputes concerning FDA and medical devices

July 17, 2013 9:34 am | by Mass Device | News | Comments

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.

Using Notebook Studies to Help Ensure a Successful Reusable Device Cleaning Validation

July 16, 2013 2:34 pm | by Patrick Kenny, Director of Analytical Services, Microtest Laboratories | Microtest Laboratories, Inc. | Articles | Comments

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.

Brain Wave Test Device for ADHD

July 16, 2013 9:51 am | by U.S. Food and Drug Administration | News | Comments

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.

FLASH: Medical device tax payments hit the $1B mark

July 15, 2013 4:29 pm | by Mass Device | News | Comments

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...

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