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Battle Lines Being Drawn Over LDT Regulation

December 15, 2014 9:54 am | by Richard Park, Contributing Editor | Blogs | Comments

“The heart of Bradley Thompson’s argument rests on, ‘if a company is manufacturing an IVD test, the agency has full authority.’ Developing and performing most LDTs is not ‘manufacturing’ in a recognized sense of the word and never has been (although...

A Delicate Balance: How Can We Rightsize Treatment Costs?

December 12, 2014 10:43 am | by TEDMED | Videos | Comments

It’s a familiar idea: the price of a product is whatever the market will bear - the highest...

Using Smartphone Cameras as Test Strip Reading Devices

December 12, 2014 7:30 am | by Thomas M. Tsakeris, President, Devices and Diagnostics Consulting Group | Blogs | Comments

In my experience as a regulatory consultant mainly in the IVD area, I have observed over...

Implementation of the UDI System Is Critical to Public Health

December 10, 2014 10:33 am | by Jeffrey Shuren, M.D., Director, CDRH | Blogs | Comments

As the FDA works with manufacturers to launch a new system of identifying medical devices using...

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Stryker Will Pay About $80M to End Investigation

December 9, 2014 11:46 am | by The Associated Press | News | Comments

The medical device maker Stryker will pay about $80 million to end a federal investigation into its acquisition of a company that the U.S. said was marketing a product that hadn't been approved by regulators. The company said that the U.S...

Addressing the Top Five Software Validation Questions

December 9, 2014 9:48 am | by Penny Goss, Consultant, Penny Goss Technical Solutions | Articles | Comments

The FDA (Food and Drug Administration) and IEC (International Electrotechnical Commission) requirements for validation of manufacturing and quality system software can conjure up a lot of questions. Understanding the actual guidelines and best...

Medical Device Makers: You’re Responsible for Device Cybersecurity

December 8, 2014 11:06 am | by AAMI | News | Comments

Who is responsible for the cybersecurity of medical devices? The makers of those devices. That anyway is the position of the American Hospital Association (AHA), which made its point in comments submitted to the U.S. Food and Drug Administration...

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Exploit Opportunities Offered by UDI Initiative

December 8, 2014 7:30 am | by Dave Taylor, Vice President, Global Products, PRISYM ID | Blogs | Comments

Sep. 24 saw the first UDI compliance deadline which means that organizations should now be focusing on the implementation phase, following a thorough preparation phase reviewing all current processes and systems in place. The implementation...

Trust, But Verify In Order to Comply with UDI

December 5, 2014 7:30 am | by Steve Cochran, Chief Technology Officer, GHX | Blogs | Comments

“Trust, but verify” is my advice to manufacturers seeking to comply with the UDI rule. As a third party submitter that has successfully loaded data into the Global UDI Database (GUDID), I can confidently tell manufacturers, "trust that it...

Develop an Internal Team for UDI

December 4, 2014 7:30 am | by Deborah Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions | Blogs | Comments

Working with industry, we still see a need for more internal conversations among various stakeholders within organizations for an effective rollout of UDI. This is because the regulation has “amended” many existing regulations that will impact...

Green Light from FDA for CT Lung-Imaging Software

December 3, 2014 11:08 am | by University of Michigan Health System | News | Comments

A technology that started in a University of Michigan Medical School lab may soon help lung disease patients around the world breathe a little easier, by helping their doctors make a clearer diagnosis and more individualized treatment plan. Imbio...

Roll-Out UDI to the Device Manufacturer and Supply-Chain Partners

December 3, 2014 7:30 am | by Matt Kelly, Key Account Manager, Medical, Watlow | Blogs | Comments

The Food and Drug Administration (FDA) has released a final rule requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI. A UDI system has the potential to improve the quality of...

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Have A Solid Team in Place for UDI Compliance

December 2, 2014 7:30 am | by Linda Chatwin, Esq, RAC Manager, Medical Regulatory Advisory Services North America, Life and Health, UL LLC | Blogs | Comments

Preparing for UDI requires a well-thought through project plan. Someone in the organization needs to own the project and manage it carefully, or bring in outside resources to help. The key to success lies in examining current labeling processes...

Survey: UDI Compliance Poses Significant Challenge

December 1, 2014 10:37 am | by PRISYM ID | News | Comments

A recent survey of medical companies in Europe and North America has identified some of the key issues for packaging and labeling operations in the complex and changing medical device market. The survey, carried out by PRISYM ID, a leading...

Lab Group Hires Lawyers for LDT Fight

December 1, 2014 9:23 am | by Richard Park, Contributing Editor | Blogs | Comments

The American Clinical Laboratory Association (ACLA) has retained former Solicitor General Paul D. Clement, a partner with Bancroft PLLC, and Laurence H. Tribe, the Carl M. Loeb University Professor and Professor of Constitutional Law at Harvard University...

Can Public-Private Partnerships Change the Healthcare Game?

November 26, 2014 1:49 pm | by TEDMED | Videos | Comments

The healthcare world is an ever-evolving area with countless stakeholders, all working towards improving the health of the population. But with different priorities and different ways of working, how can diverse stakeholders work together most effectively?...

A MedTech Thanksgiving Tale

November 26, 2014 8:30 am | by Sean Fenske, Editor-in-Chief | Blogs | Comments

Not so long ago, the collective nations of the medtech Native Americans co-existed in relative peace in a land far from all others. Sure, there was the occasional squabble between tribes, while other times, one tribe would absorb a smaller tribe into...

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Cancer Device Gets Stronger Warning from FDA

November 24, 2014 11:58 am | by The Associated Press | News | Comments

U.S. regulators have strengthened their warning against use of a once-popular device for gynecologic surgery that can spread unsuspected cancer, saying its risk is only justified in a fraction of patients. The Food and Drug Administration is updating...

Converging Medical Device, Drug, and Biotech Companies

November 21, 2014 7:30 am | by Michael Drues, Founder & President, Vascular Sciences | Blogs | Comments

Most device development is evolutionary, (i.e., come out with one device, tweak it a bit to make a new device, etc.) I understand the advantages of evolutionary device development from a technology perspective, from a business perspective...

Working More Closely With Hospital Systems and Payers

November 20, 2014 7:30 am | by Michael Pereira, Senior Vice President of Technology & Operations, Ximedica | Ximedica | Blogs | Comments

Innovations are occurring from multiple paths, all fueled from a consumerization of the medical industry. Our expectations as patients, or as clinicians, or even as payers are changing what is acceptable coming from the medical device industry...

Preventing and Reducing Hospital Admissions

November 19, 2014 7:30 am | by Marc Dubreuil, Vice President of Business Development, Farm Design | Blogs | Comments

We are beginning to see more integration of capabilities in order to provide imaging, diagnostics, and tissue manipulation within a single device and procedure. This allows the clinician, after confirming suspicious tissue, to biopsy, ablate...

Search History for 'Lessons Learned'

November 18, 2014 7:30 am | by Deborah Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions | Pilgrim Quality Solutions | Blogs | Comments

Increased quality and regulatory oversight, increased demand from an aging population and reduced reimbursements are realities for medical device companies. The Medical Device industry will have to focus on reducing costs in the product...

Assessing the Good and the Bad in the LDT Guidances

November 17, 2014 2:35 pm | by Richard Park, Contributing Editor | Blogs | Comments

FDA recently released two draft guidances on the regulation of laboratory-developed tests (LDT): Framework for Regulatory Oversight of LDTs and FDA Notification and Medical Device Reporting for LDTs. With the release of these guidances, the agency...

4 Questions to Ask when Considering the Cloud ERP Solution

November 12, 2014 7:30 am | by Bart Reitter, Director, QAD Life Sciences | Blogs | Comments

As a Medical Device manufacturer, you’ve undoubtedly heard and read the buzz about the cloud. The cloud, by definition, is a nebulous term that gets bandied about frequently these days. A simple definition of the Cloud is that it is a network...

ISO 80369 Standards on Small-Bore Tubing Connectors Inch Forward Toward Release

November 10, 2014 7:30 am | by Kyle Steele, New Product Development Engineer, Value Plastics | Value Plastics, A Nordson Company | Articles | Comments

The Luer connector has, for decades, been one of the most common types of small-bore (less than 8.5mm) connectors used in hospitals and other healthcare facilities to link or join medical devices, components, and accessories for the purpose...

Will ‘Outsiders’ Overtake the Medical Device Industry?

November 6, 2014 4:37 pm | by Sean Fenske, Editor-in-Chief | Blogs | Comments

The real variable that makes companies like Google and Apple a threat to the more established medical device players (well, besides a big bankroll) is the experience and mindset they have. These are consumer companies who have been extremely...

Developing Devices for Disabled Patients with FDA Encouragement

November 4, 2014 2:15 pm | by William Maisel, M.D., M.P.H., Deputy Center Director for Science, FDA, and Chief Scientist CDRH | Blogs | Comments

For people with disabilities, medical devices can offer a vital and potentially life-changing option. Take, for example, a patient who has had his arms amputated. Medications can treat phantom pain, but they can’t help that patient pick up a glass...

Congress Tackles LDT Regulation: The Roles of FDA v. CMS

November 3, 2014 2:03 pm | by Richard Park, Contributing Editor | Blogs | Comments

FDA recently released its two draft guidances on the regulation of laboratory-developed tests (LDT): Framework for Regulatory Oversight of LDTs and FDA Notification and Medical Device Reporting for LDTs. With the release of these guidances...

Chinese Engineer to Plead Guilty in Medical Equipment Case

October 31, 2014 12:25 pm | by The Associated Press | News | Comments

Federal prosecutors say they have reached a plea deal with a Chinese engineer charged with stealing trade secrets from a GE Healthcare subsidiary in Waukesha. The Milwaukee Journal Sentinel reports 41-year-old Jun Xie will plead guilty to ...

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