December 9, 2016

Malaysia’s MDA Releases Device, Drug Classification Criteria

New guidelines from Malaysia’s Medical Device Authority (MDA) identify four criteria for determining whether a health product qualifies as a medical device or a drug.

The four criteria are:

  • The primary intended purpose of the product;
  • The primary way the product achieves its desired purpose or effect – medical devices function by physical means, and drugs function based on pharmacological, immunological, or metabolic action;
  • The active ingredient, indication, and pharmaceutical dosage form, which are the main criteria for classifying drugs; and
  • Classification of the product or a similar product in the US, EU, Canada, Australia, and Japan.

Device and drug manufacturers also may ask the MDA for classification determinations using designated procedures.

Ireland Creates Innovation Office to Provide Regulatory Advice

Ireland’s Health Products Regulatory Agency is creating a new Innovation Office to help support development of novel products, including medical devices and technologies.

The agency stressed the importance of understanding regulatory issues early in the development process to “support a timely trajectory from product concept to market access.”

The regulator will offer a dedicated confidential online query service to be managed by a team of regulatory experts, and the office will respond to queries within 20 working days. The regulator said it would not publish the questions it receives or the responses given to maintain confidentiality.

For more information, visit: https://www.hpra.ie/innovation-office.

Applications Solicited for Single Audit Program

Additional candidate auditing organizations are invited to apply for participation in the Medical Device Single Audit Program (MDSAP) in 2017.

Starting January 1, 2017, the program will be open for applications from new candidate auditing organizations. In addition, a small number of successful applications from candidates already operating under a third-party medical device regulatory scheme will be assessed further in 2017.

The procedure for submitting an application can be found at: www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/ucm377581.htm.

Medtronic Wins CE Mark Expansion for Endurant II/IIs

The European Union expanded Medtronic’s CE Mark for Endurant II/IIs stent graft for treating abdominal aortic aneurysms.

The update includes an implantation method called ChEVAR, which utilizes an expandable balloon to increase the artery area.

This expanded indication also allows the device to be used in aneurysm patients with short aortic neck length as small as 2mm, down from 10mm previously.

Abiomed Receives Expanded FDA Approval for Heart Pump

The FDA approved Abiomed’s Impella 2.5 heart pump use in high-risk percutaneous coronary interventions.

The pump stabilizes the heart by reliving the load on the left ventricle.

The device was previously approved for treatment of ongoing cardiogenic shock immediately following heart attack or open heart surgery as a result of isolated left ventricular failure that is not responding to conventional treatment.

J&J Ordered to Cough Up $1B Over Verdict on Metal Hip Implants

J&J is charged to pay $1 billion to plaintiffs who claimed injury from the company’s metal-on-metal hip implants.

Six cases were selected out of 8,000 lawsuits filed against J&J device manufacturer, DePuy Orthopaedics, who reported injuries such as tissue death and bone erosion that plaintiffs blamed on poor device design.

While the company refutes wrongdoing, it stopped selling the implants in August 2013, following an FDA announcement saying it would step up its review process for new versions of the product. J&J will appeal the verdict.

Kyocera Medical Gets FDA Clearance for Initia Hip System

Japan-based Kyocera Medical Corporation has gained FDA marketing clearance for its Initia total hip system.

The Initia system includes zirconia-coated alumina ceramic femoral heads.

It is also available with cobalt chrome femoral heads, giving surgeons the option of ceramic or metal heads. The Initia system includes 16 tapered-wedge stem sizes.

EU Device Trade Groups Merge Into One Unit

The European Diagnostic Manufacturers Association and the European Medical Device Manufacturers Association have formally consolidated into a single body called MedTech Europe.

At the helm, Serge Bernasconi and the association retains the ability to help in-vitro diagnostics and medical devices manufacturers of all sizes operating in Europe with their respective concerns.

Voluntis Scores FDA Clearance and CE Mark for Insulia

Voluntis has received FDA marketing clearance and the CE Mark for Insulia.

The application software gives patients insulin dose recommendations and coaching messages in response to blood glucose values and other diabetes-related data.

A clinician programs the range in which patients need to be. The dose adjustment calculations are synced into the application and are accessible to the patient via a web portal or by smartphones and tablets.

Insulia will be available in the first half of 2017.