Tag Archives: Device Approvals

Recent Device Approvals: LifeVest Wearable Cardioverter Defibrillator

Recent Device Approvals: LifeVest Wearable Cardioverter Defibrillator

The FDA has recently approved the LifeVest Wearable Cardioverter Defibrillator to be marketed. The Zoll LifeVest is a wearable cardioverter defibrillator to monitor and treat dangerous, abnormally fast heart rhythms. These abnormal rhythms can lead to a complete absence of heartbeat (sudden cardiac arrest) and death (sudden cardiac death) if they are not treated. This device was first approved for patients 18 years of age and over in 2001, and it is now available for children.

The LifeVest is worn outside the body day and night. It treats abnormal rhythms by applying a high energy shock similar to that of a traditional defibrillator.

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Medical Device Single Audit Program (MDSAP) Mid-Pilot Status

The FDA just released the Mid-Pilot Report for the Medical Device Single Audit Program (MDSAP), to provide the current status of the program’s performance goal and objectives.

The goal of the MDSAP pilot is to provide objective evidence that a regulatory audit of a medical device manufacturer conducted by an MDSAP-recognized auditing organization can fulfill the needs of participating regulatory authorities.  The MDSAP pilot’s objectives include developing the infrastructure, processes, training, and stakeholder commitment necessary to launch the operational phase of the MDSAP in January 2017.

The participating regulatory authorities are the Therapeutic Goods Administration of Australia, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, Japan’s Ministry of Health, Labour and Welfare, with the Japanese Pharmaceuticals and Medical Devices Agency, and the United States Food and Drug Administration.  The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are official observers.

In a related matter, the new version of ISO 13485 Quality Management System standard, an important element on which the MDSAP Pilot is based, will publish in the coming months.  Two years after the ISO 13485 standard is published, third party auditing organizations or “registrars” may issue industry certifications only to the new version of the standard.

The FDA encourages manufacturers to participate in the MDSAP Pilot prior to the implementation of this key transition initiative, and before the program becomes mandatory in certain regulatory jurisdictions.

For more information about the MDSAP and the participating regulatory authorities, see the FDA’s MDSAP webpage.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health

CDRH Industry: Medical Device Export Certificates: Revised FDA Fees

CDRH Industry: Medical Device Export Certificates: Revised FDA Fees

Today the FDA issued a Federal Register (FR) Notice announcing revised fees for medical device export certificates that will go into effect on September 1, 2015. This is the first time the FDA has changed the fees for these certificates since the start of the export certification program in 1996.

Since February 2003, the FDA’s costs to process medical device export certificates have increased. Because of this, the agency is revising the formula used to calculate the number of original and subsequent device export certificates issued and raising the fee for subsequent certificates. These changes are necessary to ensure that the program remains self-sustaining.

More information about exporting medical devices and the fees for export certificates for all FDA-regulated products are available on the FDA’s website.

Source: FDA.Gov

Recent Device Approvals: Restylane Lyft with Lidocaine Injectable Gel Injectable Dermal Filler

The FDA has recently approved the Restylane Lyft with Lidocaine Injectable Gel Injectable Dermal Filler to be marketed. Restylane Lyft with Lidocaine is a hyaluronic acid gel that is injected into moderate to severe facial folds and wrinkles. It may also be injected into the check to temporarily correct age-related volume loss in patients over the age of 21. This product also contains a small amount of a local anesthetic (lidocaine) to help to reduce the pain of the injection.

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary, If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision.

Recent Device Approvals: ORBERA™ Intragastric Balloon System

The FDA has recently approved the ORBERA™ Intragastric Balloon System to be marketed. The ORBERA Intragastric Balloon System is a weight-loss system that uses a gastric balloon that occupies space in the stomach. The balloon is placed into the stomach through the mouth, using a minimally invasive endoscopic procedure, while the patient is under mild sedation. Once in place, the balloon is filled with salt water (saline) so that it expands into a spherical shape. The balloon can be filled with different amounts of saline (from 400 to 700 cc) to best match the patient’s body structure.

For more information: FDA

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary, If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision

Device Approvals: Edwards SAPIEN 3 Transcatheter Heart Valve

Device Approvals: Edwards SAPIEN 3 Transcatheter Heart Valve

The FDA has recently approved the Edwards SAPIEN 3 Transcatheter Heart Valve to be marketed.  The Edwards SAPIEN 3 Transcatheter Heart Valve (often referred to as SAPIEN 3 THV) consists of a catheter-based artificial aortic heart valve and accessories used to implant the valve without open-heart surgery. The valve is made of cow tissue attached to a balloon-expandable, cobalt-chromium frame for support. The SAPIEN 3 THV is the third generation of the SAPIEN THV that FDA originally approved in 2011. The device has a major design change that adds a skirt at the base of the valve frame to minimize leakage around the valve.

Disclaimer: The EDC Developer blog is “one man’s opinion”. Anything that is said on the report is either opinion, criticism, information or commentary. If making any type of investment or legal decision it would be wise to contact or consult a professional before making that decision