Tag Archives: medical device trials

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

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

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Conducting medical device clinical studies in Europe


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Source:the mergo group