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Home » Topics » Medical Devices » Quality

Quality
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Firm Hit With 10 Observations Over Alleged Reporting Issues

May 9, 2016
The FDA is accusing a medical devicemaker of neglecting to report five cases of radiation leakage from its products and other reporting violations, according to a 10-observation Form 483. Read More

FDA Extends Comment Period for Refurbishing Medical Devices

May 9, 2016
The FDA is extending a comment period to June 3 for its proposal to redefine third-party servicing for medical devices. Read More

Stakeholders to FDA: Get Tougher on Cybersecurity

May 9, 2016
Stakeholders are encouraging the FDA to beef up its stance on cybersecurity, making suggestions provided in draft guidance mandatory rather than voluntary. Read More

After Nearly A Two Decade Wait, Health Canada Finalizes IVD Regs

May 9, 2016
Health Canada has finalized its regulations on in vitro diagnostic labeling 18 years after issuing draft guidance. Read More

LDT Developers: Get Cracking on Quality System, Design Controls

May 9, 2016
Companies that develop laboratory-developed tests should begin to incorporate design controls and establish a quality system ahead of the expected finalization of FDA guidance this year, experts advise. Read More

FDA Takes Action on Electrical Stimulation Devices

May 9, 2016
The FDA is looking to ban electrical stimulation devices used to prevent self-injury and aggressive behavior. Read More
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Medtronic Recalls Battery Pack

April 20, 2016
Among the seven reports, one included a fire. Read More
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Intuitive Surgical Releases Safety Notice on Use of da Vinci Instruments

April 18, 2016
The notice was issued due to the potential risk of the presence of particulate. Read More

Focus Diagnostics Recalls Lab Kits Due to Invalid Results

April 15, 2016
The recall involves units manufactured between July 30, 2015 and Feb. 11. Read More

Vascular Solutions Recalls Guardian II Hemostasis Valves

April 12, 2016
The company initiated the recall March 3. Read More
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Boston Scientific Recalls All Fetch 2 Aspiration Catheters

April 12, 2016
The recall involves 21,155 devices. Read More

FDA Revokes MQSA Certificate From Huntington Radiology

April 12, 2016
In a rare move, the FDA has revoked the mammography quality standards act certificate from a California radiology facility. Read More
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