Tag: FDA compliance

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FDA Issues Warning Letters to Endoscope Manufacturer Olympus

The U.S. FDA’s Center for Devices and Radiological Health has issued two warning letters to endoscope manufacturer Olympus Medical Systems Corp., following facility inspections.

FDA Warns Two Massachusetts Infusion Pump Makers Owned by Same CEO
MITA Calls for Stabilizing MDUFA Program in Letter to FDA
3D Systems, VHA to Collaborate on Additively Manufactured Medical Devices
FDA Pushes Back AED Accessory Compliance Date
Streamlining FDA Compliance with Digital Adverse Event Submissions

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All

FDA Issues Warning Letters to Endoscope Manufacturer Olympus

The U.S. FDA’s Center for Devices and Radiological Health has issued two warning letters to endoscope manufacturer Olympus Medical Systems Corp., following facility inspections.

FDA Warns Two Massachusetts Infusion Pump Makers Owned by Same CEO
MITA Calls for Stabilizing MDUFA Program in Letter to FDA
3D Systems, VHA to Collaborate on Additively Manufactured Medical Devices
FDA Pushes Back AED Accessory Compliance Date
Streamlining FDA Compliance with Digital Adverse Event Submissions