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The FDA’s process for bringing devices to market starts with a device’s risk classification and moves next to the level of controls placed on the device — not only for approval purposes but also for manufacturing, labeling, packaging and other activities that are monitored throughout a product’s lifecycle for enforcement purposes.
Medtronic is relaunching its Harmony Transcatheter Pulmonary Valve (TPV) system after a March 2022 recall following six reports of a failure of the capsule at the end of the delivery catheter.
At the end of the surgery, the surgeon removes the device with the needles stored safely inside, eliminating the potential for needle loss inside the patient.
Achieving marketing authorization under FDA rules includes submitting your device under the correct classification — and companies can struggle to determine which class a new medical device falls into.