Sep 08 2022
The US FDA regulates medical devices with strict standards due to the characteristics of medical devices that are applied directly to the human body. Therefore, it is essential to understand the U.S FDA clearance process to enter the U.S market.
To market any medical devices in the U.S, firstly, the FDA determines the class of devices that will be classified. Classes are Class I, Class II, and Class III, which determine each required certification method and approval pathway.
Most Class I devices are exempt, but some specific devices are required 510(k) and also Class II devices.
You must submit a 510(k) within at least 90 days prior to distribution in the United States.
When a related medical device is first distributed in the United States
If the intended use of medical devices already distributed in the United States is changed
When it is necessary to revise the safety and efficacy of medical devices already distributed in the United States
*** Medical devices distributed in the United States before May 28, 1976, are exempt.
Medical devices that require a 510(k) must demonstrate compatibility or similarity with existing medical devices currently distributed in the United States, which is called Substantially Equivalent (SE). When determining whether or not to be SE, FDA may require that the device be tested for performance and efficacy in relation to its technical characteristics and risks.
Performance and Safety Testing
Technical bench testing and biocompatibility will be investigated by FDA, and animal testing and clinical testing may be required if necessary.
When submitting a 510(k), typically no more than 10% of clinical data is required to demonstrate commensurate performance with other devices. Clinical data confirm that it is superior to other devices in terms of safety and efficacy compared to comparable or equivalent devices.
FDA may require to resubmit a 510(k), reclassify your device, or submit a premarket approval (PMA) application, depending on whether the device is SE.
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