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FDA Medical Device, overview of 510(k) guide

Aug 17 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, first, the FDA determines the classification of the medical devices. These medical devices are classified into Class I, II, and III, which determines the regulatory pathway firms need to take to bring their devices into the US market legally.

Most Class I devices are exempt, but some specific devices are required a submission known as the 510(k) which applies to all Class II medical devices.

You must submit a 510(k) within at least 90 days prior to distribution in the United States. Listed below are reasons for a 510(k) submission.

  • 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) submission must demonstrate compatibility or similarity with existing FDA cleared medical devices currently distributed in the United States, which is called Substantially Equivalence (SE). When determining whether or not the subject medical device has SE, the FDA may require 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 examined 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 the subject medical device is equivalent or even superior to comparable and eqivalent devices in terms of safety and efficacy.

FDA may require a 510(k) resubmission, reclassification of your device, or a premarket approval (PMA) application, depending on whether the device can demonstrate Substantial Equivalence .

Our Provision consultants are ready to assist you with FDA regulatory procedures.

We provide consulting services for FDA registration and medical device listing,

certification, label review, and compliance requirements.

If you have questions about FDA regulation of medical devices

or importing of medical devices to the United States,

Office 1-909-493-3276


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