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What Medical Devices Require FDA Approval?

The FDA is the Food and Drug Administration which oversees various directorates in the Department of Health and Human Services. These areas include medical products, foods, veterinary medicine, tobacco and other relevant policies and operations.

What Medical Devices Require FDA Approval

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The responsibility of the FDA

The FDA is responsible for protecting the public from harmful devices and drugs etc. It does this by evaluating and assuring the effectiveness and safety of such things as medical devices, vaccines, veterinary drugs, cosmetics, food supplies, dietary supplements and other biological products.

What is the 510(k) Submission Process?

The FDA 510k clearance process is regarded as a premarket submission of a device to ensure its safety and effectiveness to the FDA. The FDA receives thousands upon thousands of applications each year and because of the sheer amount of submissions, receiving a finalised decision can take months.

Thankfully, the FDA created the Accredited Persons Program to help complete the heavy workload. This process involves submitting your 510(k) to a third party review program such as http://www.fdathirdpartyreview.com. Once submitted, the said company will review your application and assess it according to FDA standards. Following the initial completion of the reviewing process, the Accredited person the forwards the findings to the FDA. The FDA then have 30 days to review and finalise your application, resulting in a much faster reviewing process from time of submission to completion.

Medical Devices and FDA Approval

Certain medical devices require FDA approval before they receive the green light for marketing and manufacturing. The said medical device, according to the FDA, can be any of the following:

  • Instrument
  • Apparatus
  • Implement
  • Machine
  • Contrivance
  • Implant

The main factor that each of these medical devices have in common is the fact that they are intended for humans or animals to use. For example, they may be intended to diagnose a disease, or even cure it. They may also be required to prevent a disease, mitigate disease or intended for medical treatment etc.

In order for one of these medical devices to be deemed fit enough for human or animal use or exposure etc., they must be FDA approved. The process may be time consuming, but that is why most people choose to go through an accredited person rather than sending their submission directly to the FDA. Due to long response times, it is advised to seek assistance from a third party review program instead.

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