510K: How to evaluate the quality of the Medical devices?

By Kelly Shelton   05/07/2020

  Category: Other Blogs

The Guide for the clinical evaluation of medical devices is a useful tool for carrying out evaluations of methodological quality health technologies adapted to the characteristics of medical devices. In this way, the health professional will be able to correctly carry out an evaluation of the medical devices available in the market, complying with the requirements of the regulatory framework established by the authorities of our country in the field of health.

How it is defined?

According to the WHO, health technology assessment is systematic process. It is a complete valuation of impacts of health technology, properties and effects. It must take into account the medical, social, ethical and economic dimensions. And its main objective is to provide information to be applied to decision-making in the health field. You can get online help for medical device expert consulting, now.

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The techniques and methods used in each of the evaluations depend to a large extent on the questions that the research intends to answer, the type of technology involved and the time available to send an answer. Regarding this time, it is preferred to provide a timely response that allows applicants to make decisions at the appropriate times. The answer to this type of medical device expert consulting is materialized in complete reports, rapid evaluations and summaries of ETES, which are intended to be useful sources of information in decision-making.

What is 510 (k)?

The 510 (k), or premarket notification, is the procedure that the FDA mostly requests from manufacturers of medical devices for marketing in the US market. The 510 (k) is different from the PMA process (pre-market approval). And through the identification of the most appropriate product code for the medical device that is to be sold in the US, it is possible to establish if the US regulation requires a 510 (k) or a PMA. To ensure the medical device is trusted, a 510k (approved by FDA) seal is given, which means the medical device can be marketed safely. It is why, 510k medical device is an ideal choice for any clinical research or drug production.

The 510 (k) procedure is based on the demonstration of substantial equivalence between the medical device subject to FDA approval and at least one medical device with the same intended use and similar technical characteristics (predicate device) already present in the American market. Demonstrating substantial equivalence means demonstrating to the FDA that the 510k medical device to be registered is as safe and effective as the predicated device.

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