06 Sep

The FDA (Food and Drug Administration) published guidelines in three subjects earlier this year regarding evolving medical technology. These rules are not meant to control businesses and their new inventions, nor are they created to jeopardise development in the health industry.

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The 21st Century Cures Act has been designed to move this speedily forward in a way that joins together both houses of Congress before the current term concludes.

General wellness products:

The guidance informally regulates welfare products, such as computer software and video games, that can be found in retail stores. The FDA does not consider these items medical machines and will not seek to control them on the basis that they meet two criteria: they do not present a high risk to the consumer and are solely used for everyday health.

Real world evidence (RWE)

This is about data secured beyond the typical medical research route. Whilst this method is unlikely to be employed to secure agreement from the authority to use such a device, RWE supports the utilisation of the scheme beyond its initial objective. Prior to real world application, it is important to understand the data’s origins. This information is collated from the various computer systems used within the delivery of health care, analysis of the medical devices themselves and monitoring the experience of the person receiving medical attention.

Adaptive design

The third policy seeks to tackle the adaptive design of medical studies being used by the FDA to assess whether to sanction the deployment of new medical gadgets. As with all medical trials, some level of change is factored into the design to incorporate changes identified whilst building up the trial’s data without compromising the original purpose, legitimacy and reliability. If not designed properly, this approach can compromise the safety of those within the trial; conversely, when deployed well, it can cut the duration and investment of such medical study.

How long does it take to get an FDA 510k approved? Experts such as FDA third party review help with FDA clearance and have programmes that enables submissions to be brought to market in a much reduced time frame.

Technology and how we use it is constantly evolving and the FDA will continue to have a role well into the 21st century and beyond.

Larry Wilson