Whenever a new drug or medical device is developed, it must go through a strict set of procedures before it can be used in hospitals and other settings.
In America, this process involves the Food and Drug Administration (FDA), which, along with other roles, is responsible for ensuring drugs and medical devices are both safe and effective.
The FDA also aims to advance the health of the public by helping to introduce innovations in medicine which can improve the lives of thousands of people, making sure they are not only fit for purpose but also that they are generally affordable, so they reach the maximum number of people.
One of the FDA’s major roles is approving medical devices for use, enabling thousands of people to benefit from new inventions and innovations.
According to the FDA, a medical device is defined as an instrument, machine, implant or apparatus which is intended to be used in the diagnosis, cure, treatment, mitigation or prevention of disease in man or animals.
It can also be something which is intended to change or alter the structure or function of a body (human or animal), which does not achieve this through chemical means.
In other words, a medical device can be anything from surgical lasers to wheelchairs, tongue depressors to bedpans, sutures to pacemakers, vascular grafts to intraocular lenses. It covers a huge number of items used in medicine, from the everyday to the lifesaver.
Approval or clearance
Why do I need a FDA 510k clearance? Naturally, each and every new medical device must be thoroughly tested and checked before it is put on the market, to ensure it is safe for use and of genuine benefit to patients
Using a third-party company specialising in the FDA 510k clearance process will ensure medical devices find their way into hospital wards and doctors’ surgeries quicker, helping improve patients’ lives.
The FDA examines every device, either clearing it or approving it. The FDA can clear a device after reviewing a 510k (named after a section of legislation in the Food, Drug and Cosmetic Act). It is also able to approve a device following a PMA (premarket approval) application. Which type of application a device needs in order to be cleared for use depends on its classification..