When deciding to approve a product or drug, the FDA has to decide if the benefits outweigh the risks. The FDA is usually inclined to approve a product that has a higher risk if the potential benefit is significant -- like an artificial heart valve that can save someone's life. FDA approval is usually mandatory to market or sell products in the US that might have a significant risk of injury or illness, but can also benefit your health -- such as prescription medications, over-the-counter medications, vaccines and Class III medical devices.
Complex medical devices that are implanted in your body, life-sustaining, or have the potential to cause significant injury or illness in the body are in Class III. Those include implanted pacemakers, replacement heart valves and even breast implants. Lower-risk devices and products used outside of the body, like condoms, motorized wheelchairs and catheters, fall into Class II and Class I. Class II and Class I medical devices are usually "cleared" by the FDA, which means the manufacturer can demonstrate that their product is " substantially equivalent to another similar legally marketed device" that already has FDA clearance or approval.
Those already-cleared products are called a predicate. For instance, let's say hypothetically Apple wanted to create a blood pressure monitor, using the same design and features of one that already exists. The company could get FDA clearance if it can compare its product to another that's already on the market and demonstrate that it is it just as safe and effective, and works in the same way.
Companies must submit a "premarket notification submission" or k to the FDA so that it can review the product and clear it. Once the FDA declares that a new medical device is substantially equivalent to a predicate, it is "cleared," and can be marketed and sold in the US. The problem with the FDA's approval system, as John Oliver pointed out, is that often companies get their product cleared by using older predicates that were later recalled for safety reasons.
Approval Not every vaccine is granted an emergency use authorization before full approval. FDA and the Vaccine Review Process For over a century, FDA-authorized and approved vaccines have prevented potentially serious diseases such as measles, influenza and whooping cough. Vaccinations have helped reduce and prevent deadly outbreaks of smallpox and polio. The approval system for vaccines uses scientific data and exacting standards to ensure safe and effective vaccines.
These review process includes: Clinical trials. The FDA requires rigorous testing of vaccines through a series of clinical trials to make sure they work and are safe before authorizing or approving them for the public. The laboratories that conduct the trials are independent from the vaccine companies and the government, so the information they convey to the FDA for its approval process is not biased.
Risks and benefits. FDA approval of a vaccine involves careful assessment of risks and benefits. Before approval can happen, the clinical trials and other data used by the agency must demonstrate that the benefits of a vaccine are greater than its risks for those who will be vaccinated. How can you tell if your product needs pre-approval from the FDA before you can market it to the public? NB: These lists are not fully inclusive but will give you a general overview of which products needs FDA pre-approval prior to marketing to the public.
The FDA has regulatory authority in the event of a public safety issue related to your product. Post Views: 5, FDA Audit.
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