FDA- All You Need To Know - All In One Blog

May be you have seen word FDA approved on so many company’s website promoting a medical product or medicine. Some manufacturers and marketers say that their products are approved by the FDA. So what does it mean and why it is given? These are some of the questions that might be surely arising in your mind. If it is so then read on this article as it will discuss about FDA approval, why these are given, regulations, training and lots more.

What is FDA?

F.D.A an abbreviation of Food and Drug Administration is the federal agency responsible for protecting the health of public. It has the regulatory authority of analyzing the safety of medical devices, human drugs, foods, animal medication, biologics, animal feed, cosmetics and other health-related products. Many of the products undergo pre-market approval (review of effectiveness and safe to use feature by the experts prior to marketing). The agency does not approve laboratories, health care facilities, manufacturers, or producers but they scrutinize the product manufacturers to examine that they fulfill the entire essential and practices for manufacturing.

F.D.A. has developed so many new methods to ensure the effectiveness of medical products and avoid the situation of people being harmed or injured due to negative complications of any drug.

Approvals of FDA

FDA review and approval is needed before marketing any medical product. FDA approvals of Orphan Drugs and Rare Diseases is necessary to advance the development of any medical product that promises the treatment of rare diseases or fatal conditions. The scientific and clinical data submissions are evaluated from the sponsors to designate the specific product as promising for the rare diseases. Various programs are administered by OOPD (Office of Orphan Products Development) that tests the efficacy of medical device, drugs, and medical foods in rare conditions. There are numbers of leading companies providing training on how to prepare and/or review the Orphan Drug Applications in optimal way without wasting much time.

To acquire the clearance from this federal agency, it requires preparing and submitting the different applications showing that specific medical product is legally marketed for the intended use as promise. Before companies market any drug and biologics, it must be proven safe for the satisfaction of FDA. The agency does not develop product but the experts review the results of animal, human, and laboratory clinical testing done by the manufacturers of that product. Once the product clears the FDA Audits and Inspection of Clinical Investigators that means the FDA has determined that product benefits and effectiveness has outweigh the potential risks for the same use.

The agency classifies the devices according to the risks. The highest risk devices such as implantable infusion pumps and mechanical heart valves require getting the FDA approval before marketing. To fulfill this task, the product or drug manufacturer must prove that the specific device gives a sound assurance of effectiveness and safety for the intended use. Low-risk medical devices such as some bandages are exempted by the agency from the premarket review when they are manufactured using same technology for the same use. FDA has cleared moderate-risk devices on the basis of FDA determination which shows that these are equivalent to existing legally marketed device of similar type.