The Food and Drug Administration’s regulatory approaches to marketing approval of the products it regulates are as varied as the products themselves. These differences are dictated by the laws FDA enforces and the relative risks that the products pose to consumers.
Some products — such as new drugs and complex medical devices — must be proven safe and effective before companies can put them on the market. The agency also must approve new food additives before they can be used in foods. Other products — such as x-ray machines and microwave ovens — must measure up to performance standards. And some products — such as cosmetics and dietary supplements — can generally be marketed with no prior approval.
At the heart of all FDA’s medical product evaluation decisions is a judgment about whether a new product’s benefits to users will outweigh its risks. No regulated product is totally risk-free, so these judgments are important. FDA will allow a product to present more of a risk when its potential benefit is great — especially for products used to treat serious, life-threatening conditions.
FDA reviews the results of laboratory, animal and human clinical testing done by companies to determine if the product they want to put on the market is safe and effective. FDA does not develop or test products itself. The Agency does this pre-market review for new human drugs and biologics (such as vaccines, blood products, biotechnology products and gene therapy), complex medical devices, food and color additives, infant formulas, and animal drugs.
FDA has streamlined its review process for medical products in recent years to help speed important new treatments to patients. For example, the average review time for an innovative new drug is now only 6 months, and some have been approved even faster.