How the U.S. FDA Approval Process Works

by Arianna Lane marketing head

FDA Approval depends on the type of product you are planning to market in the United States. FDA does not insist to complete approval for all types of products. The approvals are limited to certain scope of products. The USFDA's regulatory approaches to marketing approval of drugs, cosmetics, food, medical devices are of different procedure. These differences are dictated by the laws that FDA enforces and the relative risks that the products pose to the general public.

a. Approval of Food and Dietary Supplements

FDA does not approve any of the food items such as beverages, nutraceuticals, dietary supplements, meat and or poultry. Food establishments do not have to obtain any type of FDA Certification before marketing their products in the United States.

However, Food Facilities are required to register with the FDA and comply with Labelling requirements. Registration and Label compliance does not mean it is FDA approved. If a manufacturer wishes to market new food additive, then it is required to go for FDA approval by submitting appropriate test reports and prove to FDA that the additives are safe for human.

Approval of Drug Products

FDA has pre-arranged safe and effective drug list called Over the Counter (OTC) drugs. This is listed in the official monograph. If the drug is in the final OTC monograph, the manufacturer can market without FDA approval.

US FDA Approval is a MUST for any new drug which does not match with the monograph. OTC Drug manufacturers must register the establishments with FDA and list their products.

c. Approval of Medical Devices

As per US FDA regulation, medical devices are divided into three risk-based categories known as Class I, Class II, and Class III. Few of the Class II and most of the Class III medical devices require approval before registration and listing. Class I medical devices on the other hand which may cause low risk of harm to the patient, are subjected to general controls only, and most are exempt from premarket notification requirements.

Medical Device manufacturers must register their establishments with FDA and complete the listing. Registration or Listing DO NOT indicate approval.

d. Approval of Cosmetics

USFDA do not make mandatory cosmetic product approval before marketing. Cosmetic companies are required to register as per Voluntary Cosmetic FDA Registration program.

Cosmetic products and ingredients, and their labelling, do not require FDA authorization before they go on the market. There’s one exception: color additives (other than coal-tar hair dyes). However, Cosmetics must be safe for their intended use and must be properly labelled.

A Cosmetic product can be considered as Drug, if the claims in cosmetic label does not correct or have any medicinal claims. In this case, ingredients not listed in the monograph require approval.