US FDA Approval for Drugs, Food & Medical Devices

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 US FDA's regulatory approaches to marketing approval of drugs, cosmetics, food, medical devices are of different ways. These differences are dictated by the laws FDA enforces and the relative risks that the products pose to the general public.

US FDA Approval of Food and Ayurvedic  / 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 products in the United States.

Food facilities are only required to register with FDA, and comply with Labelling requirements. Registration and Label compliance does not mean its FDA approved.

If a manufacturer wishes to market new food additive, then it’s required to go for FDA approval by submitting appropriate test reports and prove to FDA that the additives is safe for human.

• Food Additives

FDA Approval of Drug Products

FDA has pre-determined safe and effective drug list so called over-the-counter (OTC) drugs. This is listed in 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.

• Drug Establishment Registration
• NDC Labeler Code
• Drug Listing

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 devices require Approval before registration and listing.

Medical Device manufactures must register there establishments with FDA and complete the listing. Registration or Listing DO NOT indicates approval.

• 510k
• Medical Device Establishment Registration and Fees

Approval of Cosmetics

US FDA does not made mandatory cosmetic product approval before marketing. Cosmetic companies are required to register as per Voluntary Cosmetic Registration program.

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

• Cosmetic Label Review

Logo usage and Approval

Many of the manufacturers of Drugs, cosmetics, food supplements, nutraceuticals and medical devices that do not require approval may include the phrase "FDA Approved" on the product's label.

This is NOT correct and FDA may take severe action. If the manufacturer has received a letter from FDA confirming its approval status in case of drugs or medical device it is allowed.

FDA logo should not be used on the primary or secondary information panel. Federal Law prohibits the use or display of FDA logo