The Food and Drug Administration (FDA) is the U.S. Federal Food and Drug Administration, which is responsible for regulating and approving the sale and use of food, drugs, cosmetics and medical devices. If a company wants to sell these products in the U.S. market, it needs to be FDA certified, so for the cost of FDA certification, the cost of applying for FDA certification for different types of products is different, today, let's take a look at it
Food FDA Certification Cost:
Food manufacturers are required to register their food, apply for an FDA Food Facility Registration Number, and renew it annually. The registration fee varies depending on the size of the business and the type of product, but usually ranges from $300 to $1000.
For some food products, additional certifications for food additives, colorings, health products, etc., may be required, and the associated costs will vary.
Drug certification fees.
New Drug Approval Fees: Depending on the different types of new drugs, FDA approval fees can run into the millions of dollars. The cost of drug registration usually also requires hundreds of thousands.
Cosmetic certification fees.
Cosmetics registration fee: In order to sell cosmetics in the United States, companies need to go through FDA certification for cosmetics and pay a fee of $500-1,000, depending on the category of cosmetics.
Medical Device Certification Fees.
Medical Device Registration Fees: Depending on the type, risk level, and complexity of the medical device, FDA certification fees can be more than $5,000 or even higher. For example, for high-risk medical devices, PMA approval is required, and the cost is as high as hundreds of thousands of US dollars.
Therefore, if an enterprise is required to consult a professional consultant or lawyer before FDA certification, it is best to understand the entire certification process and determine the corresponding fee according to the product category. And ensure that the products comply with the relevant FDA regulations and standards to avoid delays in certification and additional costs.