Does your product require FDA approval ?
FDA registration does not denote FDA approval.
FDA approval process and FDA certification
Does my product require FDA approval ?
The answer to this question depends on your product category. Here are the FDA approval requirements for each category of products i.e., Food, Drug, Medical Device, and Cosmetics.
What is FDA certification?
There is no such process or definition of “FDA certification” in the United States regulatory framework. Most companies use the term “FDA certification” for FDA-related compliance requirements.
Some of the product categories require prior approval from the FDA. Products such as Food, dietary supplements, and cosmetics do not require prior approval from the FDA.
1. FDA approval for Food
FDA does not approve food products. However, you have to comply with the below-listed general requirements before starting a food business in the USA.
- PFood facility registration
- PLabeling compliance
- PGMP for dietary supplements
- PProcess filing for acidified and low acid food products
- PFSVP (Importer is responsible for Foreign Supplier Verification)
The facility does not require FDA inspection before engaging in food manufacturing. However, the FDA may inspect the food facility at any time.
Food additives require prior approval from the FDA.
You can also visit our FAQ section for Food.
If you need assistance for Food related compliance services, please contact us.
2. FDA approval for Medical Device
FDA approval is not required for most of the Class I devices. Most of the Class II devices require 510 K clearance, and most of the Class III devices require Prior Approval (PMA).
All the medical devices should comply with FDA general requirements such as registration and listing. Also, medical device facilities are required to pay an annual FDA fee.
If you need further assistance for medical device registration and listing, please contact us.
3. FDA approval for Drugs
FDA requirements for drugs are complex. Regulatory requirements for Animal and Human drugs are different. Interestingly, FDA approval is not required OTC monograph products.
Please go through the below link for more information about OTC monograph products.
New human drugs are approved through the NDA (New Drug Application) route, which required extensive clinical and non-clinical information.
Generic drugs are approved through ANDA (Abbreviated New Drug Application). Applicants are not required to provide extensive clinical and non-clinical study information; however, bioequivalence studies may be required.
If you need assistance with FDA approval of drugs, please contact us.