What is US FDA Certificate?
US FDA certificate is a document which is used to verify such registration and its validity by a third-party organization. As such FDA dose not issue any certificate except to Domestic Firms in USA.
Most of us are aware of the US FDA, but do you know that it is the most important regulatory body to maintain the safety of different healthcare products, including surgical devices?
The role of the US FDA is to review the new medical devices prior to entering them into the market.
There are several certificate types approved by the U.S. Food and Drug Administration that are required for importation, delivery or marketing of medical devices in United States. Understanding these different certificates will help you to take better decisions for your business.
US Food and Drug Administration is a federal agency responsible for the protecting and promoting public health by regulating food, medical device, tobacco products, drugs, veterinary products etc.
Most of the product regulated by FDA have a mandatory registration requirement before they are allowed for sale or export to USA, whereas some of the products are also approved by FDA before being placed on the market and such approval is given by FDA after reviewing the safety, quality and efficacy of the product.
Manufacturer Exporters and Traders are often asked by their customers whether they are FDA Registered?
- US FDA Certificate for Export Purpose is a document providing information related to a DRUG or Establishment regulatory/marketing status as available with the FDA.
- FDA Certification is often asked by foreign customers or foreign government to seek assurance that product exported from USA can be marketed in US or they are required as a part of their registration procedure.
Know More About US FDA Certificate and Benefits?
Benefits of US FDA Certificate
A US FDA certificate will help any business that wants to sell an FDA certified product or service. With the increase in drugs and medical devices coming out into the market, this is very important. FDA certificate is issued by FDA through its center to provide a guarantee that those products are safe, reliable, effective and fit for the purpose of use. And it’s a way for the government of US to control all FDA-regulated medical device companies in America.
A US FDA Certificate is significant for businesses and medical professionals that are responsible for handling food products for human consumption. The certificate will help ensure that your products meet the standards of all regulatory bodies in the US.
What is US FDA Approved ?
Many people use the word “FDA Approved” on their websites, products or commercial promotion but such statement is not correct as Pre-Market Approval is not a mandatory requirement for all the products. US FDA dose not promote or accept such statements.
Which Products Require FDA Approval ?
To understand this requirement, you will need to classify your product in one of the below category’s
1) FOOD, Beverages, Dietary Supplements – NO FDA Approval required
2) Medical Device –
a. Class III – FDA approval required
b. Class I & II- Some of them might require PMA
3) Drugs
a. OTC Drug confirming to Monograph – NO FDA Approval required
b. Compounded Drugs – NO FDA Approval required
c. New Drugs, Biologics – Yes FDA Approval Required
4) Cosmetics – NO FDA Approval required
5) Color Additives- Yes FDA Approval is required for colors additives used in food, drug, cosmetics and some medical devices. Some of the colors also required FDA Batch Certification.
Can we Claim FDA Certified Plant ?
No FDA dose not Provide any such certificate, so it is not correct to claim FDA Certified Plant.
FDA has the authority to inspects facilities for current Good Manufacturing Practices (cGMP) and based on such inspections FDA issues FORM 483 observation and Establishment Inspection Report (EIR) which states whether any action is required to be taken or not.
How to get FDA Certificate ?
We as US Agent will issue certificate after establishment registration (Food, Drug, Medical Device) with FDA is completed using our services. US FDA will not issue any certification and third-party certificates have no legal validity and US FDA dose not recognizes such registration certificate.
What is the Validity of US FDA Certificate ?
Third Party Certificates issued by US Agents are normally valid for 1 year from date of issuance.
What are the Fees for US Agent Services ?
We have one of the lowest fees for US Agent services, Talk to us now for more details.
Do we charge additional for US FDA Certificate ?
We provide FDA certificate as part of our US Agent services, and we don’t have any additional fees for US FDA certificate.
How to Get Export FDA Certificate ?
US FDA provides domestic manufacturer with Export Certificate such as
- Certificate of Free Sale
- Certificate of Pharmaceutical Products
- Certificate for Cosmetic
- Non-Clinical Research Use Only Certificate
- Certificate to Foreign Government
USE of FDA Logo on Label ?
FDA logo should not be used on labels as it may imply a false endorsement. FDA logo is for official government use only.