Welcome to our blog post where we have gathered everything you need to know about FDA Registration. In this article, we have discussed many different topics related to FDA Certificate, FDA approval and FDA. We wish you a good reading.
What does FDA stand for?
FDA stands for Food and Drug Administration. In Turkish, it is known as the "Food and Drug Administration". It oversees the safety of food, drugs, medical devices, cosmetics, supplements, veterinary products, tobacco and certain electronic devices in the US.
What is FDA certification?
FDA certification refers to the registration, notification and approval processes required for products to enter the US market. Depending on the product, it may be facility registration, product list, approval letters or certificates.
What is FDA approval?
FDA approval is the official authorization to market a product in the US.
- Those requiring approval: Medicines, biological products (vaccines, blood products), medium-high risk medical devices, food additives, color additives.
- Those for which registration is sufficient: Foods, food supplements, cosmetics (except color additives).
What is FDA certification?
- FDA Registration certificate: Documents such as food facility registration, device establishment registration, cosmetic facility notification.
- Letter of approval: The official letter (NDA, BLA, PMA, etc.) indicating that the FDA has authorized the marketing of a particular product.
How to get FDA certification?
1. Determine the product category (food, pharmaceutical, device, cosmetic, etc.)
2. Appoint an FDA authorized representative (U.S. Agent) in the U.S.
3. Perform facility registration and product listing.
4. Apply for approval with clinical/test files if necessary.
5. Obtain registration or approval after FDA review.
How to get FDA approval?
- Medicines Clinical trials → NDA/ANDA → facility review → approval.
- Devices Class designation → 510(k)/De Novo/PMA application → audit → authorization.
- Food additives: Premarket approval or GRAS notification.
- Color additives: Permitted according to approved list + lot certification for some.
- Packaging/adhesive: Food Contact Notification (FCN).
What is the FDA in medicine?
In medicine, the FDA evaluates the safety and effectiveness of new drugs, vaccines and medical devices. Clinical trials are conducted under FDA registration supervision.
Which products are FDA approved?
Approved ones:
- Prescription and some OTC medicines
- Biological products (vaccines, monoclonal antibodies, blood products)
- Medium-high risk medical devices (implants, stents, pacemakers)
- Food additives (e.g. sweeteners)
- Color additives (used in cosmetics and foods)
- Baby food (with prior notification)
- Certain tobacco products (with PMTA/SE authorization)
Those who are registered:
- Foods
- Food supplements
- Cosmetics (except color additives)
- Packaging and adhesive products (with FCN)
Are there any FDA approved cosmetic products?
Cosmetics are not individually approved by the FDA. However
- Facility and product notification must be made.
- The color additives used must be approved by the FDA.
- If there are therapeutic claims, the product is considered a "medicine" and requires approval.
What is the FDA form?
Official application files used according to product type.
- Medicine IND, NDA, ANDA, BLA
- Device: 510(k), De Novo, PMA
- Food: Facility Registration, Prior Notice
- Packaging: Food Contact Notification (FCN)
How to make an FDA Registration inquiry?
The FDA's official databases are used to check registration and approval status:
- Drugs Drugs@FDA or NDC Directory
- Medical Devices: 510(k) Database, PMA Database , Registration & Listing
- Color additives:Color Additives Status List
- Food facility registration: Not publicly available, documentation must be requested from the producer.
Is a food registration certificate the same as an FDA certificate?
No, no, no.
- Food registration certificate: A certificate issued by the Ministry of Agriculture and Forestry in Turkey, valid in the domestic market.
- FDA certification: The registration/approval process required to sell in the US.
What documents are required for a food registration certificate?
- Trade Registry Gazette
- Certificate of activity and signature circular
- Lease contract/registration and business license
- Food engineer/specialist contract (if required)
- Layout plan and hygiene certificates
