FDA Certification
What is FDA Certification?
FDA Certification provides external validation that an organization is capable of consistently producing a product or service that adheres to the United States Food and Drug Administration (US FDA) standards. FDA standards are crafted for pharmaceuticals, food, beverages, medical devices, and radiation-emitting devices.
Integrated Assessment Services (IAS) can help your company obtain FDA certification. We assist manufacturers in obtaining FDA registration with a valid registration number. IAS also assists food, pharmaceuticals, and medical device manufacturers in registering with the US Food and Drug Administration. We provide high-quality services at a cost that is both competitive and reasonable. With the help of IAS, you can become compliant with the FDA. IAS provides a very simple yet efficient certification process to help your organization achieve FDA Certification in a timely manner!
Who can Apply for FDA Certification?
FDA registration is available to food facilities, pharmaceutical companies, dietary supplement producers, and medical device manufacturers. Manufacturers who want to sell medical equipment and medications in the United States must first register with the FDA. Cosmetics firms can also register with the FDA; however, it is not compulsory.
In the United States, registration is critical for selling your goods. Although FDA certification is not necessary for food items, it is required of food production businesses. In addition, new drug and nutritional supplement products require FDA approval. The Food and Drug Administration (FDA) examines the following factors in order to approve a product:
- Site inspections, process inspection, and implementation of the necessary processes.
- Clinical trials, test results, and research papers and protocols for further study.
What is the Difference Between FDA Registration and FDA Certification?
The FDA has different requirements for registration and certification. FDA registration is a requirement for FDA-regulated products, such as dietary supplements and medical devices. FDA certification is not compulsory, but FDA approval of nutritional claims on the label (e.g., “gluten-free,” “fat-free,” or “natural”) requires FDA certification. FDA Registration and FDA Certification are both processes through which a business’s products become FDA compliant.
You must obtain FDA registration before you apply for FDA certification for your business. FDA registration certifies that your facility is in compliance with FDA standards and regulations. It ensures that your products are safe for distribution within the country. This process is required for FDA certification, regardless of the number of products manufactured.
FDA Certification for Medical Devices
The FDA has a special process called FDA certification for medical devices. This is to ensure all medical devices that are supplied to the United States are safe and effective. FDA certification for medical devices is mandatory for medical device manufacturers that want to sell their products in the United States. The FDA has a stringent set of guidelines that medical device manufacturers must meet before their product can be FDA certified.
Obtaining FDA Certification for Medical Devices
The FDA has created a rigorous certification process in order to ensure that medical devices distributed within the United States meet specific safety and efficacy standards.
In order to obtain FDA certification for medical devices, manufacturers must complete an FDA application, which is available on the FDA website. The application requires extensive information about the device, including the following:
- FDA 510(k) clearance
- FDA Investigational Device Exemption (IDE)
- FDA-approved labeling
- Clinical data to support the device’s safety and efficacy
- FDA-required Quality System requirements
- FDA audit reports if available
- FDA proof of inspection for the manufacturing facility
IAS can help your company achieve gather all of the required documentation to receive FDA certification for medical devices. Once you successfully achieve FDA Certification through IAS, you can check the status of your certificate by visiting our FDA Certificate Search Page!
How to Get FDA Certification?
One of the key criteria for manufacturers to market their products in the United States is to get an FDA registration number. The FDA registration number is not required for pharmaceuticals and medical devices, despite the fact that FDA certification is required. It’s a one-of-a-kind registration number that shows the establishment is registered with the US Food and Drug Administration. It does not imply that the establishment or product has received FDA approval.
The FDA registration certificate is not issued by the FDA. IAS will assist you in obtaining FDA approval for your business. We issue a registration certificate that states:
- The registration procedure has been completed successfully.
- FDA registration for your business.
- Your registration number is also valid.
FDA Certification Cost
The FDA certification cost covers the time and effort put into becoming FDA certified, as well as the resources used. FDA-approved manufacturers are charged an FDA fee of $400 for registration or $2,975 for FDA pre-approval. Likewise, if your organization hires an FDA consultancy to assist you with meeting FDA certification requirements, the FDA certification cost is often between $500 and $1,000. The FDA certification cost may vary according to the number of products manufactured by your company and the size of your business. Additionally, the FDA certification cost covers certification for one whole year. The FDA certificate must be renewed each year to continue doing business in the United States.
How to Get FDA Certified Through IAS ?
- Decide whether you want to get FDA certification for distinct items or the same product with a range of certifications.
- To discuss the details on how to get FDA certified, please contact us with the completed Application form.
- Manufacturer/trader submits initial documentation (based on the FDA certification standard, including test certificates).
- Verify that all documentation satisfies legal requirements.
- To confirm that the product satisfies the standards, conduct an audit.
- Submission of final documents, as well as any additional clarifications that may be required.
- Evaluation and approval of the final document.
- FDA certification will be issued after your organization successfully completed the audit.
Click here to learn more about our FDA Certification procedure! Also, see the FDA Certification frequently asked questions for additional information on FDA certification.
For more information on how to get FDA certification, please contact us today!