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Our dedicated team of regulatory specialists ensures your supply chain stays compliant and efficient. From FDA registration to food safety and import assistance, we help bring your products to market seamlessly.
Stay in control with our intuitive software, designed to track compliance, streamline production, and connect with industry experts—all in one place.
Master FDA compliance with our interactive, self-paced courses. Gain practical, hands-on knowledge to meet regulatory requirements and stay ahead in your industry.
Our Services Include:
✔ FDA Facility Registration – Stay compliant with mandatory registrations
✔ DUNS Number Acquisition – Essential for importers and exporters
✔ GACC & TTB Registrations – Hassle-free approvals for global trade
✔ Label & Ingredient Review – Ensure compliance with FDA standards
✔ Food Safety Training & Software – Empower your team with expert guidance
Our Compliance Services Include:
✔ FDA Registration & Product Listing – Ensure your brand meets MoCRA requirements
✔ U.S. Agent Services – Hassle-free representation for foreign cosmetic brands
✔ Adverse Event Reporting – Stay compliant with mandatory safety reporting
✔ Label & Ingredient Review – Ensure FDA-approved formulations and packaging
Our Expert Services Include:
✔ FDA Establishment Registration & Product Listing – Stay compliant with quick, secure submissions
✔ Label & Ingredient Review – Ensure accurate formulations and FDA-approved labeling
✔ Electronic Submissions via FDA Gateways – Faster approvals with secure digital processing
✔ Compliance Support for U.S. & International Brands – Tailored solutions at affordable rates
Our Medical Device Compliance Services:
✔ FDA Establishment Registration & Device Listing – Hassle-free regulatory compliance
✔ 510(k) Submissions & Master File Support – Get your device FDA-approved faster
✔ Electronic Medical Device Reporting (eMDR) – Ensure safety and compliance effortlessly
✔ Health Canada & EU MDR Support – Expand globally with multi-region compliance
Our Expert Compliance Services:
✔ FDA Facility Registration & Prior Notice Filing – Stay compliant and avoid delays
✔ Label & Ingredient Review – Ensure FDA-approved claims and accurate labeling
✔ Master Manufacturing Records (MMRs) – Maintain precise formulation documentation
✔ Global Compliance Support – Register with international regulatory bodies with ease
Aman Khanna, April 22
"Outstanding customer experience! Their team responds instantly, works efficiently, and provides invaluable tools to simplify exports to the U.S. in full compliance with regulations."
Dream Foods LLC June 17
"Our mission is to deliver top-quality products while meeting all U.S. legal requirements. FDA CertPRO has been a vital partner, offering expert guidance and strong compliance support."
Herbaneutra Private Limited Jan 12
"The FDA CertPRO team provided clear, detailed compliance guidance and necessary regulatory adjustments. They felt like an extension of our own team, making the entire process seamless."
FDA certification refers to the approval or clearance process by which the U.S. Food and Drug Administration (FDA) evaluates products such as food, drugs, medical devices, and cosmetics to ensure they meet safety and efficacy standards. Obtaining FDA certification is crucial for legally marketing these products in the United States.
The process for obtaining FDA approval varies depending on the product type:
Drugs: Submit a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) for generics, providing data from clinical trials demonstrating safety and efficacy.
Medical Devices: Depending on the device classification (Class I, II, or III), you may need to submit a Premarket Notification [510(k)] or a Premarket Approval (PMA) application.
Food and Cosmetics: While these products do not require pre-approval, they must comply with FDA regulations regarding labeling and safety.
It's advisable to consult the FDA's official guidelines or seek assistance from regulatory experts to navigate the specific requirements for your product.
To verify if a product is FDA approved, you can use the FDA's online resources:
Drugs: Search the Drugs@FDA database to find information on approved prescription and over-the-counter drugs.
Medical Devices: Use the Medical Devices Database to check for approved devices.
For other products, such as food and cosmetics, note that the FDA does not provide premarket approvals, but you can check for compliance and enforcement actions on the FDA's website.
The terms "approval" and "clearance" have specific meanings in the context of FDA regulations:
FDA Approval: This applies to drugs and high-risk medical devices (Class III). It indicates that the FDA has reviewed the product's premarket application and determined that it is safe and effective for its intended use.
FDA Clearance: This applies to moderate-risk medical devices (Class II) that are substantially equivalent to an already legally marketed device. The 510(k) process is used for clearance.
Understanding these distinctions is important for determining the regulatory pathway for your product.
No, cosmetics do not require FDA approval before being marketed. However, they must be safe for use and properly labeled according to FDA regulations. The FDA can take action against cosmetics on the market that are found to be unsafe or mislabeled.
Yes, dietary supplements are regulated by the FDA under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Manufacturers are responsible for ensuring that their products are safe and that their labeling is truthful and not misleading. Dietary supplements do not require FDA approval before marketing, but the FDA monitors their safety and can take action against unsafe or misbranded products.
The duration of the FDA approval process varies depending on the product type and the complexity of the application:
Drugs: The review process for a New Drug Application (NDA) typically takes about 10 months under standard review and 6 months under priority review.
Medical Devices: For devices requiring a 510(k) clearance, the process usually takes about 90 days. Premarket Approval (PMA) for high-risk devices can take longer, often several months to a year.
These timelines can vary based on the specifics of the product and the quality of the application submitted.
A 510(k) submission is a premarket notification required for certain medical devices to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This process is used for moderate-risk devices (Class II) and is less stringent than the Premarket Approval (PMA) process required for high-risk devices.
To report an adverse event or problem with an FDA-regulated product, you can use the FDA's MedWatch program:
Online: Submit a report through the MedWatch Online Voluntary Reporting Form.
By Mail or Fax: Download the MedWatch form, complete it, and send it to the FDA.
Reporting adverse events helps the FDA monitor product safety and take necessary actions to protect public health.
FDA regulations and guidance documents are available on the FDA's official website:
Regulations: Access the Code of Federal Regulations (CFR) Title 21 for FDA regulations.
Guidance Documents: Find guidance documents by product area on the FDA Guidance Documents page.