FDA Certification

FDA Certification

FDA Approval FDA Approval is an indication of a product’s adherence to the standards set by the U.S. Food and Drug Administration FDA, one of the world’s most reliable regulatory agencies governing the safety and effectiveness of products. For instance, this is especially important for pharmaceutical products (drugs), medical devices, vaccines, biologics and certain food and cosmetic products which can affect the public health. Registration with the FDA is mandatory for any company planning to manufacture, sell, or market these products in the US. USFDA Listing also ensures that facilities and products.

Unlike the FDA approval which requires lengthy and comprehensive reviews with associated clinical trials, USFDA Listing ensures that facilities and products are properly registered and meet basic compliance standards for legal entry into the U.S. market.

Key Features of FDA Listing

  • 1. Regulatory Compliance: Companies must register their facilities and list their products with the FDA to comply with U.S. laws and regulations.
  • 2. Basic Requirement: USFDA Listing is mandatory for manufacturers, importers, packagers, and distributors of medical devices, food products, and drugs.
  • 3. Simplified Process: Unlike FDA approval, the listing process does not require clinical data or performance testing but focuses on facility registration and product classification.
  • 4. Annual Renewal: USFDA listings must be renewed annually to maintain compliance with U.S. regulatory requirements.

FDA Listing Process

  • 1. Facility Registration: Companies must register their manufacturing, testing, sterilization, or distribution facilities with the FDA.
  • 2. Product Listing: After facility registration, companies must list each product, including its intended use and product category, with the FDA.
  • 3. Compliance Review: Companies must ensure compliance with relevant FDA regulations, such as proper labelling, safety information, and product categorization.
  • 4. Renewal and Updates: Companies must annually renew their USFDA registration and update their product listings to reflect any changes.

Importance/Implications of FDA Listing

  • 1. Market Access: Essential for legally selling or distributing products in the U.S.
  • 2. Regulatory Compliance: Demonstrates that facilities and products are recognized under U.S. FDA regulations.
  • 3. Streamlined Entry: Simplifies the process for low-risk products while ensuring compliance with safety and quality requirements.
  • 4. Consumer Trust: Provides assurance that the product and facility comply with federal regulatory guidelines.

FDA Listing is the cornerstone of public health and a passport for businesses to enter into the fiercely competitive U.S. market with consumers knowing they can rely on the safety and reliability of our products.

Major Product Categories for FDA Listing

  • Medical Devices
  • Drugs
  • Food and Agro Products
  • Cosmetics
  • Biologics
  • Veterinary Products
  • Radiation-Emitting Products
  • Tobacco Products
  • Combination Products
  • Human and Animal Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Key Services Offered by Seven Steps

  • Medical Device Establishment Registration & Listing
Companies involved in manufacturing, testing, packing, labeling, sterilization, or import of medical devices are required to register their facility and list their devices with the FDA. Seven Step Consulting Pvt Ltd offers FDA medical device registration and listing services. We provide expert guidance on all regulatory requirements for medical devices. Our complete solution supports you until you meet all FDA medical device regulations.
  • Pre-Market Notification (510(k))
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective as an existing (predicate) device. Rare Class I and most Class II devices require a 510(k). The organization must demonstrate that the new device is substantially equivalent to a predicate device in terms of intended use, technological characteristics, and performance testing. SEVEN STEP CONSULTING PVT LTD provides complete assistance for Pre-Market Notification 510(k).
  • Medical Device Labeling
The FDA requires medical device labels to include adequate instructions for use, warnings, servicing details, and other critical information to ensure the safe and effective use of the product. Seven Step Consulting Pvt Ltd helps ensure your device’s labeling complies with all FDA regulations.

Why Choose Seven Steps Consultancy?

Ready to launch your product on the U.S market with FDA approval? With Seven Steps Consultancy Pvt. Ltd., you can have the peace of mind that comes from knowing you have a trusted partner navigating the complex FDA regulatory landscape. Our team is trained on everything from facility registration to device labeling and 510(k) premarket notifications—providing you end-to-end support to meet the strictest safety and compliance standards for your product.

Whether you’re looking to obtain approval for medical devices, drugs or food products, we expedite the process to save you to save you time and resources. Let Seven Steps Consulting Pvt. Ltd. help you achieve FDA compliance and successfully access the U.S. market.

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