Steps to sell in the US
US Agent guide as per FDA
Having a regulatory strategy for the determination of the FDA path (510(k), PMS, de novo) is the first step to marketing medical devices in the USA market. Our team of expert consultants in medical device and USA - FDA regulations will guide you in this process. Contact us to act as your FDA US Agent and provide you with the full service.
Identify the FDA and U.S. Regulatory Pathway
AF Pharma Service reviews your product category, intended use, claims, ingredients, technical information and target market to confirm the correct route.
Depending on the product, this may include FDA medical device classification, 510(k) clearance, De Novo or exemption assessment, FDA establishment registration and device listing, cosmetic MoCRA requirements, food supplement label and claims review, Amazon compliance documentation, or general consumer product safety requirements.
Correct classification helps avoid FDA issues, rejected Amazon listings, non-compliant claims and delays before market launch.
Appoint an US Agent
Foreign medical device establishments that register with FDA must identify a U.S. Agent as part of the FDA registration process.
AF Pharma Service provides FDA U.S. Agent services and supports companies with U.S. market access requirements for medical devices, cosmetics, Amazon products, food supplements and general consumer products.
We help manufacturers understand when a U.S. Agent, importer, distributor, responsible contact or compliance file may be required, and what information must be included in product documentation, labels and registrations.
Having the correct U.S. contact and regulatory support in place helps improve communication, reduce delays and support a smoother market entry process.
Register the Company, List the Product and Prepare the Compliance File
Once the U.S. regulatory pathway is confirmed, the required registration, listing or compliance documentation must be prepared.
AF Pharma Service supports companies with FDA establishment registration, device listing, 510(k) support, De Novo support, MoCRA cosmetic registration support, label review, claims assessment, Amazon compliance files and product safety documentation.
Depending on the product, this may include:
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FDA establishment registration and device listing;
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510(k), De Novo or exemption assessment;
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cosmetic facility registration and product listing support under MoCRA;
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food supplement label and Supplement Facts review;
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claims review under U.S. requirements;
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product safety documentation for general consumer products;
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Amazon documentation packs and restricted product support.
A complete compliance file helps reduce questions from FDA, importers, distributors, Amazon and other marketplace or regulatory stakeholders.
Confirm Importer, Labelling and U.S. Market Readiness
Before selling in the USA, companies must confirm that product labels, importer information, claims, warnings and documentation are suitable for the U.S. market.
AF Pharma Service supports the review of medical device labels and IFUs, cosmetic labels, Supplement Facts panels, Amazon listings, warnings, instructions for use, importer details and product compliance evidence.
For medical devices, we also help identify the correct role of the initial importer, distributor and U.S. Agent in the FDA registration and listing process.
For cosmetics, supplements, Amazon products and general consumer products, we review the product information to help ensure that claims, labelling and safety documentation are aligned with U.S. market expectations.
Once the regulatory pathway, U.S. contact, registration or listing requirements and product documentation are in place, the product can move toward U.S. market access with greater confidence.
US Agent services for medical devices
Welcome to AF Pharma for navigating the intricate landscape of FDA regulations for medical devices in the USA. As the premier US Agent, we specialize in guiding manufacturers through the complexities of FDA compliance, ensuring a seamless pathway for your product's entry into the market. With our wealth of experience and expertise, we excel in crafting essential FDA documents, including 510(k) submissions, essential for your device's approval. We understand that comprehending FDA regulatory strategies is pivotal for manufacturers, and our team of expert consultants is here to support you at every turn.
Determining the optimal FDA pathway is the cornerstone of regulatory compliance. Whether it's through 510(k) clearance, Post-Market Surveillance (PMS) requirements, or the innovative de novo pathway, our consultants collaborate closely with you to tailor a regulatory strategy aligned with your device's characteristics and intended use. When it comes to preparing FDA documentation, such as 510(k) submissions, our proficiency is unmatched. We possess an in-depth understanding of FDA expectations, encompassing clinical data, performance testing, and risk assessment. Additionally, we offer guidance on alternative regulatory pathways, such as the de novo process or PMS requirements, ensuring your compliance while maximizing market entry success.
At AF Pharma, we're committed to delivering exceptional regulatory consulting services, supporting you throughout the FDA clearance journey. Let us streamline your regulatory process, saving you time and resources while guaranteeing compliance and market triumph. Trust AF Pharma to be your steadfast partner as you introduce your medical device to the thriving US market.