The FDA regulates medical devices, food products, and other consumer goods in the US market. Our expert team provides comprehensive support for FDA registration, 510(k) submissions, and ongoing compliance requirements.
Premarket notification for medical devices
Facility and device listing requirements
Quality System Regulation implementation
Post-market reporting and compliance
Understanding the three classes of medical devices
Low Risk
Simple devices with minimal potential for harm. Most are exempt from premarket notification.
Moderate Risk
More complex devices requiring special controls and typically 510(k) clearance.
High Risk
Life-supporting or life-sustaining devices requiring premarket approval (PMA).
Systematic approach to US market entry
Device classification, predicate identification, and regulatory pathway determination for optimal market entry strategy.
Facility registration and device listing with the FDA, including establishment of US Agent if required.
Comprehensive premarket notification preparation including substantial equivalence demonstration and testing protocols.
Quality System Regulation compliance including design controls, CAPA, and risk management procedures.
FDA review process management and clearance letter receipt, enabling legal marketing in the US.
Understanding the regulatory framework for US market access
Establishes requirements for quality systems for medical device manufacturers.
Requirements for PMA submissions for Class III devices.
Facility registration and device listing requirements.
Preventive controls for human food facilities.
Current good manufacturing practice regulations.
Requirements for food labeling and nutrition facts.
Safety and labeling requirements for cosmetic products.
Labeling requirements and ingredient declarations.
Modernization of Cosmetics Regulation Act: US agent, facility registration, product listing, safety substantiation, and adverse event reporting.
Real results from our FDA compliance expertise
Full FDA registration and FSMA compliance for a multi-product supplement range.
FDA registration and labeling compliance for packaged snack products entering the US market.
Facility registration and product listing for beverage lines with full FDA compliance.
FDA registration and Grade A compliance for dairy products exported to the US.
Low-acid canned food registration and process filing with FDA for shelf-stable products.
FDA registration and food safety compliance for spice blends and condiment products.
Let our FDA experts guide you through the regulatory process