Registration in the USA

The U.S. medical device market represents approximately 40% of the global market by value, making it a primary target for any manufacturer seeking international sales with a single registration.

To legally distribute and market Class I, II, or III medical devices in the USA, manufacturers must determine the appropriate device classification and complete product and establishment registration with the FDA, following the procedures best suited to their product type.

Maytal supports medical device manufacturers in preparing the various activities required for U.S. market entry:

Pre market Notification: 510(k), Pre-Submission

Manufacturers wishing to introduce Class II devices, and certain Class I and III devices, must submit a 510(k) premarket notification to the FDA.

A 510(k) is also required for significant changes affecting the safety or effectiveness of already FDA-cleared products, such as modifications to intended use, technology, or design.

With over 10 years of experience working with the FDA, Maytal assists manufacturers through three key steps for a successful 510(k):

• Gap analysis: Reviewing or redefining intended use for the U.S. market, identifying predicate devices, relevant FDA guidance and standards, assessing existing documentation, estimating likelihood of success, and proposing alternative or cautious approaches (e.g., Pre-Submission or De Novo).

• Technical-regulatory consulting: Supporting the preparation or adjustment of existing documentation, including software validation, cybersecurity, usability validation, biocompatibility, and labeling updates.

• 510(k) dossier preparation: Compiling and submitting the complete 510(k) file to the FDA and assisting the manufacturer in addressing FDA objections until clearance is obtained.

Maytal can also perform Small Business Qualification to reduce application fees for SMEs.

Classification, Establishment Registration, Device Listing, and GUDID

All devices intended for the U.S. market, regardless of class, must be registered with the FDA before sale. Maytal supports manufacturers by:

• Evaluating classification and selecting appropriate Product Codes, particularly for first-time Class I device registrations.

• Completing Establishment Registration by entering required details into the FDA portal.

• Submitting the Device Listing, assisting with grouping devices to minimize registration burden and correctly register proprietary names consistent with technical and commercial documentation.

• Supporting GUDID registration for applicable devices.

U.S. Agent Services

A U.S. Agent is required to act as the FDA contact for the manufacturer in the United States. Maytal can serve as the manufacturer’s U.S. Agent.

Additional Regulatory Submissions

Maytal also supports any other FDA submissions required for market access depending on device class:

• De Novo Applications

• Humanitarian Device Exemption (HDE) Applications

• Premarket Approval (PMA) Applications

• Investigational Device Exemption (IDE) Applications

This comprehensive approach ensures a smooth, compliant, and efficient entry into the U.S. medical device market.