Follow Us

USA: FDA, 510(k), Listing and more

Home FAQ
Common Questions

MD registrations in USA

A 510(k) is the most common premarket submission required by the U.S. Food and Drug Administration (FDA) for medical devices. Its purpose is to demonstrate that a new device is substantially equivalent to a legally marketed device (known as a predicate device) already available in the United States.

Unlike CE Marking, which focuses on conformity with the European Medical Device Regulation (MDR), the FDA 510(k) pathway requires manufacturers to compare their device with an existing product and demonstrate that it has the same intended use and similar technological characteristics, so that it is substantially equivalent to the predicate device.

The quality of the technical documentation, performance testing, biocompatibility, software validation, electrical safety, usability engineering, and other supporting evidence plays a crucial role in the effort needed to obtain the FDA clearance.

Can Maytal support my FDA 510(k)?

Yes. Maytal provides complete regulatory support throughout the FDA 510(k) process, including:

  • Regulatory strategy development
  • Product classification
  • Predicate device identification
  • Review of technical documentation and gap analysis of the documentation in order to prepare the 510(k) successfully
  • Preparation of the 510(k) application using eSTAR format
  • FDA correspondence management
  • Responses to Additional Information (AI) requests
  • Support until FDA clearance is obtained

Our objective is to minimise your internal workload while maximising the chances of a successful first-time submission.

Device Listing is the process of registering each medical device marketed in the United States with the FDA.

Once a manufacturer has completed its Establishment Registration, every medical device that will be commercially distributed in the U.S. must be listed with the FDA.

The Device Listing includes information such as:

  • Product name
  • Proprietary name
  • FDA Product Code
  • Regulatory pathway
  • Manufacturing establishment
  • Commercial distribution information

Maintaining accurate Device Listings is an ongoing regulatory obligation and must be updated whenever significant changes occur.

Maytal can manage the complete Device Listing process on your behalf, ensuring full FDA compliance.

The Global Unique Device Identification Database (GUDID) is the FDA's public database that stores identification information for medical devices marketed in the United States.

Manufacturers required to comply with the FDA's Unique Device Identification (UDI) regulations must submit device information to GUDID. The database contains key product details such as:

  • Device Identifier (DI)
  • Product description
  • Brand or proprietary name
  • FDA Product Code
  • Packaging configurations
  • Sterility information
  • MRI safety status (where applicable)
  • Issuing agency information
  • Company and contact details

It is important to note that GUDID is not the same as FDA Device Listing. While Device Listing identifies the manufacturers and the devices they market in the United States, GUDID specifically contains the Unique Device Identification (UDI) information used to improve traceability, patient safety, post-market surveillance, and supply chain efficiency.

Manufacturers must ensure that GUDID records remain accurate and are updated whenever relevant device information changes.

Can Maytal manage FDA GUDID submissions?

Yes. Maytal supports manufacturers with the complete UDI implementation process, including UDI strategy, Device Identifier (DI) assignment, GUDID submissions, data maintenance, and alignment with FDA UDI requirements. We also help companies harmonise their UDI strategy across multiple markets, including the European MDR, UK, and other international jurisdictions.

FDA Establishment Registration is the mandatory registration of companies involved in manufacturing, sterilising, repackaging, relabelling, importing, or distributing medical devices in the United States.

Foreign manufacturers must complete Establishment Registration before marketing their products in the U.S.

The registration must be renewed every year between 1 October and 31 December.

Failure to maintain an active registration may prevent products from entering the U.S. market.

Maytal supports manufacturers throughout the entire Establishment Registration process and ensures annual renewals are completed on time.

Foreign medical device manufacturers are legally required to appoint a U.S. Agent before completing FDA Establishment Registration.

The U.S. Agent acts as the official communication point between the FDA and the foreign manufacturer.

Responsibilities include:

  • Receiving FDA communications
  • Assisting during FDA inspections
  • Responding to regulatory enquiries
  • Facilitating communication between FDA and the manufacturer

A reliable U.S. Agent is essential for maintaining regulatory compliance in the United States.

Can Maytal provide US Agent services?

Yes. Through our trusted international partner network, Maytal can provide fully compliant U.S. Agent services for manufacturers located outside the United States.

A U.S. Importer is the company responsible for importing medical devices into the United States.

Depending on your commercial model, the importer may have regulatory obligations, including maintaining records and ensuring products comply with FDA requirements.

The choice of importer is often an important commercial decision, as it may influence logistics, distribution strategy, customer support, and post-market activities.

Can Maytal help identify a suitable US Importer?

Yes. Through our network of commercial and regulatory partners, Maytal can introduce experienced U.S. Importers suitable for your products and business strategy.

The De Novo pathway is intended for innovative low-to-moderate risk medical devices for which no legally marketed predicate device exists.

Instead of demonstrating substantial equivalence, manufacturers must demonstrate that general controls, or general and special controls, provide reasonable assurance of safety and effectiveness.

Once granted, the De Novo classification establishes a new product type that future manufacturers may use as a predicate for future 510(k) submissions.

Maytal supports manufacturers throughout the complete De Novo process, including regulatory strategy, documentation preparation, clinical evidence planning, and FDA interactions.

Premarket Approval (PMA) is the FDA's most rigorous regulatory pathway and is generally required for Class III medical devices that present the highest level of patient risk.

Unlike the 510(k) pathway, PMA requires comprehensive scientific evidence demonstrating both safety and effectiveness.

A PMA submission may include:

  • Clinical investigations
  • Laboratory testing
  • Biocompatibility
  • Software validation
  • Risk management
  • Manufacturing information
  • Design verification and validation
  • Quality system information and FDA audit

Because PMA submissions are highly complex, early regulatory planning is essential.

Can Maytal support PMA submissions?

Yes. Maytal supports manufacturers from the earliest regulatory strategy discussions through clinical planning, technical documentation preparation, FDA meetings, submission management, and responses during FDA review.

The FDA Q-Submission Program allows manufacturers to obtain FDA feedback before submitting a 510(k), De Novo, PMA, or other regulatory application.

A Q-Submission can significantly reduce regulatory uncertainty by allowing manufacturers to discuss topics such as:

  • Regulatory pathway
  • Clinical study design
  • Performance testing
  • Software documentation
  • Cybersecurity
  • Biocompatibility
  • Usability validation

Receiving FDA feedback early in development often reduces review times and minimises costly delays.

Maytal can prepare and manage Q-Sub meetings and communications with the FDA.

eSTAR (electronic Submission Template And Resource) is the FDA's electronic submission template used for most 510(k) and De Novo submissions.

The interactive template standardises submissions, improves data quality, and helps reduce administrative review issues.

Preparing an eSTAR requires a thorough understanding of FDA expectations and supporting documentation.

Maytal prepares fully compliant eSTAR submissions for manufacturers worldwide.

The timeline depends on the regulatory pathway (Device Listing, 510(k), De Novo, PMA), the quality of the submission, and the complexity of the device.

Typical review times are:

  • Device Listing and Establishment Registration: 15 days – 1 month
  • 510(k): approximately 4–8 months
  • De Novo: approximately 8–15 months
  • PMA: typically 12–24 months or longer

Well-prepared submissions generally reduce review time and minimise FDA requests for additional information.

Maytal helps manufacturers develop robust regulatory strategies and submission packages to maximise efficiency throughout the FDA review process.