US FDA 510(k) Submission

Regulatory Agency :

The U.S. medical device market is regulated by the Center for Devices and Radiological Health (CDRH), part of the FDA. Learn more about the CDRH.

Medical Device Regulations & Guidance Documents :

• Code of Federal Regulations – Title 21 – Food & Drugs : Includes numerous regulations impacting medical devices.Learn more about Title 21.
• FDA Guidance Documents Provide detailed instructions on various regulatory processes Explore FDA Guidance Documents.

FDA Medical Device Classifications :

Devices in the U.S. are classified based on risk :

• Class I : Lowest risk, general controls only (e.g., tongue depressors).
• Class II : Higher risk, general and special controls (e.g., catheters).
• Class III : Highest risk, requires pre-market approval (e.g., heart valves).

FDA Medical Device Market Requirements :

Four major steps to market :

• Classify your device.
• Prepare the appropriate pre-market submission, including using the eSTAR electronic submission program for 510(k) and De Novo submissions.
• Send your submission to the FDA and comply with regulatory controls. Most Class II and III devices require a pre-market quality system inspection as defined in 21 CFR part 820.
• Understand submission types: 510(k), PMA, and De Novo.How to find and effectively use predicate devices.

FDA Post-Market Requirements :

Defined in 21 CFR 822, including surveillance under section 522 of the FD&C Act. Guidance for Post-market Surveillance.

FDA UDI Requirements :

Mandates UDI labeling and data submission in the GUDID Unique Device Identification System and Policy Regarding Compliance Dates.

Standards and Conformity Assessments in the U.S :

The FDA encourages using FDA-recognized consensus standards in premarket submissions. Standards and Conformity Assessment Program.

SFDA Medical Device Registration Fees :

Fees for 2024 include establishment registration, 510(k), PMA, De Novo Classification Request, and annual fees for periodic reporting on class III devices. Who Must Register, List, and Pay the Fee and Reduced Medical Device User Fees for Small Businesses.

How Medfins will help you !

At Medfins International, we are dedicated to guiding you through the complexities of the U.S. medical device market. Our experts are proficient in FDA regulations and offer comprehensive support at every stage, from device classification to market authorization and post-market requirements.

• Tailored Regulatory Strategy: : We develop customized strategies to ensure your medical devices comply with all pertinent FDA regulations, aiming to minimize the risk of market entry delays in the United States.
• Compliance and Submission Support : Our team provides assistance in preparing and submitting essential documentation for FDA approvals, including 510(k), PMA, and De Novo submissions, ensuring strict adherence to FDA’s demanding standards.
• Post-Market Surveillance Guidance : We offer advice on establishing effective post-market surveillance systems in compliance with FDA mandates, crucial for maintaining market presence and fulfilling post-market surveillance obligations.
• Ongoing Regulatory Support : Stay informed of regulatory changes with our continuous monitoring and advisory services, ensuring your sustained compliance with FDA medical device regulations.