FDA Requirements Compliance Hub

Premarket Submissions

Premarket applications must be submitted to the FDA before a medical device can be legally marked in the US. Submissions vary based on the device's risk level and novelty and include:

510(K) Submissions for devices substantially equivalent to existing products
Premarket Approval (PMA) for high-risk devices that must demonstrate safety and effectiveness through extensive data (often including clinical trials)
De Novo Requests for novel devices without a legally marketed predicate that require a demonstration of safety and effectiveness

Cybersecurity Design Controls

The FDA requires evidence that cybersecurity has been considered in the device's design, including the implementation of necessary security features

Vulnerability Management & Remediation

Medical device manufacturers must submit proof of vulnerability triaging in their submissions to the FDA

SBOMs

A detailed list of all software components, including third-party and open-source elements, must be maintained for each medical device to facilitate vulnerability management

Postmarket Management

Medical device manufacturers must establish processes to monitor, identify, and address cybersecurity vulnerabilities post-market

Meet Finite State, Your Partners in Compliance

Leverage expertise from former U.S. government officials and get the support you need to meet FDA requirements and release your medical devices to the US market with confidence

Automate real-time vulnerability detection in source code & binaries to identify and assess risks as they emerge
Generate SBOMs with VDR/VEX vulnerability data in industry-standard formats (CycloneDX, SPDX)
Employ continuous monitoring and alerting to ensure ongoing protection throughout a product's lifecycle

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