Overview of 513 G
In the US, clinical medical devices are classified based on a predicate framework, comparing them with legally marketed devices to determine Class I, II, or III according to risk.
To help manufacturers determine their device’s classification or find substantially equivalent (SE) devices, the FDA provides a classification database.
If no SE is found, manufacturers can request FDA’s guidance on device classification via Section 513(g) under the FD&C Act, by submitting a written 513(g) application to CDRH.
Expertise
- Guidance on likely device class from 513(g) requests, excluding:
- Review of information related to substantial equivalence or device safety and efficacy
- Recommendations for nonclinical, animal, or clinical testing to support clearance or approval
- Maven assists in preparing and reviewing 513(g) applications, identifying information requirements, and providing regulatory support throughout the process.
Advantages
- Access FDA classification database to determine device class or SE
- Structured process for submitting 513(g) requests when SE is not found
- Expert review of applications to ensure compliance with FDA requirements
- Regulatory support for preparation and audit of submissions
Maven Expertise in 513 G
- Identifying the need for a 513(g) submission
- Preparation and review of 513(g) applications
- Medical device classification support
- FDA communication assistance
Maven Advantage
- Proven ability to navigate complex regulatory challenges
- Local presence to facilitate communication with FDA
- Post-decision support for device approval
