Regulatory Strategy

Background

ECI was engaged by a medical device manufacturer to provide regulatory consultation to support a new product development project involving multiple medical devices including features for interoperability and artificial intelligence.

Approach and Solution

An ECI Principal Regulatory Consultant with a strong scientific background in software, worked collaboratively with the client's team to provide regulatory consultation and identify options for regulatory pathways based on the client's strategic business requirements. The product development timeline defined specific features and functions that may impact the classification of the system which consisted of multiple medical devices with evolving indications for use.

ECl's Regulatory Consultant was formerly an FDA Reviewer who indicated multiple regulatory submissions were required to support the company's market entry timeline and ultimate device intended use.

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Comprehensive Action

ECI regulatory participation in numerous product development team meetings provided input into several essential elements of the Quality Management System (QMS) documentation.

Feedback was provided for the following:

• Project Plan
• Risk Management Plan
• Device Risk Characterization
• Device Description
• Design Inputs
• Human Factors
• Software Development Plan
• Product Claims
• Device Labeling

A comprehensive approach to regulatory requirements included consideration and review of key elements within the company's Quality Management System procedures.

Recommendations were provided to identify missing elements and provide adequate training across the organization.

Additionally, the following deliverables were generated for the client:

• 513(g) Request for Information
• Response to FDA inquiries
• Literature Summary
• Regulatory Plan
• Applicable Standards and FDA Guidance
• List of Regulatory Deliverables for Premarket Submissions

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Results

ECI provided a comprehensive regulatory strategy for device classification and submission pathway for each product type per its proposed indication for use. Product claims were clearly defined, as well as applicable FDA guidance and standards for consideration. As part of the regulatory strategy, a 513(g) Request for Information was assembled and the company successfully obtained the agency's views and confirmation about the classification and the regulatory requirements applicable for its initial product release.

Q-Sub preparation is further underway to familiarize the FDA about the company's next generation product in anticipation for multiple submissions planned. The company is seeking specific feedback to support its artificial intelligence feature from the Agency.