Background

ECI was engaged by a small medical device manufacturer that provides connectivity and interoperability solutions including a cloud-based platform to hospitals that enable enterprise telehealth. Their product offerings provide dedicated software modules for patient data display, record and storage for continuous monitoring capabilities from various medical systems, clinical decision support and artificial intelligence applications for various specialties including intensive care, general hospital, cardiology, neurology among others.

Objective

The client was actively pursuing market expansion requiring reclassification from a Class I to Class II device to expand the product features and claims. ECI was contracted to conduct a comprehensive assessment of the product’s technological features, its intended use, risks and the current regulatory landscape. During the first phase, ECI performed a thorough gap assessment on the state of the company’s quality management system documentation to determine readiness for compilation of a premarket submission.

During the second phase, ECI produced a regulatory strategy which was used for the following:

• to define the regulatory classification for each product
• to support reclassification for those products with expanded indication,
• to prepare US premarket applications, and
• to communicate significant regulatory risks, compliance observations, and post-market requirements.

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ECI Engagement

ECI consultation services were provided by a Regulatory Affairs Manager with decades of industry experience and a Principal Regulatory Consultant, who was a former FDA reviewer with a strong scientific background in software.

As part of the gap assessment, the client had assembled documentation for an interactive review of its Quality Management System (QMS). ECI made numerous requests for additional information on the evidence provided to demonstrate conformance to product design controls. At the conclusion of the gap assessment phase, ECI delivered a report outlining recommendations on a number of aspects including:

• Recommendation to support marketing claims per its defined indications for use
• Requirements to support the Total Product Life Cycle including change control, complaint handling and medical device reporting
• Remediation recommendations
• Requirements related to the Health Insurance Portability and Accountability Act (HIPAA) Privacy rules
• Personnel training.

ECI produced a comprehensive regulatory strategy for the second phase of the project.  This document provided:

• Detailed description of each product’s design such as its components, materials, principle of operation and intended use
• Determination of each device classification and identification of potential predicate devices to support a substantial equivalence determination
• Identification of all regulatory entities that have oversight for the product type including a cloud-based platform, with an emphasis on state laws for privacy and security rules as well as other applicable topics
• Compilation of regulatory requirements for each product including applicable standards and FDA guidance, as well as the most relevant guidance from the Health and Human Services (HHS), Office of the National Coordinator for Health Information Technology (ONC), Cybersecurity and Infrastructure Security Agency (CISA), and the National Institute of Standards and Technology (NIST)
• Recommendations to address non-compliance risk
• List of regulatory deliverables for premarket submissions.

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Results

ECI generated a comprehensive regulatory strategy for device classification and submission pathway for each product type. Product claims were clearly defined, as well as applicable FDA guidance and standards for consideration. The client was also provided with recommendations and tips to support their goal for market expansion. Based on the gap assessment, ECI identified improvements to ensure a robust QMS to support a successful premarket application and ensure products meet the regulatory controls per the Federal Food, Drug and Cosmetic Act.