Bringing a medical device to market in the United States requires navigating a complex regulatory landscape, primarily regulated by the Food and Drug Administration (FDA). Understanding the classification, regulatory pathways and compliance requirements is critical to success.
At D.med Technologies, we specialise in guiding manufacturers through every step of this process, ensuring that your product meets all the necessary standards to efficiently reach the market.
Understanding FDA medical device classifications
The FDA classifies medical devices into three categories based on risk:
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Class I:
Low risk, subject to general controls with many exemptions from 510(k) premarket notification. Examples: Bandages, Examination Gloves, External Prosthetics, etc.
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Class II:
Moderate risk, requiring both general and special controls, with most devices needing a 510(k) submission. Examples: Infusion Pumps, Blood Pressure Monitors, Hearing Aids, etc.
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Class III:
High risk, requiring premarket approval (PMA) with clinical evidence to demonstrate safety and efficacy. Examples: Pacemakers, Heart Valves, Coronary Stent, etc.
Determining the correct classification is the first step in your regulatory journey. Incorrect classification can lead to delays and increased costs. We can help you accurately classify your device and avoid potential complications.
Establishing a quality management system (QMS)
Compliance with 21 CFR Part 820, which outlines the FDA’s Quality System Regulation (QSR), is mandatory for medical device manufacturers.
Implementing a robust QMS is essential to ensure product quality and regulatory compliance. Our team can help you develop and refine your QMS to meet FDA requirements, including ISO 13485 certification and Medical Device Single Audit Program (MDSAP) readiness.
Choosing the correct regulatory pathway
The regulatory pathway you choose will depend on the classification of your device and the nature of your product.
Here’s a breakdown of the most common pathways:
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510(k):
Required for Class I and II devices that are not exempt from premarket review. This submission demonstrates that your device is substantially equivalent to a legally marketed predicate device.
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Premarket approval (PMA):
Required for Class III devices, which require extensive clinical studies to demonstrate safety and effectiveness.
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De Novo:
Suitable for novel devices without a predicate, providing a pathway to Class I or II classification after demonstrating reasonable assurance of safety and effectiveness.
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Humanitarian Device Exemption (HDE):
For devices targeting diseases that affect fewer than 8,000 people in the US annually, with reduced clinical data requirements compared to a PMA.
Each pathway has its nuances, particularly in terms of the clinical data required.
Preparing and submitting premarket documentation
Premarket submissions to the FDA require thorough documentation, including clinical and non-clinical data, labelling information, quality system documentation and, in some cases, Q-Submissions to facilitate early interaction with the FDA for selected areas such as Usability Engineering, Cyber Security, etc. In addition, with the increasing focus on digital security, the FDA released its final guidance on medical device cybersecurity in September 2023.
The document, entitled ‘Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions’, outlines the required cybersecurity-related information that must be included in submissions to the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER). This guidance applies to any device or software that can connect to the Internet and is vulnerable to cybersecurity threats, particularly those that contain software or programmable logic components. Ensuring compliance with these guidelines is critical to protecting against potential cyber risks.
Our experts can assist you in compiling and organising this documentation to ensure a smooth submission process. We will also guide you through the Q-Sub process if additional FDA input is required prior to formal submission.
FDA review, approval and post-market requirements
Once your submission is complete, the FDA will review it, which may include inspections of your facility to ensure compliance with the QSR.
After clearance or approval, you must register your facility and list your device. We support you through this final stage, ensuring that all regulatory requirements are met so that you can confidently bring your product to market.
How D.med Technologies can help
We are your associate in navigating the FDA’s complex regulatory environment. Our partnership includes:
– Device Classification Consulting:
We help you accurately classify your device and identify similar or equivalent devices on the market.
– QMS Consulting:
From full QMS implementation to consulting on specific processes, we ensure your system complies with FDA regulations.
– Cybersecurity consulting:
Protect your device from cybersecurity threats with our specialised consulting services.
– Verification & Validation Services:
We perform usability testing and other verification and validation activities critical to FDA approval.
– Clinical Trial Management:
Our team has extensive experience in clinical trial management, from patient recruitment to data analysis.
– Regulatory Affairs Consulting:
We can guide you through every step of the regulatory process, from registration pathway, pre-market submission to post-market surveillance.
Partner with us to navigate the FDA regulatory landscape with confidence and bring your medical device to market successfully. Contact us here.
Marcel Ksoll
Q&R Manager & Project Manager
“With seven years as a Quality and Regulatory Manager in the medical device industry, I specialise in navigating FDA and MDR regulations for Class II and III active devices. I have experience managing EU to US registrations and ensuring compliance across global markets, including Asia, South America, and Africa. My expertise covers transitioning devices from MDD to MDR certification, guiding regulatory submissions such as 510(k), PMA, and MDR certifications, and assisting manufacturers early in the development process with determining the intended use, appropriate device classification, and selecting the right regulatory pathway.
Additionally, I oversee ISO 13485 certification, managing Quality Management System setup, conducting internal audits, and leading external audits.”
