The main challenge for device classification evaluation lies in the subjectivity and complexity of the FDA regulatory framework. This leads to several hurdles that companies and regulators face:
The FDA classification system relies on specific rules and criteria to categorize devices into different classes (I, II, III). However, some key terms and concepts within these rules can be open to interpretation, leading to potential inconsistencies and disagreements between companies and the FDA. We decipher the FDA’s cryptic regulations, demystifying the classification process for complete peace of mind.
Classification directly impacts the level of premarket requirements a device needs to fulfill. Lower risk class devices generally require less rigorous regulatory controls, while higher risk classifications demand more extensive testing and clinical data. Our seasoned experts draw on extensive experience and a deep understanding of the ever-evolving regulatory landscape to confidently pinpoint the appropriate class of your device.
Manufacturers and regulatory agencies alike, may face limitations in resources dedicated to classification evaluation. This can lead to delays in the review process, especially for newer or more complex devices requiring in-depth assessment. We streamline the process, saving you valuable time and resources to focus on what matters most – bringing your life-changing technology to the world.
Eliminate the guesswork and anxiety. The rationale behind specific classification decisions might not always be fully explained, leading to potential frustration and uncertainty. Additionally, inconsistencies in applying the rules across different devices can raise concerns about fairness and predictability. AlvaMed provides the roadmap you need to navigate the FDA with confidence and avoid costly delays.
We work alongside you every step of the way, providing insightful guidance and proactive support to ensure your classification journey is a success.
AlvaMed provided a cost-effective approach to meeting the client’s regulatory requirements for US Agent service. As the company grew, they opened their own US subsidiary to serve as their in-house sales and distribution office. AlvaMed smoothly transitioned US Agent responsibilities to the US subsidiary once the client was ready.
Can’t say thanks enough for digging through your old files – but for your suggestion to revisit this topic, we’d still be looking at 1,360 devices for E&L and biocomp testing. So, thank you.
CereVasc, LLC
Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.
MedTech Client
The FDA classifies medical devices into three classes (I, II, and III) based on the level of risk they pose to patients. This risk assessment considers factors like:
While the 513(g) process doesn’t directly determine a device’s classification, it can be a valuable tool for obtaining information that aids in classification decisions.
Here’s how it works:
Remember, the 513(g) response is not a binding classification decision. It’s an informal guidance to help you navigate the process. However, it can be useful for:
The classification directly impacts the premarket requirements your device must meet before being marketed. Class I devices generally have the least stringent requirements, while Class III devices require the most extensive testing and clinical data.
Empower your medical breakthrough with Keira’s expert device classification guidance. We navigate the intricate FDA landscape, ensuring your innovation finds the perfect regulatory fit and paves the way for a swift, compliant market launch.
Schedule a meeting with Keira to see how AlvaMed guide your market path through regulatory approvals.
