August 29, 2024
In the world of medical devices, particularly those categorized as moderate to high-risk, clinical data is a critical component of the regulatory approval process. This data, presented to regulatory authorities, forms the basis for marketing authorization in most jurisdictions.
The challenge lies in determining the adequacy of the available data and crafting a persuasive justification for its suitability. Let’s explore the criteria used to assess the suitability of three different categories of data.
The existence of published literature on a subject device, even in large quantities, may not be sufficient to support a particular marketing application. Several factors come into play:
While the FDA has published guidance on the use of RWE to support marketing applications, it remains more of a theoretical option than a practical one. Similarly, Notified Bodies (NBs) will rarely find RWE such as registry data sufficient to support EU certification.
Data originally collected for non-regulatory purposes – publication, product development, etc. – may not meet the requirements for use as supporting evidence for a regulatory submission. Before a decision is made to rely on such data, a thorough review of sponsor and site files should be conducted to ensure documentation is available to demonstrate:
Navigating the regulatory landscape for medical device approval is a complex process. Understanding the criteria for assessing the suitability of available data is crucial in crafting a compelling case for regulatory approval. By considering these factors, applicants can better position themselves for a successful regulatory outcome.
For the US market, device manufacturers should consider engaging FDA via the Q-Submission (QSub) process to obtain feedback directly from reviewers regarding suitability and sufficiency of their proposed clinical data strategy.
Ensuring your clinical data meets the stringent requirements for medical device approval can be a daunting task. Whether you’re navigating the complexities of published literature, real-world evidence, or previously conducted studies, ProPharma is here to help. Our team of experts can guide you through the regulatory maze, ensuring your data is robust, compliant, and persuasive. Contact us today to learn how we can support your medical device's path to market.
Director, MedTech Regulatory
TAGS: Medical Devices Clinical Research Solutions MedTech Clinical Data
August 1, 2024
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
November 24, 2020
Clinical data and its analysis are critical to clinical research. Ensuring the overall quality of clinical data is then paramount to ensuring quality care and appropriate decision-making in the...
October 7, 2020
In the era of technological disruption, data science is a disruptor for the books. Today’s data scientists develop processes, algorithms, and systems to mine structured and unstructured data with the...