What to include in non-clinical bench performance testing
In the United States, the FDA is responsible for reviewing the safety and efficacy of medical devices. Based on the complexity and intended use, medical devices are categorized into three different classes – Class I, Class II, and Class III. If not exempted, most Class II and Class III medical devices are subject to a rigorous review for safety and effectiveness under a different application submission process, which largely includes premarket notification (510(k)), premarket approval (PMA) application, and De Novo requests. Each submission requires appropriate and complete testing to be presented in a report so that the Agency can evaluate the safety and efficacy of the device.
However, applicants are often confronted with FDA identifying major deficiencies in the test report due to incomplete information.
To help applicants reduce the risk of rejection or receiving a notice of deficiencies, FDA published a new guidance document in April 2019.
The new guidance clarifies the contents and format required for non-clinical bench performance testing in premarket submissions, and explains the depth of information required.
In the following three sections we outline practice tips associated with FDA’s new guidance.