What Clinical Data is Required
Clinical data in 510(k) submissions
Clinical data is not always required for a 510(k). Whether clinical data is needed depends on:
- The device's risk level and device type
- Whether non-clinical data (bench testing, biocompatibility, software validation) is sufficient to demonstrate substantial equivalence
- Whether the technological differences from the predicate raise clinical safety/effectiveness questions that only clinical data can address
When clinical data is typically required for 510(k):
- Novel technological features that cannot be evaluated by bench testing alone
- Devices where performance in the clinical setting cannot be inferred from lab data
- Certain high-risk Class II devices (e.g., some IVDs, active implantables)
Clinical data in De Novo requests
Clinical data requirements for De Novo vary by device type. Because De Novo devices are novel, FDA may require clinical data when:
- Non-clinical data cannot adequately characterise the device's safety and effectiveness profile
- The proposed special controls include clinical performance requirements
Clinical data in PMA applications
PMA applications almost always require clinical data from well-controlled clinical investigations. The standard is valid scientific evidence — defined in 21 CFR § 860.7(c)(2) as evidence from well-controlled investigations, partially controlled investigations, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, and reports of significant human experience.
The pivotal study for a PMA must typically be conducted under an approved IDE.
What qualifies as valid scientific evidence
Per FDA guidance, valid scientific evidence must:
- Come from studies with appropriate controls
- Use endpoints that are clinically meaningful
- Be statistically adequate for the intended conclusions
- Be collected under conditions approximating actual use