Are clinical data necessary to evaluate safety and effectiveness for purposes of determining substantial equivalence?
Whenever a manufacturer recognizes that clinical data are needed because bench testing or simulations are not sufficient to assess safety and effectiveness and, thus, to establish the substantial equivalence of a new design, a 510(k) should be submitted. In the case of in vitro diagnostic devices, however, clinical samples may be collected and analyzed to demonstrate that the device continues to conform to performance specifications as contained in a voluntary standard or as described in a previous 510(k). A new 510(k) is normally not necessary in this situation.
Related Questions
- How is the concept of substantial equivalence used as part of the safety assessment process? Why is DNA not included in the assessment of substantial equivalence?
- Why is it necessary to take a different approach to the assessment of safety and environmental issues?
- What are the necessary features for safety mat systems?
