During the evaluation of pre-market approval applications or de novo petitions, the FDA relies upon scientific evidence to assess safety and effectiveness of the device. Experts consider clinical and non-clinical data to gauge the benefits and risks of granting approval.
The new guidance includes the device reviewer’s worksheet, detailing several areas the reviewer considers. These areas include:
• Magnitude of the risks or benefits
• Duration of the risks or benefits
• Probability that patients will experience the risk
• Patient tolerance for risks
• Availability of alternative treatment
• Value the patient places on treatment
The FDA will also increase transparency of the decision-making process with the Summary of Safety and Effectiveness Data for PMAs and additional decision summary review memos for de novo decisions.
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