FDA Publishes Guidance for Pre-Market Approvals

The Food and Drug Administration published guidance for medical device manufacturers that describes how the benefits and risks of certain medical devices are considered during the pre-market review.

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.

More Articles on the FDA:

17 Spine Devices Receive FDA 510(k) Clearance in February

44 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in February

Globus Medical Settles FDA Administrative Complaint


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