What is the difference between PMA and 510(k)?

The PMA process is more rigorous and is designed for high-risk devices that require substantial clinical evidence, compared to the 510(k) process, which is aimed at demonstrating substantial equivalence to existing devices.

How long does the PMA process typically take?

The PMA review process can take between six months to several years, depending on the complexity of the device, the completeness of the application, and FDA feedback.

What happens if my PMA is rejected?

If the FDA rejects the PMA, you can request a discussion with regulatory reviewers to understand the reasons and consider alternative pathways, including modifications to the device or reapplication.