5 Key Takeaways

• 1

  Douglas J. Rhee, MD, discussed FDA pathways for minimally invasive glaucoma surgery (MIGS) devices at the American Glaucoma Society meeting.

• 2

  FDA oversight is crucial for patient safety and innovation, with significant differences in approval timelines for drugs and devices.

• 3

  Devices are classified into three risk categories, with Class III requiring rigorous premarket approval (PMA) and Class II often following the 510(k) pathway.

• 4

  PMA-approved devices typically have stronger evidence, which aids in reimbursement, while 510(k) devices may face challenges due to less rigorous data.

• 5

  Dr. Rhee emphasized the need for prospective randomized controlled trials for 510(k) devices to improve evidence and negotiation with payors.