Clinical Scorecard: Understanding FDA Pathways for MIGS

At a Glance

Key Highlights

• FDA oversight enhances patient safety and innovation.
• Approval timelines differ significantly between drugs (12 years) and devices (3-7 years).
• Class I devices require minimal review; Class II devices follow the 510(k) pathway; Class III devices require PMA.
• PMA-approved devices are typically supported by Level I evidence, aiding reimbursement.
• Prospective randomized controlled trials are essential for 510(k) devices to improve negotiation with payors.

Guideline-Based Recommendations

Diagnosis

• Evaluate the need for MIGS based on glaucoma severity and patient-specific factors.

Management

• Consider the regulatory pathway of devices when selecting MIGS options.

Monitoring & Follow-up

• Assess clinical outcomes and patient safety post-MIGS intervention.

Risks

• Devices cleared through the 510(k) pathway may face reimbursement challenges due to reliance on less rigorous evidence.

Patient & Prescribing Data

Glaucoma patients eligible for surgical intervention.

MIGS devices vary in regulatory approval, impacting safety evidence and reimbursement.

Clinical Best Practices

• Stay informed about the regulatory status of MIGS devices.
• Advocate for stronger evidence generation for newer devices lacking PMA-level data.
• Utilize preclinical studies to predict clinical outcomes for MIGS devices.

Related Resources & Content

• Van Norman GA. Drugs, devices, and the FDA: part 1: an overview of approval processes for drugs.
• Van Norman GA. Drugs, devices, and the FDA: part 2: an overview of approval processes: FDA approval of medical devices.