Overview

Navigating the FDA’s regulatory pathways can be complex—especially when a product’s classification evolves mid-development. This case study highlights how a wound care innovator successfully transitioned from a 510(k) strategy to a full Premarket Approval (PMA), ultimately securing FDA clearance for a novel therapeutic device.

This white paper is essential reading for regulatory professionals, clinical strategists, and product developers working in the advanced wound care space.

What You’ll Learn

Initial Classification Challenges

The sponsor initially pursued a 510(k) pathway, believing their product was substantially equivalent to an existing wound dressing. However, early FDA feedback indicated that the product’s mechanism of action and risk profile warranted a higher level of scrutiny.

This section explores:

• How predicate selection impacted the initial strategy
• FDA’s rationale for reclassification
• Lessons learned from early misalignment

Regulatory Strategy Shift

Faced with a classification change, the sponsor had to pivot quickly. With Amarex’s support, the team developed a PMA-ready regulatory strategy, including:

• A revised clinical development plan
• Enhanced risk mitigation protocols
• A new FDA engagement roadmap

This section outlines how the sponsor adapted their approach to meet PMA-level evidence requirements while minimizing delays.

Successful PMA Approval

Despite the early setbacks, the sponsor achieved full PMA approval. Key success factors included:

• Strong preclinical and clinical data
• Proactive FDA communication
• Expert guidance on CMC and labeling compliance

This section details the final submission process and how the team overcame regulatory hurdles to bring their product to market.

Why It Matters

As wound care technologies evolve—often integrating biologics, sensors, or drug-device combinations—regulatory flexibility and foresight are more important than ever.

This case study offers real-world insights into:

• FDA classification and reclassification processes
• Risk-based regulatory planning
• Clinical and preclinical evidence requirements for PMA
• Best practices for engaging with the FDA early and often

Who Should Read This

• Regulatory affairs professionals
• Clinical trial sponsors
• Wound care product developers
• Quality and compliance teams
• Biotech and medtech investors