The U.S. Food and Drug Administration (FDA) has issued its final guidance on the remanufacturing of medical devices.

This guidance aims to clarify the distinction between servicing and remanufacturing, emphasizing that remanufacturers, including those who did not originally manufacture the device, are subject to the same regulatory requirements and inspections as original equipment manufacturers (OEMs).

Key points include:

1. Definition Clarity: Servicing involves repair and maintenance to restore a device to its original use, whereas remanufacturing significantly alters a device’s performance or safety specifications beyond its original intended use.
2. Regulatory Requirements: Remanufacturers must register independently of OEMs, obtain marketing authorization, have a quality system, and comply with medical device reporting requirements.
3. Industry Concerns: Industry stakeholders have raised issues about the complexity of the guidance for third-party servicers, the need for OEMs to provide necessary information for remanufacturing, and the challenges posed by cybersecurity and trade secret protections.

The guidance aims to ensure patient access to high-quality, safe, and effective medical devices by providing clear regulatory expectations and addressing industry feedback.