The U.S. Food and Drug Administration (FDA) has released its final guidance on the remanufacturing of medical devices, providing clarity on regulatory requirements for remanufacturers. The guidance emphasizes the distinction between servicing and remanufacturing, defining later as activities that significantly alter a device's performance or safety specifications beyond its original intended use. Remanufacturers are now subject to investigations and inspections by the FDA, ensuring compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations.
FDA Director Jeff Shuren stated that the guidance aims to maintain patient access to high-quality, safe, and effective medical devices while removing barriers to device repair and maintenance. The agency's engagement with industry and the public since 2016 led to the publication of this guidance, addressing concerns raised by stakeholders regarding regulatory oversight, terminology, and enforcement. Remanufacturers are now required to comply with premarketing requirements, have their own device listing and establishment registration, and adhere to quality system regulations. The FDA encourages OEMs to provide servicing instructions facilitating routine maintenance and repair of reusable devices, promoting public health while respecting trade secrets and confidential information.
