MITA Comments on FDA’s Medical Device Accessories Draft Guidance

Dear Ms. Kux:

On behalf of the members of the Medical Imaging and Technology Alliance (MITA), we thank you for this opportunity to provide comments on FDA’s Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types, Draft Guidance. We are pleased the FDA continues to seek input for the development of strategies to promote appropriate regulation of device accessories, and define rational pathways to market. In a fast-paced technological world, regulatory frameworks must support the implementation of technologies for enhanced patient care. We believe this draft guidance is an appropriate first step by FDA to indicate an intention to reduce the regulatory burden on device accessories.

MITA is the leading organization and collective voice of medical imaging equipment, radiation therapy and radiopharmaceutical manufacturers, innovators and product developers. It represents companies whose sales comprise more than 90 percent of the global market for medical imaging technology. Advancements in medical imaging are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. The industry is extremely important to American healthcare and holds unique concerns marked by a continual drive for innovation and marketization cycles, complex technologies, and multifaceted supply chains—all with the goal of providing patients with safest, most advanced medical imaging currently available.

General Comments
MITA voices clear support for FDA’s position that “determining the risks of accessories according to their use with parent devices does not mean that all risks of a parent device are imputed to the accessory; the risk profile of an accessory can differ significantly from that of the parent device, warranting differences in regulatory classification.” We have consistently supported regulating accessories based upon the specific risk presented by the device when operating as an accessory with the intended parent device or devices. Industry would find it helpful, however, if the guidance included further detail on how FDA differentiates between a system “component” and an “accessory.”

Click here to read the full comment letter.