FDA Proposes to Define Certain Device Accessories as Class I

The FDA issued a list of medical device accessories that it believes are safe and effective enough to be categorized as Class I and requested public feedback on the proposed list.

Class I devices are subject to the least amount of control because the agency believes their use presents a “low to moderate risk.”

The accessories the agency has proposed to be considered distinct from other devices and classified into Class I are:

• Gastroenterology-urology accessories to a biopsy instrument;
• Penile implant surgical accessories;
• Ureteral stent accessories;
• Biliary stent, drain and dilator accessories;
• Suprapubic catheter accessories;
• Implanted mechanical/hydraulic urinary contingence device surgical accessories;
• An air-handling apparatus accessory; and
• A corneal inlay inserter handle.

The FDA said it has not made a final determination for the suggested accessories and called for comment on the list.

Read the notice here: www.fdanews.com/08-16-18-ClassI.pdf. — James Miessler