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:
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