Michael Cejnar - Comment

As a medical specialist cardiologist, the definition of paediatric as 0-21 years may have some legal basis, but medically seems bizarre and nonsensical. To me it seems like it will defeat any intent of this rule. The legal precedent for the 21 year definition relating to Paediatric exemptions was extremely generous with the age up to 21 years - as it did no harm and probably usefully covered some congenital disorders (like cardiac ones) which required follow up surgery and treatment into the 20's. However, a 21 year old can get almost all diseases that an 'adult ' gets, so your rule may be expected to cause the notification from almost all medical devices on the market, except for those with intended use restricted to geriatric patients like perhaps adult incontinence pads or Zimmer frames. If there is some valid medical reason behind this age limit, it would be most useful to feature that reason prominently in the rule.