marmotte
Diapason Consulting
Dear all,
I am advising a friend who's marketing a nasal aspirator. This is a "basic" one, where the user sucks on a small tube hoping not to swallow the patient's nasal material
I found a post already related to this issue - MDD-wise a nasal aspirator seems to be a medical device.http://www.elsmar.com/Forums/showthread.php?t=36554&highlight=nasal+aspirator
I am interested though at this stage at the US/FDA definition.
I am not sure what regulation actually covers it.
Under the ENT rule - which is the first to come to mind - there is nothing appropriate.It seems like only powered devices are even classified!
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=874
880.6740 Vacuum-powered body fluid suction apparatus is my next bet...but
WTF classII? Hospital panel ? Special control --- Sounds to me like the “vacuum” means “vacuum from a powered source”.
Any other idea?
I think there may be a case to justify that it is NOT EVEN a medical device, as it does not intend to treat the disease, but alleviate the discomfort of some of the symptoms (i.e. runny nose)
I am advising a friend who's marketing a nasal aspirator. This is a "basic" one, where the user sucks on a small tube hoping not to swallow the patient's nasal material
I found a post already related to this issue - MDD-wise a nasal aspirator seems to be a medical device.http://www.elsmar.com/Forums/showthread.php?t=36554&highlight=nasal+aspirator
I am interested though at this stage at the US/FDA definition.
I am not sure what regulation actually covers it.
Under the ENT rule - which is the first to come to mind - there is nothing appropriate.It seems like only powered devices are even classified!
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=874
880.6740 Vacuum-powered body fluid suction apparatus is my next bet...but
WTF classII? Hospital panel ? Special control --- Sounds to me like the “vacuum” means “vacuum from a powered source”.
Any other idea?
I think there may be a case to justify that it is NOT EVEN a medical device, as it does not intend to treat the disease, but alleviate the discomfort of some of the symptoms (i.e. runny nose)