Not sure of your predicate-equivalence argument?
Contact RQMIS at info@rqmis.com, call us at (978)-358-7307, or just click the Contact button below.
The traditional 510(k) is a primary vehicle for clearing a medical device for sale in the U.S. Key to getting clearance in the least amount of time is understanding and anticipating FDA concerns.
RQMIS replaced the
original consultants and investigated the root cause for the delay in
clearance, which was that the manufacturer was requesting clearance of a
neurosurgical product that included a new material – not present in
predicate devices -- that would be in contact with the brain and thus
subject to mechanical abrasion during normal use.
In addition, RQMIS determined that clearance delay had two additional causes:
To address the identified causes of the FDA clearance delay, RQMIS did the following:
RQMIS understood the
FDA’s concerns, and was able to justify the use of an animal study
rather than a clinical trial to demonstrate predicate equivalence – a
significant saving of time and money for the manufacturer. And in the
end, RQMIS was able to get clearance for this device in six months from initial engagement, including the execution of the animal study.
Not sure of your predicate-equivalence argument?
Contact RQMIS at info@rqmis.com, call us at (978)-358-7307, or just click the Contact button below.