Do you need a 510k medical device FDA submissions expert?
Contact RQMIS at info@rqmis.com, call us at (978)-358-7307, or just click the Contact button below. We can provide you 510k FDA medical device consulting services!
The traditional 510(k) FDA clearance 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 medical 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 FDA clearance for this device in six months from initial engagement, including the execution of the animal study. The repair of the 510k presentation was successful.
One of the first steps toward marketing an FDA Class II medical device or IVD in the United States is to file a Premarket Notification with the FDA, also known as an FDA 510(k) submission or FDA DeNovo. Technically, the FDA does not "approve" medical devices or IVDs for sale under the 510(k) process; the agency gives "clearance" for them to be sold in the U.S. Our FDA expert consultants understand this and use the terms "FDA approval" and "FDA clearance" interchangeably.
Do you need a 510k medical device FDA submissions expert?
Contact RQMIS at info@rqmis.com, call us at (978)-358-7307, or just click the Contact button below. We can provide you 510k FDA medical device consulting services!