510(k) Submission Repair

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:

• The original 510(k) was poorly written leading to misunderstanding
• The new material in the device design had not been subject to adequate performance testing to demonstrate equivalence to the predicate device

To address the identified causes of the FDA clearance delay, RQMIS did the following:

• Recommended the conduct of an animal study to demonstrate that the performance of the subject device was equivalent to the predicate device.
• Worked with the manufacturer’s Chief Technology Officer to draft an appropriate protocol
• Submitted a Pre-submission requesting a teleconference with the FDA
• Conducted the teleconference where the animal study proposal and protocol were approved
• Assembled and submitted an additional 510(k) response based on agreements reached with the FDA. The response was reviewed by a Technical Writer to assure the consistency and clarity of the response

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.