510(k) FDA Submission Repair

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:

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

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

• Recommended the conduct of an animal pre-clinical study to demonstrate that the performance of the subject device was equivalent to the predicate medical device.
• Worked with the manufacturer’s Chief Technology Officer to draft an appropriate medical device pre-clinical protocol
• Submitted a Pre-submission requesting a teleconference with the FDA
• Conducted the teleconference with the FDA where the animal pre-clinical study proposal and clinical protocol were approved
• Assembled and submitted an additional 510(k) FDA 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 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.

US FDA 510(k) Consulting for Medical Devices and IVDs

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.