Case study: FDA 510(k) NSE Decision is Remediated
Michael Wienholt
Michael Wienholt

IVD Research, Inc.


The client - a manufacturer of in vitro diagnostic medical devices - contacted me in a state of frustration after having received a "Not Substantially Equivalent (NSE)" letter from FDA for a 510(k) submission for the company's test for Giardia. The client was eager to market the test and realize revenue growth for the business.


I reviewed the original 510(k) submission and the complete FDA correspondence and determined that an important reproducibility study was lacking in the original submission. I worked with the manufacturer's clinical collaborator to design a new study. I worked with the FDA Lead Reviewer in the Division of Microbiology Devices to resolve the other deficiencies noted by FDA in the NSE Letter.


The new 510(k) was submitted to FDA, resulting in market clearance for the test less than 8 months after the original submission was rejected.