garthbrooks
Established Member
- Reaction score
- 0
As we have disclosed in previous postings we have submitted our clinical data and made a formal submission to the FDA earlier this year. This review is not an easy or quick process. Many FDA submissions take years to receive a final judgment. To date we have found FDA staff and their comments to be very professional and meticulous. They will not approve or clear a device without in-depth scrutiny of its safety, efficacies, manufactured materials, instructional manuals and promotional material. For a product such as the HairMax LaserComb with indications and claims that have no precedence there is an additional task of setting criterion and regulation. So far we have had 2 formal reviews and cleared a many of initial hurdles, we are just now refining our manuals and promotional material along with filing additional regulatory documentation.
We do maintain great confidence in our clinical data & submission and are encouraged by their comments to date. We do hope that we will soon hear back with a favorable judgment. Please appreciate that this is a time consuming undertaking and please be patient while we fulfill all our requirements.
Regards,
David Michaels,
Managing Director
We do maintain great confidence in our clinical data & submission and are encouraged by their comments to date. We do hope that we will soon hear back with a favorable judgment. Please appreciate that this is a time consuming undertaking and please be patient while we fulfill all our requirements.
Regards,
David Michaels,
Managing Director