Regulatory Open Forum

Dear friends

hope you can assist me with the following question, or reffer me to someone who can:

To my best understanding, in order to CLIA register a lab out of US we need to enter a process with waiting list prior to having the registration number (which is not the case for US based labs). Maybe you know how long such waiting can take? I am trying to estimate the registration process timeline- how long will it take us from registration process initiation to obtaining the registration number?

Thank you!

Any thoughts? :)