Regulatory Open Forum

Hello Experts, 

I have a Class III IVD product that received its PMA approval. We have two pieces of equipment in our lab which our supplier is replacing with a new model. We plan to purchase the new model and validate. I believe this should be put on the annual report, not a 30-day notification, as we are not changing the manufacture processing and we are not affecting the S&E. We are purchasing the equipment from the same approved supplier who was on the original PMA. Would you agree this would be the correct approach? Thanks. 

Hello Anon,

That sounds about right, it would fall under the Annual Reporting.  Though it really depends on the new model of instrument/equipment what is exactly being changed.  If it is from the same company, new model does not impact the process, there is no impact to S&E, then probably Annual Reporting.  Of course, would need further detail to device type, processes by user, instruments/equipment used, but based on information probably a can confirm conclusion.

Hello Experts, 

I have a Class III IVD product that received its PMA approval. We have two pieces of equipment in our lab which our supplier is replacing with a new model. We plan to purchase the new model and validate. I believe this should be put on the annual report, not a 30-day notification, as we are not changing the manufacture processing and we are not affecting the S&E. We are purchasing the equipment from the same approved supplier who was on the original PMA. Would you agree this would be the correct approach? Thanks.