Kuldeep Singh
Involved In Discussions
Hi Everyone,
We are manufacturer of X-Ray Medical device which falls under Class II FDA regulations. We are new to 510(K) submission and almost compile all the necessary data for 510(K) traditional except External lab test reports (like IEC 60601 & IEC 60601-1-2).
As we know it takes almost 180 days for review. So, is there any other way to submit the file without External lab test reports (e.g IEC 60601-1 & IEC 60601-1-2) and once we receive the reports then these shall be submitted to FDA (Actually Testing is already done but labs are unable to proceed for test reports due to their external audits). It is just to avoid the delay in getting 510(K) for our product.
Thanks in advance.
We are manufacturer of X-Ray Medical device which falls under Class II FDA regulations. We are new to 510(K) submission and almost compile all the necessary data for 510(K) traditional except External lab test reports (like IEC 60601 & IEC 60601-1-2).
As we know it takes almost 180 days for review. So, is there any other way to submit the file without External lab test reports (e.g IEC 60601-1 & IEC 60601-1-2) and once we receive the reports then these shall be submitted to FDA (Actually Testing is already done but labs are unable to proceed for test reports due to their external audits). It is just to avoid the delay in getting 510(K) for our product.
Thanks in advance.