Using FDA Guidance Documents to Properly Vet Third-Party Service Organizations

Thursday, April 17, 2:45-3:45 pm

Using relevant FDA guidance, by way of example, the remanufacturing versus servicing guidance, and the ultrasound 510(k) submission guidance to understand what questions HTMs should use when vetting potential third-party service providers. A focus will be on how to read the documents and how to apply that knowledge in creating a template that can be used with all medical devices. This approach is similar with what the IRS does with its “filing instructions” – they write, interpret and enforce.