Regulatory Open Forum

Recently an IVD contract manufacturer requested in a specifications document for us to list ALL federal requirements related to the manufacture and sale of an IVD platform.  The "platform" consists of a consumable microarray, an imaging-detection-and reporting instrument, an off-the-self flatbed thermal cycler, and a reagent kit with all necessary components to conduct genetic testing on human patients.  I understand they want the normal regulations including:  registration with FDA as an IVD manufacturer, following 21CFR820, following FDA final guidance on 510(k) Substantial Equivalence Determination.  Can RAPS members help me fill in the blanks?  What other regulations are applicable to this kind of device besides what I already know about?

Thanks,

Michael Murphy

Hi Micheal,

I can't offer the total solution here, but i would like to share with you on product safety compliance required testing stadards which then will be part of the evidence for 510(K) / technical dossier in the future. The higher the classification of IVD, the higher the complexity of testing will be required.

In order to get your customer IVD in compliance, there are 3 main parts of it, instrument, testing assay and IVD system as a whole.

For Instruments, below are the standards that need to comply at minimum:

• Software validation, IEC 62304:2006
• Instruments electrical safety testing, IEC 61010-1, IEC 61010-2-081 and IEC 61010-2-101
• Instruments Electro-magnetic testing, IEC 61326-1 and IEC-2-6
• Instruments shock & vibration testing, ISTA 3A
• Instrument projected useful life
• Instrument system verification report
• FCC Compliance

For testing assays, below are the standards that need to comply at minimum:

• Open pouch stability study
• Closed pouch stability study, CLSI EP25-A

For IVD System as a whole:

• System accuracy & stability, IEC 13612
• System Precision, IEC 13612 & CLSI EP5-A2
• Repeatability & Reproduceibility, CLSI EP05-A3
• Linearity testing, CLSI EP-06-A
• Interference Substances Testing, CLSI EP07-A2, CLSI EP14-A3
• Human factory study, IEC 62366
• Transportation study, ISTA 3A

Hope above information helps!

Thank you!

Recently an IVD contract manufacturer requested in a specifications document for us to list ALL federal requirements related to the manufacture and sale of an IVD platform.  The "platform" consists of a consumable microarray, an imaging-detection-and reporting instrument, an off-the-self flatbed thermal cycler, and a reagent kit with all necessary components to conduct genetic testing on human patients.  I understand they want the normal regulations including:  registration with FDA as an IVD manufacturer, following 21CFR820, following FDA final guidance on 510(k) Substantial Equivalence Determination.  Can RAPS members help me fill in the blanks?  What other regulations are applicable to this kind of device besides what I already know about?

Thanks,

Michael Murphy