Hi
I seek clarification on establishment registration and appropriate QSR controls for OEM Suppliers.
Case 1): Company A owns the design of product(P1); company B manufactures P1 and packs and sends to A. This P1 is the finished good that is an accessory to an IVD medical device P.
P+P1 form as a system and will be sold to customers.
Case 2): Company A owns the product system (P+P1)-legal manufacturer; Company B owns the design and also manufactures P1 and packs and sends to A. This P1 is the finished good that is an accessory to an IVD medical device P.
For both cases 1) and 2), for the below options what are the Establishment registration and OEM supplier applicable QSR controls:
i) P is a class II IVD device; then if we submit a 510(k), it will be for P&P1, where P1 also falls under Class II and B need to implement the QSR Controls similar to that level of P - in the sense, fully comply with 21 CFR 820 - is this correct?
So in this case, does B has to register with FDA and need to fully comply with 21CFR 820?
ii) P1 is an accessory (not re-orderable), and labeled as "General Purpose Laboratory Equipment", then does B
- requires registration with FDA?
- need to comply fully or partially with 21 CFR 820?
iii) if P1 is customer reorderable (consumable), and if A labels it with an IVD symbol in it, then does B
- need to register with FDA?
- need to comply fully with 21 CFR 820 or only with complaint files and quality records?
iv) if P1 is customer reorderable and labeled as "General Purpose Reagent" or "General Purpose Laboratory Equipment" then, does B
- requires registration with US FDA?
- need to comply fully with 21 CFR 820 or only to 820.198 complaint files and 820.180 records?
For 4 options, the 510(k) will be submitted for P that includes P1 as well. No intend to submit a separate 510(k) for P1.
The other thing is if we don;t have a separate 510(k) for P1, then can it be sold as reorderable accessory/consumable?
Thanks,
Sreenu
I seek clarification on establishment registration and appropriate QSR controls for OEM Suppliers.
Case 1): Company A owns the design of product(P1); company B manufactures P1 and packs and sends to A. This P1 is the finished good that is an accessory to an IVD medical device P.
P+P1 form as a system and will be sold to customers.
Case 2): Company A owns the product system (P+P1)-legal manufacturer; Company B owns the design and also manufactures P1 and packs and sends to A. This P1 is the finished good that is an accessory to an IVD medical device P.
For both cases 1) and 2), for the below options what are the Establishment registration and OEM supplier applicable QSR controls:
i) P is a class II IVD device; then if we submit a 510(k), it will be for P&P1, where P1 also falls under Class II and B need to implement the QSR Controls similar to that level of P - in the sense, fully comply with 21 CFR 820 - is this correct?
So in this case, does B has to register with FDA and need to fully comply with 21CFR 820?
ii) P1 is an accessory (not re-orderable), and labeled as "General Purpose Laboratory Equipment", then does B
- requires registration with FDA?
- need to comply fully or partially with 21 CFR 820?
iii) if P1 is customer reorderable (consumable), and if A labels it with an IVD symbol in it, then does B
- need to register with FDA?
- need to comply fully with 21 CFR 820 or only with complaint files and quality records?
iv) if P1 is customer reorderable and labeled as "General Purpose Reagent" or "General Purpose Laboratory Equipment" then, does B
- requires registration with US FDA?
- need to comply fully with 21 CFR 820 or only to 820.198 complaint files and 820.180 records?
For 4 options, the 510(k) will be submitted for P that includes P1 as well. No intend to submit a separate 510(k) for P1.
The other thing is if we don;t have a separate 510(k) for P1, then can it be sold as reorderable accessory/consumable?
Thanks,
Sreenu