Differences in post market safety reporting for Combination Product Applicants

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#1
We are device manufacturer, and we are working with a pharma company that holds a BLA. The pharma company has approached us to manufacture a new reconstitution device for the biologic product. Currently, the biologic uses a device component that is tied to the original BLA. The proposed device would be cleared through CDRH for a generic intended use, not tied specifically to a specific biologic or BLA.

What are the differences in post market safety reporting for Combination Product Applicants based on whether they include a general 510k device vs a drug specific device (i.e. the device company as a Constituent Part Applicant)?


Thanks,
 
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#2
Will the device be co-packaged with the drug? If yes, there will be no difference to the current situation. The PharmaCo is also in the new scenario the Combination Product Applicant for the device, as per 21 CFR Part 4 Subpart 4.
Guidance is provided in the Final Guidance "Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff". Please see the example in Section III. A. "Who Is Subject to the Combination Product PMSR Final Rule?":

A company is a Constituent Part Applicant only if that entity holds an application to market that product as a constituent part of a combination product. For example, SyringeCo holds a 510(k) for a general-use syringe for injection and markets empty syringes under this 510(k). PharmaCo purchases syringes from SyringeCo and includes them with drug product vials in a co-packaged combination product for which PharmaCo holds the approved NDA. Because SyringeCo does not hold an application under which the syringe is marketed as a constituent part of a combination product, SyringeCo is not a Constituent Part Applicant for a combination product. Rather, PharmaCo is the Combination Product Applicant for the co-packaged combination product, and there are no Constituent Part Applicants for the combination product.
That said, PharmaCo has to fulfill reporting requirements as nicely summarized in Appendix 1 of the Guidance (see line BLA, Biologic-Device CP).
 
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