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,
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,