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The FDA proposes to amend the combination product regulation

Michael Malis

Quite Involved in Discussions
In general, we will still be required to comply with the requirements for postmarket safety reporting associated with the application used to approve or clear their combination product, as long as the [applicable] five unique specified provisions particular to each different set of regulations are, in fact, complied with by the reporter.

These unique provisions are as follows:
[1] 5-day Reports for devices (803.53(a)) - applicable to device constituent part(s) of a combination product,
[2] 30-Day Device Malfunction Reports (803.20(b)(3)(ii)), applicable to device constituent part(s) of a combination product,
[3] 15-Day "Alert Reports" for Drugs and Biological Products (314.80(c)(1) and (e), and 600.80(c)(1) and (e)), applicable to Drug and/or Biological constituent part(s) of a combination product,
[4] 3-Day Field Alert Reports for Drugs (314.81(b)(1)), applicable to drug constituent part(s) of a combination product, and
[5] Expedited Blood Fatality Reports (606.170), applicable to combination products with blood and blood-component constituent parts.

In cases where two types of reports would be required for the same incident (e.g. 15-day Alert Report for drug and 30-day Device Malfunction report), the report with the shortest timeframe must be submitted.
That single report will also meet the requirements of the latter report. *** FDA does not expect or desire that reporters submit duplicate reports, and this proposal is intended to ensure that duplicative reporting does not occur. ***

For combination products cleared under one marketing application, the lead Center is responsible for reviewing all postmarketing safety reports for the combination product, regardless of which constituent part is associated with the event.

For combination products cleared under two marketing applications, postmarket safety reporting requirements for each constituent part apply and need to be reported to the Center that cleared/approved the constituent part. When a combination product is approved/cleared under multiple marketing applications held by different sponsors, each sponsor is required to submit all information about postmarketing safety incidents regarding the combination product to the other sponsor within 5 calendar days.
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