Compliance Policy for Combination Product Postmarketing Safety Reporting; Immediately in Effect Guidance for Industry; Availability

The Food and Drug Administration (FDA or we) is announcing the availability of an update to the immediately in effect guidance for industry entitled "Compliance Policy for Combination Product Postmarketing Safety Reporting." This guidance describes FDA's compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety reporting. FDA is updating this guidance by extending the period of time during which FDA does not intend to enforce certain combination product postmarketing safety reporting requirements.