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US FDA Finalizes Rule for Post-market Combination Product Safety Reporting


  • A new US FDA final rule addresses post-market safety reporting obligations for combination products.
  • Reporting requirements for combination products are determined by regulations that apply to their component drug, device and/or biological components.
  • A combination product’s component or constituent parts manufacturers must share post-market safety reporting data with each other, according to the new rule.

US FDA post-market safety reporting rule for combination productsFor the first time, a final rule issued by the US Food and Drug Administration establishes post-market safety reporting requirements specifically for combination products.

The final rule defines “combination product” as any product that includes the following components:

  • A drug and a medical device
  • A medical device and a biological product
  • A biological product and a drug
  • A drug, device and a biological product

The FDA’s previous approach to post-market oversight of combination products entailed regulations applicable to products’ component parts; for example, a drug/device combination product would be subject to safety reporting requirements for drugs and devices.

“These regulations for drugs, devices, and biological products share many similarities; however, each set of regulations has certain unique reporting requirements, standards and timeframes based in part on the characteristics of the type of product,” states the final rule. As such, variations and discrepancies between these requirements often caused inadequacies in post-market safety reporting for some combination products.

Components of the new final rule

The FDA’s new rule applies to both combination product manufacturers and makers of component or “constituent” parts of such products.

Companies must meet post-market safety reporting requirements for their combination products based on the types of US market authorizations they have obtained for their products. Thus, products holding new drug applications fall under drug safety reporting regulations, products with medical device premarket notification or approval applications must meet reporting requirements for medical devices, and products holding biologics license applications must meet reporting requirements set for biologics.

Beyond application-specific reporting requirements, the new rule also mandates reporting based on a combination product’s constituent parts:

  • Malfunction reports for device components
  • Field alert reports for drug components
  • Product deviation reports for biological components

“The final rule requires constituent part applicants to share certain postmarketing safety information they receive with one another,” the rule states.

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