Healthcare, Industry News, Medical Devices, Regulatory Affairs

US FDA issues a new rule that addresses post-market safety reporting obligations for combination products

USFDA has issued a final rule establishing the post-market safety reporting requirements specifically for combination products.

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.

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

Manufacturers 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.

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 post-marketing safety information they receive with one another.

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