The U.S. Food and Drug Administration (FDA) has issued a Final Rule that establishes post-market safety reporting requirements for so-called combination products.
According to the FDA, a combination product is one that combines two or more different types of regulated medical products, such as drugs, devices or biological products. Typical combinations could include:
- A drug and biological product
- A medical device and drug
- A biological product and medical device
- A biological product, drug, and medical device
Previously, FDA post-market reporting requirements were applicable solely to products’ component parts. The new regulations have unique reporting requirements, standards, and timeframes. Additionally, the new standards are based on the specific characteristics of each type of product.
The FDA says that these additional post market safety reporting requirements can be expected to reduce the number of malfunctions and recalls in combination medical products.