On December 20, 2016, the Food and Drug Administration (FDA) published regulations (Final Rule) establishing postmarketing safety requirements for combination products, which are products comprised of:

(1) a drug and a device;

(2) a device and a biological product;

(3) a biological product and a drug; or

(4) a drug, a device, and a biological product.

“Postmarketing safety” involves manufacturing events, device malfunctions, and events causing injury to users, and the reporting requirements relating to product and patient safety arising from these events. 

  • Under the Final Rule, both “combination product applicants” and “constituent part applicants” must comply with postmarketing safety reporting requirements applicable to the product based on the application type (e.g., new drug application, premarket approval application, biologics license application).
  • Combination product applicants must submit additional specified reports based on the constituent parts included in the combination product (e.g., malfunction reports if the combination product includes a device, field alert reports if it includes a drug, and biological product deviation reports if it includes a biological product).
  • Constituent part applicants also have to share postmarketing safety information they receive with one another.
  • The Final Rule outlines how applicants must submit postmarketing safety reporting information to the FDA and what records they must maintain.
  • Among other things the FDA: (1) clarified that the final rule applies only to combination product and constituent part applicants; (2) explained when a single report suffices to comply with more than one reporting requirement; and (3) incorporated biological product deviation reporting and device correction and removal reporting requirements applicable to combination product applicants.

Prior to this, the FDA had applied the provisions relating to the constituent parts.