Apr 25, 2011
The US Food and Drug Administration’s Office of Combination Products (OCP) has updated its guidance on Request for Designation (RFD) documents submitted by manufacturers or their sponsors in order to determine how to classify their devices.
The revised guidance spells out more clearly what information the OCP requires within an RFD in order to more promptly determine whether a product should be regulated as a drug, device, biological product or combination product.
The OCP recommends that manufacturers submitting RDFs make especially sure to include the following information:
- Complete description of product and its composition
- Clear description of product’s intended use or indications
- Product’s mode of action
- Product’s primary mode of action (PMOA)
- Explanation of the basis of PMOA determination—any literature, evidence or testing results supporting the PMOA you ascribe to your product
- Assignment algorithm—how you think your product should be classified, and why
The revised guidance was prompted by changes to US federal regulation 21 CFR Part 3 involving the definition of PMOA.
Author
- Stewart Eisenhart