CPC comments on FDA’s Draft Guidance on Safety Considerations for Product Design to Minimize Medication Errors

The CPC’s comments addressed three issues related to three issues:

• The failure of the draft guidance to spell out the roles and responsibilities of the various offices with jurisdictional oversight of combination products with respect to human factors issues.
• The lack of clarity regarding whether existing human factors guidance documents would be relied on by DMEPA.
• Whether DMEPA would defer to CDRH with respect to human factors as it relates to the device function of a drug-device combination product.