FDA ISSUES Q&A GUIDANCE ON HDE REGULATION
The FDA has posted an updated guidance answering common questions about humanitarian use devices (HUDs) and applications for humanitarian device exemptions (HDEs).
The document updates a previous 2001 guidance and reflects comments received by the agency. It also clarifies postmarket procedures related to HDE regulation, the FDA said.
An HDE application is similar to a premarket approval application, but is exempt from certain effectiveness requirements, the guidance says. FDA approval of an HDE allows a firm to market an HUD, defined as a "medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year."
The guidance covers where requests for HUD designation should be submitted, requirements for HUD designation and what the FDA considers a "comparable device." The document also discusses how firms should verify that the amount charged for a device does not exceed the costs of R&D, manufacturing and distribution.
Furthermore, the guidance clarifies the extent to which the quality system regulation (QSR) applies to HDEs and whether firms can request an exemption from the QSR.