What is the primary focus of 21 CFR 814 Subpart H?

The primary focus of 21 CFR 814 Subpart H is specifically on Humanitarian Use Devices (HUDs). This regulation outlines the framework for the development and approval of devices intended to treat or diagnose conditions that affect fewer than 8,000 individuals in the United States per year. The intent of Subpart H is to facilitate patient access to these medical devices that address rare diseases or conditions, thereby balancing the need for prompt access with the requirement for safety and effectiveness.

Under this regulation, sponsors can seek a Humanitarian Device Exemption (HDE) to allow for the marketing of HUDs without the same level of evidence typically necessary for standard device approvals. The focus on HUDs emphasizes the need to ensure that patients with rare diseases have access to potentially beneficial devices while still maintaining safety standards.

Other areas mentioned, like market authorization for devices, patient enrollment processes, and quality assurance, are relevant to the broader scope of medical device regulation but do not specifically address the unique considerations and procedures set forth for HUDs in Subpart H. This focus on rare conditions and the special exemption process distinguishes Subpart H from the general device approval pathways covered in other parts of the regulations.