Last week the FDA released a notice for a workshop entitled “Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development,” to be held June 24 in Washington DC. The stated goal of the event is “to obtain public input on what are the most important unmet public health needs and what are the barriers to the development of medical devices that can cure, significantly improve, or prevent these illnesses and injuries”
From the release:
The workshop will focus on three topics: (1) Identification of the most important unmet public health needs; (2) delineation of the barriers to the development, redesign, and patient and healthcare professional access to medical devices that can cure, significantly improve, or prevent these illnesses or injuries; and (3) identification
of the actions the Federal Government can take to remove or minimize these barriers. The discussion of these general topics should not be limited by current statutes or regulations and will include, but not be limited to, discussion of the following questions:
1. Identifying areas of public health need:
a. Which unmet public health needs could be most effectively addressed by the development of new, or the redesign of existing, medical devices?
b. How should the Council set priorities amongst the identified public health needs? Are there specific factors that should be considered? If so, which and why?
2. Addressing barriers to development and/or redesign of medical devices:
a. What are the significant barriers facing innovators, academics, and/or industry that limit the availability and clinical use of medical devices that have the potential to improve public health?
b.How should any perceived or actual barriers be evaluated to determine whether federal intervention is appropriate?
c. How should federal agencies–including those present and others not represented–address those barriers that are out of proportion to what is warranted based on the public health needs?
Full release: Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development; Notice of Public Workshop; Request for Comments…
Workshop site and RSVP info: Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development