How are applications under § 35.1000 for new modalities, i.e., for presently unknown processes and materials, to be reviewed?
Each technology is to be evaluated on a case-by-case basis. This process is to include working with the ACMUI, the medical community, the public, and the developers of the new technology, as appropriate, to determine the specific risks associated with the technology and any additional regulatory requirements for the medical use of the technology. Refer to “Supplementary Information,” Section III, “Summary of Public Comments and Responses to Comments” for 10 CFR § 35.1000, as published in the Federal Register on April 24, 2002.
