FDA Delays Implementation of Changes to “Intended Use”

On January 16, 2018, the FDA announced that the Agency will be delaying implementation of parts of its “intended use” rule due to concerns raised by the industry.

The FDA issued a Federal Register notice, attached here after the link, explaining that the delay of implementation would be “until further notice” and referenced a number of comments that the Agency received on the final rule that raise questions about the amendments to existing medical products “intended use” regulations.

The Agency also called for additional comments on the proposed rule to be made by February 5, 2018.