The final rule clarifies but does not change FDA’s interpretation and application of existing intended use regulations for medical products. The benefits of this rule are additional clarity and certainty for manufacturers and stakeholders regarding evidence that is relevant in evaluating whether an article is intended for use as a drug or device. This final rule is not expected to impose any significant additional costs on firms.
Regulatory Impact Analysis
Regulations Regarding "Intended Uses" (Final Rule) (PDF- 140KB)
Docket: FDA- 2015-N-2002
Federal Register: 86 FR 41383, August 2, 2021