Get EA Final Guidance

Guidance documents do not establish legally enforceable rights or responsibilities. They do not legally bind the public or FDA.

Guidance documents represent FDA's current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public.

A guidance document is an agency statement of general applicability and future effect, other than a regulatory action, that sets forth a policy on a statutory, regulatory, or technical issue, or an interpretation of a statute or regulation.

FDA regulations can be found in Title 21 of the Code of Federal Regulations (CFR). FDA follows the procedures required by its "Good Guidance Practice" regulation to issue FDA guidance. FDA guidance describes the agency's current thinking on a regulatory issue. Guidance is not legally binding on the public or FDA.

If the EA concludes that no significant impacts will occur, a Finding of No Significant Impact (FONSI) is prepared.

A federal agency can determine that a Categorical Exclusion (CATEX) does not apply to a proposed action. The federal agency may then prepare an Environmental Assessment (EA). The EA determines whether or not a federal action has the potential to cause significant environmental effects.

General to Specific A change from a general to a specific indication for use is defined as: Any proposed increase in the level of specificity of the indication for use of a medical device.

An EA is to determine whether a specific threshold is crossed – the threshold of "significant" impact. An EIS simply has to reveal the impacts, not demonstrate that a threshold is or is not crossed.