Differences between Standards, Recognized consensus standards, and Guidance
| Standards | Recognized consensus standards |
Guidance |
| A standard is a repeatable, harmonized, agreed, and documented way of doing something. | It is a database that provides the most up-to-date list of voluntary consensus standards to which the FDA will accept a Declaration of Conformity. | 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. |
| Standards contain technical specifications or other precise criteria designed to be used consistently as a rule, guideline, or definition. | FDA-recognized consensus standards are standards that FDA has vetted and determined are appropriate to support the clearance or approval of a device. | Guidance documents include but are not limited to, documents that relate to:
· the design, production, labeling, promotion, manufacturing, and testing of regulated products · the processing, content, and evaluation or approval of submissions · inspection and enforcement policies they they |
| They help to make life simpler and increase the reliability and the effectiveness of many of the goods and services we use | The purpose of the FDA’s formal recognition of consensus standards is to streamline the premarket review process for medical devices. | They are intended to provide helpful information to the public, such as clarifying obligations under existing law or regulation or providing information on agency procedures. |
| Standards result from collective work by experts in a field and provide a consensus at the time when the standards are developed. | It consists of those national and international standards recognized by the FDA which manufacturers can declare conformity and is part of the information the Center can use to make an appropriate decision regarding the clearance or approval of a submission. | Guidance documents are documents prepared for FDA staff, regulated industry, and the public that describe the agency’s interpretation of or policy on a regulatory issue. |
