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GUIDANCE DOCUMENT

Software as a Medical Device (SAMD): Clinical Evaluation Guidance for Industry and Food and Drug Administration Staff December 2017

Final
Docket Number:
FDA-2016-D-2483
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Devices and Radiological Health

IMDRF is a voluntary group of medical device regulators from around the world who have come together to accelerate international medical device regulatory harmonization and convergence. The IMDRF Management Committee (IMDRF MC) chartered the SaMD Working Group (WG) to develop a regulatory framework for SaMD and to develop converged principles for global regulators to adopt in their respective jurisdictions. This IMDRF document has been unanimously approved by the IMDRF MC. For more information on IMDRF activities, please see http://www.imdrf.org/index.asp.

This guidance adopts the internationally converged principles agreed upon by the IMDRF. FDA adoption of these principles provides FDA with an initial framework when further developing FDA’s specific regulatory approaches and expectations for regulatory oversight. This guidance does not provide recommendations for FDA Staff and Industry to apply to specific regulatory situations, nor does it modify current regulatory expectations, including those for regulatory submissions, at this time. The words require or requirements used in this document do not reflect FDA regulatory requirements and are intended only to be considerations for Industry and FDA staff. FDA intends to consider the principles of this guidance in the development of regulatory approaches for SaMD and digital health technologies. In developing regulatory approaches based on the principles of this guidance, the agency intends to follow a public process, including providing opportunities for public input. For more information on FDA adoption of IMDRF documents as an FDA guidance document, please see International Medical Device Regulators Forum (IMDRF).


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All written comments should be identified with this document's docket number: FDA-2016-D-2483.