FDAnews Device Daily Bulletin

Industry Groups Question the FDA Approach to Software as a Medical Device

Jan. 30, 2017

Draft guidance circulated by the FDA on software as a medical device (SaMD) might not fit well into the agency’s regulatory regime, according to written comments submitted by two industry groups.

The FDA released the draft guidance on SaMD — which was prepared by the International Medical Device Regulators Forum (IMDRF) — for public comment Oct. 14, 2016. The document outlines steps required to generate clinical evidence of effectiveness and safety of SaMD products. The agency had logged 58 comments on the draft.

AdvaMed said the draft guidance uses some terms that have particular meanings in the EU or that are specific to FDA regulations, and which do not necessarily translate across jurisdictions. For example, the term “clinical evaluation” is usually associated in the EU with a clinical evaluation report prepared to support marketing of a product — but not in the U.S. Use of the term would cause confusion and could lead other regulatory authorities to implement documentation requirements that are not intended, the group said. — Jeff Kinney

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