FDA Releases Draft Guidance on Software as a Medical Device (SaMD): Clinical Evaluation

  • By: Staff Editor
  • Date: October 25, 2016
  • Source:
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FDA Releases Draft Guidance on Software as a Medical Device (SaMD): Clinical Evaluation

The US FDA has released the draft guidance on the clinical evaluation of software as a medical device (SaMD) prepared by the International Medical Device Regulators Forum (IMDRF). The Draft Guidance describes standards for determining the clinical validity by demonstrating the analytical validity, the scientific validity and clinical performance of the SaMD.

The guidance states, "Based on the significant impact SaMD has on clinical outcomes and patient care, a SaMD manufacturer is expected to gather, analyze, and evaluate data, and develop evidence to demonstrate the assurance of safety, effectiveness and performance of the SaMD."

However the guidance does not addresses:

  • Other types of software used in health care for retrieving information from devices or systems, organizing the collected data, or optimizing healthcare workflow by automating healthcare provider’s care protocols.
  • The regulatory classification of SaMD and whether a premarket clearance is required for a specific SaMD.
  • Issues that are generic to all medical devices or specific to a country or jurisdiction such as Off-label use or foreseeable misuse; device classification of specific SaMD; and whether a pre-market approval or certification is required for specific SaMD.

Comment Period

FDA has announced the comment period on draft guidance is open and will accept the comments till December 13, 2016 before submitting the final guidance in February, 2017. To post your comment, go to docket number FDA-2016-D-2483 at and click Comment Now.

FDA is requesting for the comment on the following eight aspects of the guidance:

  1. Does the document address the intention captured in the introduction/scope or vice versa?
  2. Does the document appropriately translate and apply current clinical vocabulary for SaMD?
  3. Does the document adequately address the relevant clinical evaluation methods and processes for SaMD to generate clinical evidence?
  4. Are there other types of SaMD beyond those intended for non-diagnostic, diagnostic and therapeutic purposes that should be highlighted/considered in the document?
  5. Are there other appropriate methods for generating clinical evaluation evidence that are relevant for SaMD beyond those described in the document?
  6. Are the recommendations identified in section 7.2 related to the “importance of clinical evidence and expectations” appropriate as outlined for the different SaMD categories?
  7. Are the recommendations identified in section 7.3 related to the “importance of independent review” appropriate as outlined for the different SaMD categories?
  8. Given the uniqueness of SaMD and the proposed framework–is there any impact on currently regulated devices or any possible adverse consequences?

Related Training:

FDA's Medical Device Software Regulation

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