US FDA Discloses Guidance on SaMD for Consultation

US regulatory authority Food and Drug Administration (FDA) on 13th October 2016, opened a public a consultation on a harmonized guidance on the clinical evaluation of software as a medical device (SaMD) formulated by the International Medical Device Regulators Forum (IMDRF).

Proposed Guidance

According to IMDRF, the goal of the guidance is “to establish a common and incorporated understanding of clinical assessment and principles for demonstrating the safety, effectiveness and performance of SaMD.”

Particularly, the guidance providing recommendations for device manufacturers on methods of clinical evaluation and the level of clinical evidence necessary to support the use of a SaMD depending on previosuly finalized IMDRF guidance on risk categorization for SaMD, and lays out when SaMD  should undergo an independent review.

“Based on the significant impact SaMD has on clinical outcomes and patient care, a SaMD manufacturer is supposed to collect, analyze, and evaluate data, and develop evidence to establish  the assurance of safety, effectiveness and performance of the SaMD,” the guidance claims.

However, the guidance states that the recommendations made  within are not intended to substitute or conflict with pre-market or post-market regulatory requirements related to the regulatory classification of SaMD in various jurisdictions,” and notes that -the recommendation for independent review for various categories of SaMD does not imply the need  for premarket review (authorization) by a regulatory agency.”

Public Consultation

The proposed guidance was endorsed by the IMDRF management committee following a presentation by Bakul Patel, associate center director for digital health at FDA’s Center for Devices and Radiological Health (CDRH) and IMDRF SaMD working group chair at a conference in Brazil September 2016.

Now, FDA and IMDRF are asking stakeholders to comment on the guidance prior to submission of a final version to the IMDRF management committee in February.

In specific, FDA and IMDRF are asking for comment on eight aspects of the guidance:

  • Does the document address the intention captured in the introduction/scope or viceversa?
  • Does the document properly translate and apply current clinical vocabulary for SaMD?
  • Are there other kinds of SaMD beyond those intended for non-diagnostic, diagnostic and therapeutic purposes that should be highlighted/considered in the document?
  • Does the document adequately address the relevant clinical evaluation methods and procedures for SaMD to generate clinical evidence?
  • Are there other appropriate methods for generating clinical evaluation evidence that are relevant for SaMD beyond those described in the document?
  • 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?
  • Are there recommendations identified in section 7.3 related to the “importance of independent review” appropriate as outlined for the different SaMD categories?
  • Given the uniqueness of SaMD and the proposed framework—is there any effect on currently regulated devices or any possible adverse consequnces?”

Federal Register notice, Draft Guidance