Oct 18, 2016
EMERGO SUMMARY OF KEY POINTS:
The Food and Drug Administration has issued new draft guidance based on International Medical Device Regulators Forum (IMDRF) proposals for clinical evaluation of software as a medical device.
The IMDRF proposed document, issued in August 2016, establishes clinical evaluation processes for software as a medical device, or SaMD, in order to determine safety, effectiveness and performance.
Although clinical evaluations are typically required for medical devices of all types, the IMDRF proposes additional clinical evaluation recommendations for SaMD given software’s unique characteristics such as indirect contact with patients and its operating in a “complex highly connected-interactive socio-technical environment” in which product modifications occur at a much faster rate than for more conventional devices.
Categories of SaMD determined by function
First, the IMDRF and FDA lay out three main categories or types of SaMD, explaining that the level and amount of clinical evaluation required of a particular SaMD depends largely on what type of function the product is designed to perform.
The three categories, listed in ascending order of significance in terms of whether and how the SaMD output affects healthcare decisions, are:
General principles for SaMD clinical evaluations
The IMDRF proposal ties clinical evaluation to a manufacturer or developer’s broader lifecycle management effort. Such evaluations should be planned prior to being conducted on a SaMD product, and incorporate appropriate risk assessment data and processes pertaining to that product.
“SaMD clinical evaluation includes the gathering and assessment of scientific validity, analytical validity and clinical (real-world, obtained from patients) performance of a SaMD,” states the guidance. “A combination of the results of these activities generates clinical evaluation evidence for a SaMD.”
How extensively a manufacturer or developer should conduct a clinical evaluation depends on several factors: the SaMD’s underlying algorithm, that algorithm’s degree of transparency, characteristics of the SaMD’s intended use target population and intended users.
Specific guidelines for SaMD clinical evaluation
The IMDRF also lists more specific recommendations for conducting SaMD clinical evaluations that can most effectively generate clinical evidence:
The FDA is seeking comment from industry on the draft guidance through mid-December 2016.
The International Medical Device Regulators Forum (IMDRF) has published new guidelines for how software developers whose products are considered medical devices may be affected by quality management system regulations that currently apply to more conventional device manufacturers.
The International Medical Device Regulators Forum (IMDRF), the successor organization to the Global Harmonization Task Force (GHTF), is seeking comment through August 2013 on proposed definitions of standalone medical device software. The IMDRF sees these definitions as a first step toward establishing an international framework for more uniform regulatory approaches to medical software.