Software as a Medical Device (SaMD): Possible Framework for Risk Categorization and Corresponding Considerations Proposed Final IMDRF WG(PF)/N12 R10 Bakul Patel, IMDRF WG Chair
Goals • International convergence and common understanding of Software as a Medical Device (SaMD): – Generic types of SaMD – Generic risks of SaMD that affect public health – Expectations of controls required to minimize generic risk • Establish a framework for regulators to incorporate converged controls into their regulatory paths or classifications. 8/15/14 2
Final Timeline 8/15/14 3
Combined effort for N12/R10 Phase III Phase I Phase II • SaMD Key definitions • What factors of SaMD • What are the affect public health risk? controls/expectations • What generic types of SaMD exists? • What are the generic risks for the types of SaMD? Informal input from SaMD Framework stakeholders IMDRF/N12/PD1-R5 Public Consultation Final: 12/2013 Proposed Final: 8/2014 IMDRF/N10/R2 IMDRF WG (PF)/N12/R10 4 8/15/14
Public feedback towards PD Public Key Themes Feedback Scope: • 2 month public commenting • Who is Intended audience (regulators, period (April/May 2014) industry • 700+ comments • What is in/out of scope (classification) Framework: • Reviews and Q&A sessions with • Define terms & concepts unique to SaMD: regulators, trade associations Definition statement Regulators (Canada, FDA, EU, Health Conditions (context of use) Japan) Medical purpose of information Industry (AdvaMed, CDS (treat/diagnose, drive, inform) Coalition, DITTA, Eucomed, • Align SaMD Types logic ITAC / COACH, JIRA, Medec) • Expand/clarify examples Controls: Recommend general and special considerations for SaMD 8/15/14 5
Public Feedback drove key changes from PD to PF Key Changes Comment to Proposed Final Document Document Key terms Key terms not explained Key terms explained factors and rationale Rationale and explanation of Added section explaining aspects other factors not explained related to factors for framework. Nomenclature Inconsistent use of terms Consistent use of terms Reversed I = Low to SaMD Numbering I = Very High to IV = Low IV = Very High Examples Too few, some not aligned to Added examples, aligned to SaMD SaMD logic logic Controls Section for ‘Recommended Section for ‘General and Special Controls & Oversight’ Considerations for development and manufacture of SaMD’ Classification Alignment to classification not Analysis of SaMD categories to addressed regulatory classification added to appendix 8/15/14 6
Framework Overview SaMD definition statement: • Significance of recommendation • Context of use General and Special Risk Categorization Controls Considerations Type Level of Risk Common process IV 4 Categories expectation 9 criteria based based on similarity on definition III of impact statement II I 8/15/14 7
SaMD Definition Statement A clear statement that identification of SaMD category Includes the following key information: – The significance of information provided by SaMD: Treats or diagnose, Drives clinical management; informs clinical management – The Context of use of the SaMD: who is it for, how used, patient condition, target population, target disease, limitations of SaMD output. – A Description of the SaMD ’ s core functionality : what features/functions are essential to the intended medical purpose and context of use that will determine considerations for managing changes. 8/15/14 8
SaMD Categorization Principles • SaMD impact and resultant category relies on an accurate and complete SaMD definition statement provided by the manufacturer • Categories are a result of combination of significance of the information provided by the SaMD to the healthcare decision and the healthcare situation or condition • Categories are based on the levels of impact on the patient or public health • Categories are in relative significance to each other. Category IV has the highest level of impact, Category I the lowest. • SaMD functionality that span across multiple healthcare situations or conditions or provide information of varying significance are categorized at the highest level of impact when can be used • SaMD has its own category even when interfaced with other SaMD, other hardware medical devices, or used as a module in a larger system 8/15/14 9
Criticality of context Significance of information • Critical situation or condition • To treat or to diagnose – where accurate and/or timely – To provide therapy to a human body; diagnosis or treatment action is vital to – To diagnose/screen/detect a disease avoid death, long-term disability or or condition other serious deterioration of health of • To drive clinical management an individual patient or to mitigating – To aid in treatment by providing impact to public health. enhanced support to safe and effective • Serious situation or condition use of medicinal products or a medical – where accurate diagnosis or treatment device. is of vital importance to avoid – To aid in making a definitive diagnosis. unnecessary interventions – To triage or identify early signs of a • Non-Serious situation or condition disease or conditions. – where an inaccurate diagnosis and • To Inform clinical management treatment is important but not critical – To inform of options for interventions – To provide clinical information by aggregating relevant information 8/15/14
SaMD Categorization Increasing significance Significance of Information Provided by SaMD to Healthcare Decision State of Healthcare Treat or Drive Clinical Inform Clinical Situation or Diagnose Management Management Condition Increasing criticality IV III II Critical III II I Serious II I I Non-Serious 8/15/14 11
SaMD Types Landscape/Scope Catastrophic Very High I m p a c t Not High SaMD (Part of MD Medium / Type Embedded IV in MD) Type Type Low III III Type Type Type II II II Type Type Type None I I I Not SaMD Retrieves Optimizes Informs Treat/ Treat/ Closed Loop Informs Diagnoses Diagnoses information Process serious Interventions critical non serious serious Decisions No Clinical Decisions Intermediary Organizes Informs non- Drives non- Drives Drives Treats/ Data serious serious serious critical diagnoses Decision Decisions Decisions Decisions critical F u n c t i o n a l i t y
General and Special Considerations for SaMD General Considerations • SaMD often forms part of a • Design and development clinical workflow • Changes • Issues with design/implementation of Special Considerations SaMD can lead to user error • Socio-technical environment • Software testing generally • Technology and system environment recognized as not sufficient to • Information security with respect to determine safety safety The combination of risk management, quality management and methodical and systematic systems engineering according to industry best practices can help SaMD manufacturers follow a clearly structured and consistently repeatable decision-making process to promote safety for SaMD 8/15/14 13
General Considerations for SaMD Design and • Safety needs to be addressed early in the design and development process Development • SaMD changes may have a significant Changes unforeseeable effect on the healthcare situation or condition and socio-technical environment of use if not managed systematically, not only with respect to a design change in itself, but also to the impact of the changed software after it is installed and implemented 8/15/14 14
Special Considerations for SaMD • Proper and safe functioning of SaMD is highly Socio- dependent on a sufficient and common understanding technical of the socio-technical environment that includes the environment manufacturer and the user Technology • SaMDs are always dependant on a hardware platform and system and often a connected environment. SaMD can be environment affected by cross-link interconnections – both physical connections and interoperability, i.e., the seamless communication between devices, technology and people. Information security with respect to safety • Incorrect management or transmission of information by Information an SaMD can lead to incorrect or delayed diagnosis or security with treatment respect to safety 8/15/14 15
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