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POLMED Presentation I7 US Market Entry Considerations 22 June 2021 Rick Proctor Jeff Smith US Market Entry Considerations QUESTIONS? A copy of this presentation will be Post any questions onto the Webex Chat. sent to you following the session We’ll answer them at the end of the session US Market Entry Considerations Agenda FDA Current Pathways Software as a Medical Device (SaMD) Mobile Medical Apps Laboratory Developed Tests (LDTs) Quality Systems - ISO vs. FDA Intellectual Property US Government Contracting Promotional Practices Questions Current Pathways1 1. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device Class I Class II Class III De Novo General Controls General Controls General Controls and & Special Controls Premarket Approval • Feedback Controls - • Feedback Controls - • Feedback Controls • No predicate, new traceability, complaint traceability, complaint technology handling handling • Design Controls • Classification/pathway • Design Controls - design • Mfg Controls - supply • No Design Controls chain established w/ based on risk (None, input/output, verification/ 510(k) or PMA) • No 510(k) - product listed validation restrictions on changes w/FDA, begin marketing/ distribution • Clinical Evidence - • Clinical Evidence - possible, at FDA required for safety and discretion, for safety and efficacy efficacy • Pre-Market Approval • 510(k) comparing device (PMA) - submission + vs. predicate(s) clinical evidence FDA - Device Classification1 Classification Panel - 513(g) Request OR 21 CFR 862-892 - - (fee required) Formal Request Research Follow clearance process outlined in classification regulation for your device 1. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device Software as a Medical Device SaMD Definition May be used in combination with other medical devices, other SaMD or general purpose software May include in-vitro-diagnostic Software2 intended to be used for one or Capable of running on general purpose platforms more medical purposes Provide means and suggestions for mitigation of a disease that perform these Provide information for determining compatibility, detecting, diagnosing, monitoring or purposes without being treating physiological conditions, states of health, illnesses or congenital deformities part of a hardware Aid to diagnosis, screening, monitoring, determination of predisposition; prognosis, medical device3 prediction, determination of physiological status Mobile apps that meet this definition May be used in combination with other medical devices, other SaMD or general purpose software 2. IMDRF/SaMD WG/N10FINAL:2013 Software as a Medical Device (SaMD): Key Definitions 3. IMDRF/SaMD WG/N12FINAL:2014 Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations Examples that ARE SaMD3: Provides parameters Diagnosis of a CAD - computer- that become the Allows a condition using aided detection input for a different commercially the tri-axial software running on hardware medical available smartphone accelerometer that a general purpose device or other to view images for operates on the computing platform SaMD (e.g. treatment diagnostic purposes embedded processor located in the image- planning software obtained from an on a consumer acquisition hardware that supplies MRI medical device digital camera medical device information used in a linear accelerator) 3. IMDRF/SaMD WG/N12FINAL:2014 Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations Examples that are NOT SaMD3: Relies on data from a Integrates and medical device, but Used to “drive or Software that analyzes laboratory does not have a control” the motors monitors X-Ray tube quality control data medical purpose and the pumping of performance to to identify increased (e.g., software that medication in an anticipate the need random errors or encrypts data for infusion pump for replacement trends in calibration transmission from a on IVDs medical device) 3. IMDRF/SaMD WG/N12FINAL:2014 Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations SaMD Intended Use/ Characterization Intended Purpose Intended Use/Intended Purpose4 The term “intended use / intended purpose” is the objective intent of the manufacturer regarding the use of a product, process or service as reflected in the specifications, instructions and information provided by the manufacturer 4. GHTF/SG1/N70:2011 “Label and Instructions for Use for Medical Devices” SaMD3,5 QS Significance Healthcare Core of Information Situation/Condition Functionality Requirements IEC SaMD Definition Statement 62304 Design SaMD Characterization SaMD Development Testing Use Maintenance 3. IMDRF/SaMD WG/N12FINAL:2014 Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations 5. IMDRF/SaMD WG/N23 FINAL:2015 Software as a Medical Device (SaMD): Application of Quality Management System SaMD FDA believes an “agile regulatory paradigm is necessary to accommodate the faster rate of development and potential for innovation in software-based products6” QS Significance Healthcare Core of Information Situation/Condition Functionality Requirements IEC SaMD Definition Statement 62304 Design with this… in place… SaMD Characterization SaMD Development Testing Use Maintenance FDA is establishing a voluntary pathway… to assess the safety and effectiveness of software technologies without inhibiting patient access to these technologies. 6. Software Precertification Program: Working Model – Version 0.2 – June 2018 Software Precertification Pilot Program6 6. Software Precertification Program: Working Model – Version 0.2 – June 2018 Mobile Medical Applications (MMAs) Footnote: In 2019 FDA revised guidance language, replacing “mobile applications with “software functions” Mobile Medical Applications (MMAs) FDA guidance first issued 2013, updated 2015 and 2019 Software that 1. runs on a mobile platform 2. accessed via mobile platform but web-based and runs on a server 3. performs medical device functions Mobile platform is handheld, off-the-shelf, commercial computing platform, with or without wireless connectivity (smartphone, iPad) Regulated (Targeted) MMAs Criteria #1 Criteria #2 Criteria #3 Meets “function specific” • Used as an accessory to a • Functionality could pose a medical device definition regulated medical device, risk to a patient’s safety if below or the device were to not • Intended for use in the • Transforms a mobile function as intended diagnosis or the cure, platform into a regulated mitigation, treatment of medical device prevention of disease, or • Affects the structure or any function of the body If Regulated MMA… Premarket submission required for approval or clearance (510k, De Novo, or PMA) Establishing registration and medical device listing Studies supporting safety and efficacy Quality system regulation Product labeling Adverse-event reporting Examples of Regulated MMAs Apps that transform a Apps that provide patient-specific Apps that control medical devices mobile platform into a medical analysis and diagnosis or (Accessories) device with attachments, displays, treatment recommendations sensors Controls blood Attachments to read Calculate dosage pressure cuff inflation/ glucose strips, collect/ for treatment plan deflation and reading monitor ECG Control insulin delivery Motion sensors to CAD image via signal transmission monitor sleep apnea, processing to pump electronic stethoscopes Enforcement Discretion MMAs FDA does not intend to regulate these, but can • Software that helps users self-manage their disease or conditions without providing specific treatment or treatment suggestions • Software that automates simple tasks for health care providers • Coaching software – help users manage conditions like obesity, diabetes, mood disorders • Practice/treatment guidance for clinicians – matches patient condition to published treatment guidance • Telemedicine software – facilitates/enhances communication b/w patient and clinician Examples • Routine calculations – BMI, APGAR Unregulated (by FDA) Medical Software Unregulated because it does not meet definition of medical device Access copies of reference materials Training and education for clinicians Patient education Office/practice management Patient logs, health tracking aids Transfer, store, reformat, display data from a regulated MMA without changes Intended Use Drives Functionality Intended Use Labeling The objective intent All labels, written, printed, or graphic of the persons matter legally responsible 1. upon any article or any of its for the labeling containers or wrappers, or 2. accompanying such article • Labeling claims, advertising matter, oral or written statements, sales training materials • Your exposure (including criminal charges) is when the device is offered and used for a purpose for which it is neither labeled nor advertised Laboratory Developed Tests (LDTs) Laboratory Developed Tests (LDTs) Before defining LDTs, you LDTs are a subset must understand in vitro of IVDs diagnostic tests (IVDs) • Reagents, instruments, or • Designed, manufactured and used systems used to analyze human within a single laboratory for samples clinical use • Clinicians rely on them to • Used to inform clinicians and diagnose disease or other patients conditions, guide treatment, or • LDTs regulated by Center for mitigate/prevent future disease Medicaid and Medicare
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