Our medtech experts are yours. 510(k)s for Connected Medical Devices.
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1 Our medtech experts are yours. 510(k)s for Connected Medical Devices. David Amor, MSBE, CQA Principal, Medgineering
2 Agenda. What is a 510(k)? How do we determine regulatory strategy for connected health devices? Recreate actual decision making for RemindTrac. Note: some made up truths to protect IP/ strategy.
3 A medtech quality & regulatory consulting firm. Advisor Dr. Susan Alpert former FDA Director, former Medtronic SVP, industry thought leader
4 Let s get started.
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6 Use a connected device to RT monitor and empower patients.
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8 A smart connected pillbox. Bluetooth coupled to mobile app. Alert you to take medications. Prompts health and behavioral questionnaires for well-being. Holds 2X AM/ PM doses.
9 A mobile app.
10 A caregiver platform.
11 We determined that it was time to assess whether we needed to go to the FDA as a medical device.
12 Is my product even a medical device?
13 Is my product even a medical device? Devices. 201(h) Instruments, apparatus, etc. does not achieve intended use using chemical/ metabolism. "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory [ ] for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, [ ] and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
14 Not a drug, clearly. Definitely an instrument, apparatus, etc. Will it be used to cure, prevent, mitigate a disease?
15 Intended Use. Will it be used to cure, prevent, mitigate a disease?
16 But how about connected devices? Intended for use in diagnosis of retinopathies. Same thing as ophthalmoscope, which is a medical device.
17 But how about connected devices? Accessory to medical device + drug product. Regulated as a medical device.
18 But how about connected devices? Intended for use in detecting blood glucose. Same thing as a glucometer.
19 MMA FDA Guidance.
20 Not regulated. Enforcement discretion. Regulated. Meet definition of medical device. Intended for use as accessory or to transform med device.
21 Intended Use is the key. A light emitting diode and flashlight app on an iphone Not a regulated medical device.
22 Intended Use is the key. istethoscope that detects heart rate. This is a regulated medical device. It is a mobile version of a regulated device.
23 OK. We think this is a medical device now because we want to give it an Intended Use. How do we get a regulated medical device to market in the US?
24 How does my medical device get to market? also, what is a 510(k)?
25 21 CFR 820 (QSR) Registration & Submission Submitting a Medical Device in United States General controls + 510(k) or PMA depending on risk and intended use of device Implement a quality management system Why do I need to comply to ISO 13485?
26 Show FDA that your company is under a state of control + submit a 510(k) (Premarket Notification) Class I Class II Class III LOW RISK MEDIUM RISK HIGH RISK General Controls General Controls + Special Controls General Controls + Premarket Approval
27 Pre-market notification Section 510(k) of FD&C Mainly used for Class II devices (some Class I) ~75% Requires demonstration of substantial equivalence of a product against a predicate
28 Pre-market notification Traditional (85%) Special (20%) Abbreviated (5%)
29 Click to edit Master title style Substantial Equivalence Substantial Equivalence Technological Characteristics Intended Use
30 Click to edit Master title style Substantial Equivalence Substantial Equivalence = & Intended Use or Technological Characteristics Different tech characteristics + No new safety or efficacy concerns
31 Click to edit Master title style Technological characteristics can be categorized into: a. Energy type b. Environmental specifications c. Performance specifications d. Ergonomics of the patient-user interface e. Dimensional specifications f. Software or firmware g. Packaging or expiration dating h. Sterilization Technological Characteristics
32 510(k) Content (21 CFR )
33 How do I arrive at a decision for a 510(k)?
34 We need to do some research. Let s look at similar products and if applicable, find a predicate?
35 How about a medication reminder or pill box?
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40 Predicate: Inrange Systems EMMA Class II device product code NZH. Because the EMMA more closely resembles our intended use, and the tech characteristics are more similar.. 510(k)
41 The 510(k). Tips for connected & mhealth products.
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43 ABBREVIATED 510(k)! Yes!
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45 Levels of Concern Software. Minor. Moderate. Determining level of concern guides the depth/ breadth of the 510(k) content. Major.
46 Boilerplate information. Product info. Substantial Equivalence assessment.
47 Product info. Device descriptions should describe the product and the ecosystem, including interoperability.
48 Mapping out the clinical use of your product makes it easy to craft design input requirements the basis of your design. Upload and schedule meds and/or clinical assessments Physician or healthcare provider establishes medication schedule/assessment with/for patient Med schedule/clinical assessment is uploaded to portal (meds from Elsevier Gold Standard ) Portal syncs to app and transmits medication/assessments Care Coordinator Response Mobile device app or desktop emits audible and visual reminder when medication/assessment time arrives Caregiver /Patient accepts reminder by clicking in app, or dispensing through case (if assessment then answer it) POSITIVE EVENT Caregiver/Patient ignores reminder. Med/Assessment report goes to portal to be reviewed by providers Reminders ignored until max interval is reached. NEGATIVE EVENT PROVIDER S ACTIONABLE DECISION BASED ON REPORTS IN PROVIDER S PORTAL
49 Product info. Describe USER NEEDS + DESIGN INPUT REQUIREMENTS. The product should dispense four individual doses in an AM- AM PM PM progression. Ok we ll need some requirement for size, compartments, software cues
50 Battery life. USB charging capable. Materials / drop test. Box dimensions. Compartment sizes. IPX ratings.
51 Battery life. Response/ latency. BLE compatibility. Cache. Flowchart. Pairing requirements.
52 Product info.
53 Product info. ADMIN LEVEL Benchmarking providers Monitor provision of servicers by provider Measurable quality goals and incentive opportunities ADMINISTRATOR PORTAL INTERVENTION LEVEL Schedule Track Alert CARE COORDINATOR PORTAL PCP & Care Coordinators MOBILE APP LEVEL Portable Interactive (messaging, med diary) Reminders MOBILE APP DEVICE Patient or Home Community Based Providers* * Home and Community Based Providers could be: Nursing Home Home Health Agency School Based Clinics Family Member Group Home Personal Care Assistant
54 Substantial Equivalence. The substantial equivalence discussion should take a black box approach whenever possible. With connected medical devices, the technological characteristics are frequently different than the predicate.
55 Programmed meds schedule. Patient information. Medications. Rx filled by care providers. Meds dispensed automatically. Meds packeted. Software confirms event. Med marked as taken.
56 Intended Use not impacted because clinical goal still achieved! Programmed meds schedule. Patient information. Medications. Rx filled by care providers. Meds dispensed automatically. Meds packeted. Software confirms event. Med marked as taken.
57 EN ISO 14971:2012 IEC Meds dispensed automatically. Meds packeted. Rx filled by care providers. Have to demonstrate that these technological characteristics do not make the product less safe or effective!
58 Usability/ HFE. Consider the use environments of mobile platforms and connected products. Mobile platforms that are home use devices are more prone to environmental influences: light, weather, humidity, temperatures, etc.
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62 Can you think of any usability concerns? SO DAMN HARD TO OPEN THAT BOX! PILLS FLYING EVERYWHERE!
63 Safety and risks. Consider the risks to the patient.and the user! With connected health products, the patient will often be the end-user. However, there are many products where the user of the product is the caregiver who interacts with the product to give therapy to the patient.
64 Safety and risks. Consider the risks to the patient.and the user!
65 Testing. Testing is conducted to support substantial equivalence findings. SYSTEM TESTING Hardware testing. Software testing. HRS. SRS.
66 Drop Testing. HRS.
67 Software Validation. SRS.
68 Software Validation. SRS.
69 Software Validation. SRS.
70 System Testing. HRS + SRS. END TO END.
71 Simulated Use Testing. Connected devices should conduct design validation under simulated use condition and while replicating fault conditions. Warnings / mitigations should also be tested.
72 Simulated Use Testing. Before the medication package is inserted into the medication delivery unit, a dose is removed from the medication package and administered to the patient. (This is similar to a situation where a power failure causes the patient to manually administer his medications without the use of the medication delivery unit.) Adequate software and hardware controls should be in place to prevent the medication delivery unit from attempting to deliver a dose that is missing from the package. The device should be capable of identifying whether medications are missing from the [case].
73 Cybersecurity. Incorporate cybersecurity testing. Create design inputs for cybersecurity! IDENTIFY PROTECT DETECT RESPOND RECOVER. HAZARD ANALYSIS. TRACE MATRIX. IFU CONTROLS. VAL RECORDS.
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75 Our medtech experts are yours. Questions?
76 BACKUP SLIDES
77 Next steps. Fill out Usability Questionnaire. Determine scope of work (DiaSorin) Training Usability process development Medgineering proposal.
78 What do they regulate? Devices. 201(h) "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized Instruments, apparatus, etc. does not achieve intended use using chemical/ metabolism.
79 US Device Classifications 21 CFR 860 Classified according to risk and criticality to patient/ end-user (3) letter code groupings with names and attributes Used to track adverse events and field actions As new classification product codes are created, a device may be reassigned into a new product code. Guidance exists for identifying the scope and critical aspects of a product code.
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81 A GUIDANCE DOCUMENT EXISTS! Review and use to determine scope of testing, understand FDA requirements, etc.
82 US Device Classifications 21 CFR 860 Class I Class II Class III not intended to help support or sustain life or be substantially important in preventing impairment to human health, and may not present an unreasonable risk of illness or injury Device classification helps determine regulatory submission strategy and level of control. more critical than Class I but designed to perform as indicated without causing injury or harm to patient or user. support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury LOW RISK MEDIUM RISK HIGH RISK
83 Class I Class II Class III not intended to help support or sustain life or be substantially important in preventing impairment to human health, and may not present an unreasonable risk of illness or injury more critical than Class I but designed to perform as indicated without causing injury or harm to patient or user. support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury LOW RISK MEDIUM RISK HIGH RISK General Controls General Controls + Special Controls General Controls + Premarket
84 General Controls Basic requirements for all medical device companies per MDA Applies to all devices; Class I only has to follow general controls (with some exceptions) Includes provisions: Adulteration Misbranding Device registration and listing Premarketing notification (exemptions in XXX.9s) Banned devices Notification repair, replacement, refund
85 Special Controls Regulatory requirements for class II devices General controls alone are insufficient to provide reasonable assurance of the safety and effectiveness of the device Special controls are usually device-specific and include: o o o Performance standards Postmarket surveillance Patient registries
86 Special Controls
87 Class I Class II Class III
88 Class I Class II Class III LOW RISK MEDIUM RISK HIGH RISK General Controls General Controls + Special Controls General Controls + Premarket Approval Show FDA that your company is under a state of control be implemeting a scaled quality
89 Show FDA that your company is under a state of control + submit a 510(k) Class I Class II Class III LOW RISK MEDIUM RISK HIGH RISK General Controls General Controls + Special Controls General Controls + Premarket Approval
90 Show FDA that your company is under a state of control + submit a Pre-Market Approval (PMA) Class I Class II Class III LOW RISK MEDIUM RISK HIGH RISK General Controls General Controls + Special Controls General Controls + Premarket Approval
91 Submitting a Medical Device in Europe Compliance to 90/385/EEC for Active Implantable Devices (AIMD) Compliance to 93/42/EEC for Medical Device Directive (MDD) Notified Body ISO QMS Declaration of Conformity, Technical File
92 The 2 main pathways of getting to US market. Pre-market notification Pre-market approval (PMA)
93 The 2 main pathways of getting to US market. Reference: Pina & Pines, A Practical Guide to Food and Drug Law and Regulation, 3ed.
94 Click to edit Master title style The 510(k) Premarket Notification Section 510(k) of FD&C Act Mainly reserved for Class II devices w/ exceptions (25%) Limitations of exemptions found in.9 sections No Form 510(k) but guidance in 21 CFR 807 Sub E When a 510(k) is required/ not required Format
95 Click to edit Master title style The 510(k) Substantial Equivalence Substantial Equivalence Technological Characteristics Intended Use
96 Click to edit Master title style The 510(k) Substantial Equivalence Substantial Equivalence = Intended Use & or Technological Characteristics Different Technological Characteristics + No new safety or efficacy concerns
97 Click to edit Master title style The 510(k) Substantial Equivalence = A change in information about indications for use does not automatically discount same intended use! Substantial Intended Use Equivalence An intended use statement includes a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including a description, where appropriate, of the patient population for which
98 Click to edit Master title style The 510(k) Substantial Equivalence Technological characteristics can be categorized into: a. Energy type b. Environmental specifications c. Performance specifications d. Ergonomics of the patient-user interface e. Dimensional specifications f. Software or firmware Technological Characteristics
99 Click to edit Master title style The 510(k) Substantial Equivalence If your device has different technological characteristics than the predicate device, you must objectively demonstrate that it is as safe and effective as the predicate. Technological Characteristics Different Technological Characteristics + No new safety or efficacy concerns
100 Click to edit Master A New title 510(k) style Paradigm 1998
101 Pre-market notification Traditional Special (20%) Abbreviated (5%)
102 Pre-market notification Special Typically used for me-too products iterative or Gen II OR Preamendment devices being resubmitted.
103 Pre-market notification Abbreviated Special case where there is a guidance document or a recognized standard that a company may leverage.
104 510(k) Content (21 CFR )
105 510(k) Content (21 CFR ) Admin paperwork (cover pages, statements Device information: name, intended use, classification Company information: location, certifications Labeling Substantial equivalence assessment o o Device specifications and reference applicable guidance documents, special controls, or standards; photographs or engineering drawings Testing data
106 510(k) Data
107 510(k) Data
108 The SE Letter.
109 Click to edit Master title style As soon as your product hits the market You must implement a quality management system (QMS). a.k.a follow the GMPs
110 Pre-approval inspection after a company submits an application to FDA to market a new product Routine inspection of a regulated facility For-cause inspection to investigate a specific Click to edit Master title style FDA Inspections
111 In summary. Most mobile apps are not medical devices under section 201(h) of FD&C act Although some mobile apps meet the definition of a medical device, they will be enforced by discretion because they pose low risk.
112 Classification of MMAs. Not regulated. Regulated by enforcement discretion Regulated.
113 What devices are regulated? A mobile medical app to be considered and regulated as a medical device must: 1. Meet the definition of medical device per FD&C Act Section 201(h) and 2. Be intended for use a) as an accessory to a medical device or
114 Medical Device per 201(h) Key Terminology Intended Use Instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body What the device does, medically. Intended use may show up in labeling, claims, advertising materials or written
115 The key difference. Focus is on intended use, not platform. =
116 The key difference. A light emitting diode and flashlight app on an iphone Not a regulated medical device.
117 The key difference. LED illumination of retina for diagnosing eye disease. This is a regulated medical device because it is given an intended use.
118 An example. istethoscope that detects heart rate. This is a regulated medical device. It is a mobile version of a regulated
119 An example. Pulse oximeter that reads out into your smartphone. This is a regulated medical device. It is a mobile accessory to an
120 Apps that will be regulated Mobile apps that are extensions of one or more medical devices by connecting, displaying, storing, analyzing or transmitting patient-specific medical device data.
121 Pre-market notification Special Typically used for me-too products iterative or Gen II OR Preamendment devices being resubmitted.
122 Pre-market notification Abbreviated Special case where there is a guidance document or a recognized standard that a company may leverage.
123
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