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Attorney Client Communication – Privileged and Confidential FDA REGULATORY FRAMEWORK FOR DEVICES Bradley Merrill Thompson Epstein Becker & Green June 7,

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Presentation on theme: "Attorney Client Communication – Privileged and Confidential FDA REGULATORY FRAMEWORK FOR DEVICES Bradley Merrill Thompson Epstein Becker & Green June 7,"— Presentation transcript:

1 Attorney Client Communication – Privileged and Confidential FDA REGULATORY FRAMEWORK FOR DEVICES Bradley Merrill Thompson Epstein Becker & Green June 7,

2 Attorney Client Communication – Privileged and Confidential Roadmap 1. Exercise Overview 2. Health IT Use Case – Mechanical Ventilation Weaning 3. FDA Device Regulatory Framework Title 21 – Subchapter H of the CFR 4. Big Picture Assessment 2

3 Attorney Client Communication – Privileged and Confidential Exercise Overview Review Health IT Use Case – Mechanical Ventilation Weaning Review the FDA’s current regulatory framework: Discuss how well does the current regulatory framework function to classify and regulate a Health IT Fits/No Changes Changes Needed/Unique Considerations Doesn’t Fit 3

4 Attorney Client Communication – Privileged and Confidential Health IT Use Case – Mechanical Ventilation Weaning Description of Device: Software that recommends when to discontinue post-operative mechanical ventilation based on comparing patient data to acceptable threshold ranges of a number of factors, including spontaneous respirations, normal body temperature, blood alkalinity/acidity, ventilation mode, partial pressure of oxygen, partial pressure of carbon dioxide, spontaneous tidal volume, inspired oxygen fraction, negative inspiratory force, positive end-expiratory pressure. Device Uses: Post-operative patients require mechanical ventilation due to airway problems, inability or failure to ventilate or oxygenate subsequent to surgery, or due to phrenic nerve paralysis, possibly resulting due to the effects of sedation and paralytics associated with surgery. When the patient recovers, it is necessary to wean off of mechanical ventilation. Labeling: Software recommends optimal point to wean patient from mechanical ventilation 4

5 Attorney Client Communication – Privileged and Confidential 5 21 CFR Chapter 1: FDA, Subchapter H: Medical DevicesApplies?Fits? 801 Labeling 803 Medical Device Reporting 806 Corrections and Removals 807 Registration and Listing (Part E Pre-Market Notification) 808 Exemption from Fed Preemption of State and Local Reqts 809 In Vitro Diagnostics (IVD) If accessory 810 Recall Authority 812 Investigational Device Exemption (IDE) 814 Premarket Approval (PMA) Small subset of HIT 820 Quality System 821 Medical Device Tracking N/A 822 Post Market Surveillance If required 860 Medical Device Classification 861 Procedures for Performance Standards Development Specific Product Classifications 895 Banned Devices Low likelihood 898 Performance Std For Electrode Lead Wires And Patient Cables N/A

6 Attorney Client Communication – Privileged and Confidential Part Labeling General Purpose: Serves the purposes of: (i) identifying and describing legally responsible persons for a particular medical device; (ii) specifying the type of information and content that must be on a medical device label; and (iii) stating exemptions to labeling requirements. Breakdown: Subpart A – General Labeling Provisions Identification of and minimum information regarding responsible persons Subpart C – Labeling Requirements for Over-the-Counter (OTC) Devices Specific information, warning and quality requirements for OTC devices Subpart D – Exemptions from Adequate Directions for Use Describes circumstances where directions for use do not need to be included Subpart E – Other Exemptions Exemptions related to shipments and deliveries of devices Subpart H – Special Requirements for Specific Devices Specific requirements and exemptions for enumerated devices How Does this Fit with Health IT? Unique considerations for labeling that is incorporated in the software product. Labeling changes may require product changes and have design controls impact. 6

7 Attorney Client Communication – Privileged and Confidential Subpart A – §801.1 – Labeling – Name and place of business Regulatory Requirement: The label of a medical device must “conspicuously” specify both the name and place of business of the manufacturer, packer, or distributor of the device Purpose or Risk Mitigated: Helps prevent ambiguity in determining who the responsible party for the device is by specifying not only the manufacturer, but also others in the chain of control of the device (e.g. packer/distributor). How Does this Fit with Health IT? Unique considerations for labeling that is incorporated in the software product. Labeling changes may require product changes and have design controls impact. 7

8 Attorney Client Communication – Privileged and Confidential Subpart A – §801.4 – Labeling - Meaning of Intended Uses Regulatory Requirement: The intended use of the devices is determined by the objective intent of the persons legally responsible for the device Purpose or Risk Mitigated: Ensures that devices which are intended to be medical devices are regulated as such, preventing both over regulation and under regulation. How Does this Fit with Health IT? Unique considerations for labeling that is incorporated in the software product. Labeling changes may require product changes and have design controls impact. 8

9 Attorney Client Communication – Privileged and Confidential Subpart A – §801.5 – Labeling – Adequate Directions for Use Regulatory Requirement: The directions for us on the label must be understandable to a lay person and enable such person to use a device safely and for the purposes for which it is intended. Purpose or Risk Mitigated: Prevent the risk of an end user misusing the device and injuring themselves or others due to insufficient directions on the label How Does this Fit with Health IT? Important to consider consumer use of Health IT products. Unique considerations for labeling that is incorporated in the software product. Labeling changes may require product changes and have design controls impact. 9

10 Attorney Client Communication – Privileged and Confidential Subpart A – §801.6 – Labeling – Misleading Statements Regulatory Requirement: A device is misbranded if the labeling contains a false or misleading representation with respect to another device, drug, food or cosmetic. Purpose or Risk Mitigated: Prevent the risk of confusion amongst different devices and certain other products due to a representation in the labeling. How Does this Fit with Health IT? Unique considerations for labeling that is incorporated in the software product. Labeling changes may require product changes and have design controls impact. 10

11 Attorney Client Communication – Privileged and Confidential Subpart A – § – Labeling –Prominence of Required Label Statements Regulatory Requirement: A label must have the prominence and conspicuousness required by section 502(c) of the Food, Drug and Cosmetic Act and must be in English*. Purpose or Risk Mitigated: The purpose is to decrease the risk of harm to the user due to failure to see and appreciate information on the label because of a lack of “visibility” of an element of the label or a foreign language issue. How Does this Fit with Health IT? Unique considerations for labeling that is incorporated in the software product. Labeling changes may require product changes and have design controls impact. 11 * – Spanish language acceptable for products distributed solely in Puerto Rico

12 Attorney Client Communication – Privileged and Confidential Subpart C – § to § – Labeling Requirements for Over-the-Counter Devices Regulatory Requirement: Over-The-Counter(OTC) Devices must comply with specific requirements, including: (i) the most visible aspect of the label to the consumer (i.e. the principal display panel); (ii) the statement of identity including intended action and common name; (iii) declaration of quantity and (iv) warning statements for certain devices. Purpose or Risk Mitigated: The purpose of specific disclosures and labeling requirements is to account for the increased likelihood that a lay person will be using the device without obtaining prior instruction from a health care professional such as a physician. How Does this Fit with Health IT? Important to consider consumer use of Health IT products. 12

13 Attorney Client Communication – Privileged and Confidential Subpart D – § – Labeling – Exemptions for Adequate Directions for Use Regulatory Requirement: Adequate directions are not required for certain devices that must be used only under the supervision of an adequately supervised practitioner, due to the likelihood of harm to a user, the complexity of the method of use and/or the collateral measures necessary for safe use. Purpose or Risk Mitigated: The risk for certain devices is so great that adequate directions for use cannot be stated in a label. The risk is mitigated by ensuring that access is only available to such devices in conjunction with supervision by an appropriate practitioner. How Does this Fit with Health IT? Applicable/Fits. 13

14 Attorney Client Communication – Privileged and Confidential Subpart D – § – Labeling – Retail Exemption for Prescription Devices Regulatory Requirement: Prescription devices under § delivered by a licensed practitioner or pursuant to a prescription are exempt from the labeling requirements under Section 502(f)(1) of the Food, Drug and Cosmetic Act provided that such practitioner makes certain disclosures and provides certain direction for use. Purpose or Risk Mitigated: The risk of harm to the end user is mitigated when a qualified practitioner is in a position to provide additional instructive and cautionary information to the end user. How Does this Fit with Health IT? Applicable/Fits. 14

15 Attorney Client Communication – Privileged and Confidential Subpart D – § – Labeling – Medical Devices Having Commonly Known Directions Regulatory Requirement: Devices with common uses that are known to he ordinary individual do not need to list adequate directions for use. Purpose or Risk Mitigated: The risk of harm to the end user is mitigated when the average person expected to use the device will already be aware of the directions for use. How Does this Fit with Health IT? Important to consider consumer use of Health IT products. 15

16 Attorney Client Communication – Privileged and Confidential Subpart D – § – Labeling – Medical Devices for processing, repacking, or manufacturing Regulatory Requirement: Devices meant to be processed, repacked or used in the manufacture of another drug or device are exempt from Section the labeling requirements under 502(f)(1) of the Food, Drug and Cosmetic Act if they employ a cautionary label. Purpose or Risk Mitigated: Devices that meet this exemption are not intended to be used by a user in their current state and thus there is a lower degree of risk associated with such products. How Does this Fit with Health IT? Not consider application to software modules. 16

17 Attorney Client Communication – Privileged and Confidential Subpart D – § – Labeling – Medical devices for use in teaching, law enforcement, research, and analysis. Regulatory Requirement: Devices meant to be used in instruction law enforcement, research, chemical analysis or physical testing are exempt from the labeling requirements under Section 502(f)(1) of the Food, Drug and Cosmetic Act so long as such activities do not involve clinical testing. Purpose or Risk Mitigated: Devices that meet this exemption are not intended to be used by a user for the purposes of clinical treatment and thus the risk of harm is mitigated. How Does this Fit with Health IT? Applicable. 17

18 Attorney Client Communication – Privileged and Confidential Subpart E – § – Labeling – Other Exemptions Regulatory Requirement: Exempts certain medical devices to be processed, labeled, ore repacked that are in interstate commerce. Purpose or Risk Mitigated: Like the similar exception for such devices described earlier in Section , the risk with these devices is decreased since they will be modified and subject to further regulation before they reach a user. How Does this Fit with Health IT? Not consider application to software modules. 18

19 Attorney Client Communication – Privileged and Confidential Part 803 – Medical Device Reporting General Purpose: Governs required reports by medical device user facilities, manufacturers, importers and distributors. Reports are required by multiple types parties in conjunction with various triggers. Breakdown: Subpart A – General Provisions General summary of reporting requirements and procedural requirements for reports Subpart B – Generally Applicable Requirements For Individual Adverse Event Reports Subpart C – User Facility Reporting Requirements Subpart D – Importer Reporting Requirements Subpart E – Manufacturer Reporting Requirements 19

20 Attorney Client Communication – Privileged and Confidential Subpart A – §§803.1 to.19 – Medical Device Reporting – General Provisions Regulatory Requirement: This subpart provides a general overview of the procedures to be followed when making reports related to medical device adverse events. Purpose or Risk Mitigated: The purpose is to standardize information received from various sources concerning adverse events and ensure that the information available is accurately collected. How Does this Fit with Health IT? Applicable/Fits. 20

21 Attorney Client Communication – Privileged and Confidential Subpart B – §§ to.22 – Medical Device Reporting – Individual Adverse Event Reports Regulatory Requirement: Details requirements and procedures for reports of individual adverse events for various entities including: (i) optional reports for individuals and health care professionals and (ii) mandatory reporting for user facilities, manufacturers and importers. Purpose or Risk Mitigated: Purpose is to standardize the procedures and timing of reports for all of the entities mentioned above How Does this Fit with Health IT? Applicable/Fits. 21

22 Attorney Client Communication – Privileged and Confidential Subpart C – §§ to.33 – Medical Device Reporting – User Facility Reporting Requirements Regulatory Requirement: User facilities are required to report to the FDA upon discovery that a device may have caused or contributed to the death of a patient. User facilities must also report to the manufacturer, or the FDA if the manufacturer is unknown, if a device may have caused a serious injury to a patient. Purpose or Risk Mitigated: Purpose is to ensure that adverse events caused by medical devices are reported by user facilities. How Does this Fit with Health IT? Applicable/Fits. 22

23 Attorney Client Communication – Privileged and Confidential Subpart D – §§ to.42 – Medical Device Reporting – Importer Reporting Requirements Regulatory Requirement: Importers are required to report to the FDA upon receiving reports or becoming aware of information that indicates that a device marketed by the importer may have caused or contributed to a death or serious injury. The importer must also submit reports of malfunctions to the manufacturer upon obtaining information indicating that a manufacturer’s device has malfunctioned. Purpose or Risk Mitigated: Purpose is to ensure that one additional type of entity that may have information on adverse events is required to make reports. How Does this Fit with Health IT? Applicable/Fits. Need to consider software downloads 23

24 Attorney Client Communication – Privileged and Confidential Subpart E – §§ to.58 – Medical Device Reporting – Manufacturer Reporting Requirements Regulatory Requirement: Manufacturers are required to report to the FDA upon becoming aware of information that indicates that a device marketed by the manufacturer may have caused or contributed to a death or serious injury. The manufacturer must also submit individual adverse event reports, conduct investigations of adverse events and report to the FDA when certain malfunctions occur. Purpose or Risk Mitigated: Purpose is to ensure that manufacturers, which hold primary responsibility for devices, are subject to stringent reporting requirements. How Does this Fit with Health IT? Applicable/Fits. 24

25 Attorney Client Communication – Privileged and Confidential Part 806 – Medical Device Reporting – Reports of Corrections and Removals General Purpose Requires device manufacturers and importers to submit a written report to FDA any voluntary corrections and removals of product from the market within 10 days that were initiated to reduce a risk to health posed by the device Purpose or Risk Mitigated Provides a method for manufacturers and distributors to voluntary take action to protect the public health from products that may present a risk of injury or that may be defective Breakdown Subpart A – General Provisions Subpart B – Reports and Records 25

26 Attorney Client Communication – Privileged and Confidential Subpart B - §§ Medical Device Reporting – Reports of Corrections and Removals Regulatory Requirements Device manufacturers and importers are required to submit a written report to FDA within 10-working days of any correction or removal of a device initiated to reduce risk or health imposed by the device or to remedy a violation. Purpose or Risk Mitigated Provides FDA the visibility of any safety issues that may arise with a product as soon as possible. How does this fit with Health IT? Need to consider practical challenges of recalling software that may be integrated with various other Health IT systems. Need to consider recall conducted through updates that may be installed by users. 26

27 Attorney Client Communication – Privileged and Confidential Subpart B - §§ Medical Device Reporting – Reports of Corrections and Removals Regulatory Requirements If per the regulation, a manufacturer is not required to submit a report to FDA within the 10 working day period, the manufacturer shall keep a record of such a correction or removal with the required information mentioned in this Part. Purpose or Risk Mitigated If FDA need to conduct an audit for a specified reason of the manufacturer, this would provide easy access to such documentation. How does this fit with Health IT? Need to consider updates, bug fixes and routine software support and maintenance 27

28 Attorney Client Communication – Privileged and Confidential Part 807 – Procedures for Device Establishments General Purpose: All owners or operators of establishment that engaged in the manufacturer, preparation, assembly, processing of a device must register and submit lists of its devices in commercial distribution. This section also mandates submission of premarket notifications for certain devices. Purpose or Risk Mitigated: This section is intended to increase disclosure of ownership interests in medical devices and provide the public with information on manufacturers of medical devices. Breakdown: Subpart A – General Provisions Subpart B – Procedures for Device Establishments Subpart C – Procedures for Foreign Device Establishments Subpart D – Exemptions Subpart E – Premarket Notification Procedures How Does this Fit with Health IT? Applicable/Fits but need to consider virtual establishments where there is not one physical location where software is being developed. 28

29 Attorney Client Communication – Privileged and Confidential Subpart E – §§ to.100 – Establishment Registration – Premarket Notification Regulatory Requirement: Devices that are not required to obtain a premarket approval (PMA) must nevertheless make submissions to the FDA, unless exempt. Such submissions must contain information, including a 510k summary, which will allow the FDA to make a finding of substantial equivalence. Purpose or Risk Mitigated: The purpose of this section is to provide an abbreviated procedure for a device not subject to PMA to obtain approval but still provide the FDA with enough information to find that such a device is at least as safe and effective as a legally marketed device. How Does this Fit with Health IT? Need to consider non-high risk Health IT functions fro which there may not be a predicate device. 29

30 Attorney Client Communication – Privileged and Confidential Part 808 – Exemptions From Federal Preemption Of State And Local Medical Device Requirements General Purpose: This part details the preemption of most state regulation of medical devices by the Food, Drug and Cosmetic Act. It also describes the procedures for the submission of applications for exemption from preemption and lists state and local exemptions that are not pre-empted Purpose or Risk Mitigated: The Food, Drug and Cosmetic Act is intended to impose uniform regulation of medical devices throughout the country. The stringent provisions regarding exemptions to preemption for state and local regulations are intended to ensure that the same general scheme is applicable to medical devices regardless of exemption and minimize the effect of state and local differences. Breakdown : Subpart A – General Provisions Subpart B – Exemption Procedures Subpart C – Listing of Specific State and Local Exemptions How Does this Fit with Health IT? Applicable/Fits. 30

31 Attorney Client Communication – Privileged and Confidential Part 809 – In Vitro Diagnostic Products for Human Use Regulatory Requirement: In vitro diagnostic (IVD) products are reagents, instruments, and systems that are intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. Purpose or Risk Mitigated by Regulation: Provides an overview of the IVD submission, manufacture, and labeling process. How Does this Fit with Health IT? Applicable to the extent software is considered an accessory but fit is awkward for stand alone software. 31

32 Attorney Client Communication – Privileged and Confidential Part 810 – Medical Device Recall Authority Regulatory Requirement: If FDA finds that there is a reasonable probability that a medical device could cause serious adverse health consequences or death, the agency may require the manufacturer to cease distribution of the device, instruct professionals to cease the use of the device and require the manufacturer to withdraw the product from the market. Purpose or Risk Mitigated by Regulation: Provides a streamlined process to ensure that all impacted product that could pose risk to patients are accounted for and removed from the market efficiently. How Does this Fit with Health IT? Applicable. 32

33 Attorney Client Communication – Privileged and Confidential Part 812 – Investigational Device Exemptions Regulatory Requirement An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated. Purpose or Risk Mitigated by Regulation: Provides a streamlined process to submit an application for an IDE so that a manufacturer can begin a clinical study in support of a submission. How Does this Fit with Health IT? Need to consider traditional software testing and application of clinical evaluations. 33

34 Attorney Client Communication – Privileged and Confidential Part 814 – Premarket Approval of Medical Devices Regulatory Requirement: Medical devices that require PMAs are Class III products and are considered high risk devices that pose a significant risk of illness or injury, or are devices that are found not substantially equivalent to Class I and II predicate through the 510(k) process. This part provides all requirements to submit a PMA which includes clinical required clinical data. Purpose or Risk Mitigated by Regulation: Provides all requirements to industry to plan for a submission for a Class III product. How Does this Fit with Health IT? Applicable to small subset of Health IT products but would fit as applicable. 34

35 Attorney Client Communication – Privileged and Confidential Part 820 – Quality System Regulation General Purpose: Device manufacturers are required to establish and follow set procedures and policies to help ensure that their products consistently meet set requirements, specifications and are safe and effective. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). How does this fit with Health IT? At high level, QSR is focused on traditional manufacturing and needs to consider application to traditional software development. Most Relevant Sections Subpart B: Management Controls Subpart C: Design Controls Subpart E: Purchasing Controls Subpart J: Corrective and Preventive Action Subpart M: Records Limited or No Application ; , , , , , , , AAMI published report on application of 5 QSR requirements to Health IT 35

36 Attorney Client Communication – Privileged and Confidential Continued Part 820 – Quality System Regulation Breakdown: Subpart A – General Provision An overview of the requirements to create a full quality system and the type of manufacturer this provision applies to. Subpart B – Quality System Requirements Specifies quality system requirements including how to structure the organization. Subpart C – Design Controls Describes the step-by-step process manufactures must implement to develop a medical device. Subpart D – Document Controls Manufactures must develop methods to reviewed, approve and store documents adequately. Subpart E – Purchasing Power Manufacturers must develop a process to ensure that their suppliers, contractors, and consultants maintain quality requirements. Subpart F – Identification and Traceability Manufactures must establish procedures to identify all production, distribution, and installation of products and specifically for surgical implants that support or sustain life by using unit, lot or batch number. Subpart G – Production and Process Controls Manufactures must control the production process to ensure device conforms to device specifications. 36

37 Attorney Client Communication – Privileged and Confidential Continued Part 820 – Quality System Regulation Breakdown : Subpart H – Acceptance Activities Manufacturers must establish procedures to ensure acceptable product or components are being delivered using inspections, tests or other verification tests. Subpart I – Nonconforming Product Manufacturers must establish procedure to control product that does not conform to specified requirements. Subpart J – Corrective and Preventative Action Manufacturers must establish procedures to investigate, capture, and resolve product or other quality issues. Subpart K – Labeling and Packaging Control Manufacturers must establish controlled procedures to develop, change and implement labeling. Subpart L – Handling, Storage, Distribution and Installation Manufacturers must establish procedures to ensure product integrity during the handling, storage, distribution and/or installation of product. Subpart M – Records Manufacturers must establish procedures to maintain all documents related to Part 820. Subpart N – Servicing Manufacturers must establish and maintain instructions and procedures to verify servicing meets specified requirements and proper service reports be generated. Subpart O – Statistical Techniques Manufacturers must establish and maintain procedures for identifying valid statistical techniques for process and product characteristics. 37

38 Attorney Client Communication – Privileged and Confidential Subpart B – 820 – Quality System Regulation – Quality System Requirements Regulatory Requirement: Management with executive responsibility must establish and implement a quality policy which demonstrates the commitment to quality across all levels of the organization and provide an organizational structure that ensures devices are designed and produced according to this quality objective. Purpose or Risk Mitigated by Regulation: Helps prevent faulty devices being generated and reduces the risk of inconsistencies between two identical products. How Does this Fit with Health IT? Applicable/Fits. 38

39 Attorney Client Communication – Privileged and Confidential Subpart C – 820 – Quality System Regulation – Design Controls Regulatory Requirement: Device manufacturers are required to establish and maintain policies and procedures to follow a step by step process called design controls when developing or changing a medical device for class III or II products. Purpose or Risk Mitigated by Regulation: Ensures that product is being developed according to a streamlined process and appropriate checks and balances are occurring throughout the product development cycle so that product issues are captured earlier rather than after it has been developed. How Does this Fit with Health IT? Critical in software development. Need to consider differences between software development and traditional manufacturing and various software development techniques (e.g. Agile). 39

40 Attorney Client Communication – Privileged and Confidential Subpart E – 820 – Quality System Regulation – Purchasing Controls Regulatory Requirement: Device manufacturers are required to establish and maintain policies and procedures that ensure suppliers, contractors, and consultants maintain quality requirements. to follow a step by step process called design controls when developing or changing a medical device for class III or II products. Purpose or Risk Mitigated by Regulation: Ensures that incoming products and components meet quality standards and that the manufacturers have adequate control over the manufacturing process of a given device/component. How Does this Fit with Health IT? Need to consider design transfer. Physical manufacturing requirements do not fit. 40

41 Attorney Client Communication – Privileged and Confidential Subpart J – 820 – Quality System Regulation – Corrective and Preventative Action Regulatory Requirement: Each manufacturer must establish procedures to implement corrective and preventative actions to investigate, capture, and resolve product or other quality issues. Purpose or Risk Mitigated by Regulation: Helps capture product or quality issues quickly, creates a streamlined process to detect such issues and ensures a preventative plan is in place for the future. How Does this Fit with Health IT? Applicable/Fits. 41

42 Attorney Client Communication – Privileged and Confidential Subpart M – 820 – Quality System Regulation – Records Regulatory Requirement: All records that may result from Part 820 must be maintained at the manufacturing establishment or other location that can be accessible by the manufacturer and to FDA. These documents should be readily available for review and copying by the FDA and should be retained for the period of time equivalent to the design and expected life of the product. Purpose or Risk Mitigated by Regulation: Assists FDA during their audits and reviews to determine whether the manufacturing facility and company is operating under an adequate quality system and complies with Part 820. How Does this Fit with Health IT? Consider changes to reflect software development methods. 42

43 Attorney Client Communication – Privileged and Confidential Part 821 – Medical Device Tracking Requirements Regulatory Requirement: The agency requires certain categories of manufacturers to track their medical devices from manufacture through distribution Purpose or Risk Mitigated by Regulation: The purpose of device tracking is to allow certain manufacturers to promptly locate devices in commercial distribution How Does this Fit with Health IT? Not applicable. 43

44 Attorney Client Communication – Privileged and Confidential Part 822 – Postmarket Surveillance Regulatory Requirement Manufacturers may be required to implement postmarket surveillance plans to monitor the safety and effectiveness of products on a continuous basis. Purpose or Risk Mitigated by Regulation: This data provides a larger sample size of uses of a given device and can reveal unforeseen adverse events, the actual rate of anticipated adverse events, or other information necessary to protect the public health. How Does this Fit with Health IT? Unlikely to be applicable but would fit. 44

45 Attorney Client Communication – Privileged and Confidential Part 860– Medical Device Classification Regulatory Requirement: Establishes the criteria and procedures used determining class of regulatory control (class I, class II, or class III) appropriate for particular devices Purpose or Risk Mitigated by Regulation: To ensure consistent application and risk-based classification of medical devices. How Does this Fit with Health IT? Applicable/Fit. 45

46 Attorney Client Communication – Privileged and Confidential Part 861 – Procedures for Performance Standards Development Regulatory Requirement States FDA’s authority to develop special controls for certain medical devices and outlines the content of such guideline. Purpose or Risk Mitigated by Regulation: To ensure safety and effectiveness of certain moderate or high risk medical devices. How Does this Fit with Health IT? Applicable/Fits. 46

47 Attorney Client Communication – Privileged and Confidential Parts Specific Product Classifications Regulatory Requirement Provides a description of various functionality and serves as product classification for the applicable medical device Purpose or Risk Mitigated The product classification identifies which Class, I, II or III the medical device falls into and determines what regulatory requirements apply. How Does this Fit with Health IT? Applicable/Fits. Need to consider additional classifications Clinical Chemistry & Clinical Toxicology 864 Hematology & Pathology 866 Immunology & Microbiology 868 Anesthesiology 870 Cardiovascular 872 Dental 874 Ear Nose & Throat 876 Gastroenterology-Urology 878 General and Plastic Surgey 880 General Hospital & Personal Use 882 Neurological 884 OB/GYN 886 Ophthalmic 888 Orthopedic 890 Physical Medicine 892 Radiology

48 Attorney Client Communication – Privileged and Confidential Part 895 – Banned Devices Regulatory Requirement The Commissioner may initiate a proceeding to designate a device a banned device if the Commissioner finds, on the basis of all available data, which a manufacturer may be required to provide, that the device presents substantial deception or an unreasonable and substantial risk of illness or injury that the Commissioner determines cannot be, or has not been, corrected or eliminated by labeling or by a change in labeling, or by a change in advertising if the device is a restricted device. Purpose or Risk Mitigated by Regulation: The ability to remove product completely from the market that may pose significant risk to human life quickly. How Does this Fit with Health IT? Unlikely to be applicable but would fit. 48

49 Attorney Client Communication – Privileged and Confidential Part 898 – Performance Standard fro Electrode Lead Wires and Patient Cables Regulatory Requirement Wires and cabels that connect to a patietn must meet certain performance standards. Purpose or Risk Mitigated by Regulation: Ensure patient safety in use of wires that connect to the patient. How Does this Fit with Health IT? Not applicable. 49

50 Attorney Client Communication – Privileged and Confidential Big Picture Are there any risks this does not include? Are there any risks associated with Health IT that are not adequately addressed by these FDA requirements? In the aggregate, are the requirements too much? 50


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