Regulations Subgroup Plan
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Work product of EBG for review and discussion by the FDASIA Regulation Subgroup; May not reflect the subgroup’s views
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REGULATIONS SUBGROUP PLAN
June 14,2013
Work product of EBG for review and discussion by the FDASIA Regulation Subgroup; May not reflect the subgroup’s views
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Regulations Subgroup Plan
•For June, take each of the three agencies and study their regulatory requirements applicable to HIT
Work product of EBG for review and discussion by the FDASIA Regulation Subgroup; May not reflect the subgroup’s views
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Roadmap—FDA Example
1. Exercise Overview 2. Health IT Use Case 3. Themes regarding HIT4. FDA Device Regulatory Framework5. Big Picture Assessment
Work product of EBG for review and discussion by the FDASIA Regulation Subgroup; May not reflect the subgroup’s views
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To be clear, what does FDA regulate?Listed in order moving away from the patient.1. “Classic” medical devices that accomplish a diagnostic or therapeutic purpose
through touching the patient. E.g. Pacemakers Monitors Infusion pumps Operating tables and wheelchairs
2. In vitro diagnostic devices that work on human specimens Lab equipment Point of care or home diagnostics like blood glucose or INR
3. HIT connective tissue MDDS—retrieve, store, display, convert data from devices—but not analyze, because that
typically triggers a higher level of regulation! LIS
4. Certain standalone software CAD CDS, drug reminders, calculators, certain cancer treatment analytics EHR—could but presently choosing not to
HIT unregulated by FDA• General purpose network
• Scheduling software
Work product of EBG for review and discussion by the FDASIA Regulation Subgroup; May not reflect the subgroup’s views
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Existing FDA Regulation, visually speaking
Certain Standalone HIT
HIT Connective Tissue
IVDs
Classic Device
Non FDA-regulated HIT
Work product of EBG for review and discussion by the FDASIA Regulation Subgroup; May not reflect the subgroup’s views
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Exercise Overview
• Identifying example Health IT Use Cases • 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
Work product of EBG for review and discussion by the FDASIA Regulation Subgroup; May not reflect the subgroup’s views
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Health IT Use Cases
• Identify uses cases that help assess the suitability of the FDA regulatory approach• Consider
• mechanical ventilation weaning• A lower acuity use such as mobile health• One that presents interoperability issues• Perhaps PCA based on AAMI
work--http://ppahs.wordpress.com/2012/02/01/guest-post-yes-real-time-monitoring-would-have-saved-leah-2/
Work product of EBG for review and discussion by the FDASIA Regulation Subgroup; May not reflect the subgroup’s views
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Themes in HIT1. HIT role in systems
a. Open-ended intended use (don’t know what will be part of the system), so it is more difficult to assess risk.
b. Product failure investigation. It is difficult to figure out what went wrong, and thus who has regulatory responsibility
2. The boarder between FDA-regulated products/software and non-FDA-regulated software.
3. The fact that end-users routinely modify software significantly. What is that – manufacturing or use?
4. The virtual manufacturing process for software.5. The virtual nature of the product itself, when it comes to labeling and
other requirements6. The different model for purchasing software, available over the
Internet for download 7. The need to constantly update software
Work product of EBG for review and discussion by the FDASIA Regulation Subgroup; May not reflect the subgroup’s views
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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.
• What about intended uses that evolve over time?• How does FDA cope with interoperable software where the whole system is not
defined at the time of market introduction?• How does the use of SDKs and APIs by 3rd parties impact a product’s intended
use? Does the 3rd party product impact the intended use?• How do claims of compatibility by one manufacturer impact the other product’s
intended use? What data are needed to support such claims? How are claims maintained as either product is updated?
Work product of EBG for review and discussion by the FDASIA Regulation Subgroup; May not reflect the subgroup’s views
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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
• AAMI published report on application of 5 QSR requirements to MDDS http://www.aami.org/publications/AAMINews/May2012/sw87.html
• AAMI is now working on a broader project for HIT
Work product of EBG for review and discussion by the FDASIA Regulation Subgroup; May not reflect the subgroup’s views
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These sections have Limited or No Application• Subpart F--Identification and Traceability • § 820.65 - Traceability.
• Subpart G--Production and Process Controls • § 820.70 - Production and process controls. • § 820.72 - Inspection, measuring, and test equipment. • § 820.75 - Process validation.
• Subpart H--Acceptance Activities • § 820.80 - Receiving, in-process, and finished device acceptance. • § 820.86 - Acceptance status.
• Subpart I--Nonconforming Product • § 820.90 - Nonconforming product.
• Subpart K--Labeling and Packaging Control • § 820.130 - Device packaging.
• Subpart L--Handling, Storage, Distribution, and Installation • § 820.150 - Storage.
Work product of EBG for review and discussion by the FDASIA Regulation Subgroup; May not reflect the subgroup’s views
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21 CFR Chapter 1
21 CFR Chapter 1: FDA, Subchapter H: Medical Devices Applies? 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
862-892 Specific Product Classifications
895 Banned Devices Low likelihood
898 Performance Std For Electrode Lead Wires And Patient Cables N/A
Work product of EBG for review and discussion by the FDASIA Regulation Subgroup; May not reflect the subgroup’s views
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Big Picture--JulyFor each of the three agencies, and considering the work of the safety and innovation subgroup, with regard to the studied regulatory requirements, ask:1. Are there any risks associated with Health IT that are
not adequately addressed by these requirements?2. In the aggregate, considering the risks, are the
requirements too much and narrowly focused on the risks?
3. Have the needs for innovation been adequately protected?
4. Is there a better way to regulate these risks?
Work product of EBG for review and discussion by the FDASIA Regulation Subgroup; May not reflect the subgroup’s views
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Bigger picture
Looking at the three agencies all together and the overall level of risk and needs for innovation, • Consider and prioritize lists of
Key ambiguities in the three regulatory schemesAreas of duplication among the three agenciesChanges in specific regulatory requirements needed
to address safety or innovation
Work product of EBG for review and discussion by the FDASIA Regulation Subgroup; May not reflect the subgroup’s views
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Biggest picture
• Looking at the three agencies together, is there a better way to regulate HIT?
Work product of EBG for review and discussion by the FDASIA Regulation Subgroup; May not reflect the subgroup’s views
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Development of final work product
• Regulatory specs, a prioritized list of--Big picture goals for the agency as they consider revisionsAreas of duplication that need to be resolvedRegulatory elements that need to be changed, and why
(goals for the change)Ambiguous elements that need to be clarified
Work product of EBG for review and discussion by the FDASIA Regulation Subgroup; May not reflect the subgroup’s views
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DISCUSSION
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