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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

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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

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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

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Existing FDA Regulation, visually speaking

Certain Standalone HIT

HIT Connective Tissue

IVDs

Classic Device

Non FDA-regulated HIT

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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

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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/

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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

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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?

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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

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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.

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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

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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?

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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

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Biggest picture

• Looking at the three agencies together, is there a better way to regulate HIT?

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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

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DISCUSSION