Bill Overview
Title: Emerging Signals Modernization Act of 2022
Description: This bill establishes certain requirements relating to the Food and Drug Administration's (FDA's) public notices on the potential new risks of approved medical devices (i.e., emerging signals), including with respect to the standards of evidence needed for such notices. The FDA must update its current guidance on emerging signals to align with the bill's requirements.
Sponsors: Rep. Guthrie, Brett [R-KY-2]
Target Audience
Population: Users of FDA-approved medical devices
Estimated Size: 66000000
- The bill involves the FDA, which impacts medical devices. Therefore, the primary impacted population will be users of medical devices.
- Medical device users number in the hundreds of millions worldwide, as such devices include things like insulin pumps, pacemakers, and other critical health equipment.
- The global population with chronic diseases or conditions requiring medical devices is large.
- In the US alone, a significant portion of the population uses medical devices regularly, due to high prevalence of conditions like diabetes and heart diseases.
- The FDA's updates to emerging signals guidance mean changes will affect how medical risks are communicated and managed, critical for patient safety.
Reasoning
- The target population consists of users of FDA-approved medical devices in the U.S. These include individuals with chronic diseases, which is estimated to be over 66 million in the American context.
- The policy's budget must cover updating guidelines without exceeding its fixed amount, impacting thousands to millions of users indirectly, primarily through ensuring safer devices and better communication of risks.
- Most impacted individuals will likely see changes in their wellbeing scores due to increased safety or communication, though levels of impact will vary based on dependence on these devices.
- The policy might directly decrease the incidence of adverse medical events by improving signal communication, thus affecting long-term wellbeing.
Simulated Interviews
retired (Arizona)
Age: 65 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- I think better communication about medical device risks can really help me manage my health more effectively.
- Knowing sooner when there's a potential issue with my device can help me talk to my doctor and decide what to do next.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 5 |
| Year 10 | 9 | 5 |
| Year 20 | 9 | 5 |
software engineer (California)
Age: 48 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- Clearer FDA communications will reduce anxiety about my pacemaker.
- Timely updates can help ensure my safety and reliability of the device.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 5 |
financial analyst (New York)
Age: 30 | Gender: male
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- Enhanced guidelines will hopefully lead to fewer device malfunctions.
- Feeling more secure about my insulin pump's reliability would be reassuring.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 9 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 7 |
| Year 20 | 8 | 6 |
teacher (Texas)
Age: 55 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 3.0 years
Commonness: 3/20
Statement of Opinion:
- I hope the new rules will mean faster communication from my doctor about device issues.
- It's important to me that any risk signals are managed promptly.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 6 |
freelancer (Florida)
Age: 40 | Gender: other
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 2/20
Statement of Opinion:
- Knowing the potential risks early helps me feel in control of my situation.
- I appreciate any information that might assist in my hearing journey.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 8 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 7 | 5 |
retired doctor (Ohio)
Age: 70 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 15.0 years
Commonness: 3/20
Statement of Opinion:
- The updates could mean more limited disruptions if issues are flagged early.
- This gives me some peace of mind about unexpected device failures.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 5 |
| Year 10 | 9 | 4 |
| Year 20 | 8 | 3 |
grad student (Georgia)
Age: 29 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 2.0 years
Commonness: 2/20
Statement of Opinion:
- Ensuring any emerging risks are communicated helps me plan for my future.
- I am optimistic that improved FDA guidelines will have broader health benefits.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 6 |
construction worker (New Mexico)
Age: 33 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 1.0 years
Commonness: 4/20
Statement of Opinion:
- The policy might ensure I get more timely information about my hearing aid's issues.
- I'd feel better equipped to make choices about my health in noisy environments.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 5 |
chef (Illinois)
Age: 60 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 4.0 years
Commonness: 6/20
Statement of Opinion:
- I hope the policy will mean fewer device recalls and better action plans.
- Peace of mind about my medical device options is important for my overall health.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 7 | 5 |
retired teacher (Washington)
Age: 72 | Gender: other
Wellbeing Before Policy: 7
Duration of Impact: 1.0 years
Commonness: 2/20
Statement of Opinion:
- Better updates about medical devices are always welcome in the senior community.
- Increasing transparency about device issues can reduce stress and worry.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 6 | 5 |
Cost Estimates
Year 1: $25000000 (Low: $15000000, High: $35000000)
Year 2: $26000000 (Low: $16000000, High: $36000000)
Year 3: $27000000 (Low: $17000000, High: $37000000)
Year 5: $29000000 (Low: $19000000, High: $39000000)
Year 10: $32000000 (Low: $22000000, High: $42000000)
Year 100: $50000000 (Low: $35000000, High: $65000000)
Key Considerations
- The cost of updating and maintaining the guidance system at the FDA.
- The need for efficient inter-departmental coordination to update guidance without hampering ongoing activities.
- Long-term monitoring and potential updates to other associated regulations and technologies.