Bill Overview
Title: To allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan.
Description: This bill allows changes to be made to medical devices without the need for supplemental applications or premarket notifications if the changes are made in accordance with a predetermined change control plan.
Sponsors: Rep. Bilirakis, Gus M. [R-FL-12]
Target Audience
Population: People reliant on or using medical devices
Estimated Size: 250000000
- The bill pertains to changes in the regulation of medical devices.
- Manufacturers of medical devices will be directly impacted as they have more flexibility in making changes to existing devices.
- Healthcare providers who use medical devices may be indirectly affected as device updates can occur with less regulatory delay.
- Patients who rely on medical devices for health and treatment will also be impacted, as they may have access to improved devices more quickly due to reduced regulatory burdens.
- The global medical device market and users of these devices will be impacted, which includes a large percentage of the global population owing to the widespread use of medical devices.
Reasoning
- The bill primarily benefits medical device manufacturers as they have reduced regulatory burden, allowing for quicker changes and potentially more innovation.
- The impact on healthcare providers will likely be indirect, as they will have quicker access to updated medical devices, potentially improving patient care.
- Patients may experience improved health outcomes sooner due to faster availability of improved devices.
- The policy has a limited budget that suggests the government expects efficiencies in regulatory processes rather than direct financial investment into devices or their distribution.
- The target population is large as it encompasses anyone who uses medical devices, which is a significant portion of the population.
Simulated Interviews
Medical Device Engineer (California)
Age: 45 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- The policy will drastically reduce our time-to-market for new features.
- It allows us to be more responsive to user feedback and improve devices incrementally.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Surgeon (New York)
Age: 38 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 2/20
Statement of Opinion:
- I hope the changes will improve device reliability.
- The flexibility in updates could mean better outcomes for patients.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Patient with Chronic Illness (Florida)
Age: 60 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- Anything that speeds up improvements in my device is a good thing.
- I'm concerned about the safety checks that might be skipped.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Quality Assurance Specialist in Medical Tech Company (Texas)
Age: 30 | Gender: other
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- The policy minimizes bottlenecks allowing us to ensure quality in other areas.
- I believe the overall safety will not be compromised.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 8 |
Healthcare Policy Analyst (Illinois)
Age: 55 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- This is a double-edged sword; increased speed but with potential risks if not managed carefully.
- Monitoring long-term outcomes will be crucial.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Retired Nurse (Ohio)
Age: 72 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- Patients need timely improvements but safety should never be compromised.
- I'm cautiously optimistic about more rapid updates but concerned about oversight.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 6 | 4 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 7 | 6 |
| Year 20 | 7 | 6 |
Lobbyist for a Medical Device Company (Washington D.C.)
Age: 28 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- This is exactly what we've been pushing for; it's a win for innovation.
- It should lead to cost savings and price reductions.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 9 | 7 |
| Year 3 | 9 | 7 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Healthcare Provider at a Community Clinic (Michigan)
Age: 50 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- Quicker device updates could improve care quality.
- I hope this drives more affordable options for our low-income patients.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Medical Device Sales Representative (North Carolina)
Age: 41 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- This can drive demand as hospitals look to upgrade faster.
- Sales training will need to quickly adapt to device updates.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Consultant for Medical Device Compliance (New Jersey)
Age: 52 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 3/20
Statement of Opinion:
- Much will depend on the details of the control plans and their enforcement.
- It's a boon for smaller companies that can adapt faster.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 8 |
Cost Estimates
Year 1: $50000000 (Low: $30000000, High: $70000000)
Year 2: $52000000 (Low: $31000000, High: $73000000)
Year 3: $54000000 (Low: $33000000, High: $76000000)
Year 5: $58000000 (Low: $36000000, High: $81000000)
Year 10: $70000000 (Low: $43000000, High: $97000000)
Year 100: $-1 (Low: $-1, High: $-1)
Key Considerations
- The bill facilitates innovation by reducing regulatory delays, potentially accelerating market access for advanced medical devices.
- Flexibility in modifying devices could support manufacturers' competitiveness, particularly in an evolving technology landscape.
- Patient safety and efficacy must be preserved despite reduced oversight, a consideration for potential risks.
- Impact on the FDA's workload and how it reallocates resources in response to reduced premarket submissions.