Bill Overview
Title: CLEAR Documentation Act
Description: This bill establishes certain rules for the Food and Drug Administration to issue export certifications for medical devices that are manufactured outside of the United States. A certification for a medical device must be subject to a user fee.
Sponsors: Sen. Cassidy, Bill [R-LA]
Target Audience
Population: Individuals relying on medical devices subject to export certifications
Estimated Size: 300000
- The bill affects medical device manufacturers, particularly those involved in exporting devices manufactured outside the United States.
- It primarily impacts the manufacturers as it establishes rules for issuing export certifications and requires a user fee for these certifications.
- The bill's impact extends to the healthcare sector, as it deals with medical devices.
- End users of these medical devices, such as hospitals and clinics worldwide, may indirectly feel the impact due to possible changes in device availability or costs.
Reasoning
- The policy directly impacts medical device manufacturers who need export certifications, as it introduces user fees and new rules for exporting devices made outside the U.S.
- Given the focus on medical devices, healthcare providers and consumers may experience indirect effects, such as changes in device cost or availability.
- Budget constraints imply careful selection of who gets affected most, particularly manufacturers more reliant on overseas operations.
- Healthcare consumers (patients) are moderately common but less directly impacted as immediate focus is on manufacturers and major distributors.
Simulated Interviews
Medical Device Manufacturer Executive (California)
Age: 45 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- The user fees for certifications may strain our budget, affecting R&D investments.
- Long term, it could standardize and streamline our export processes.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 6 | 7 |
| Year 3 | 5 | 7 |
| Year 5 | 6 | 7 |
| Year 10 | 7 | 8 |
| Year 20 | 7 | 8 |
Healthcare Consultant (Illinois)
Age: 30 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 5.0 years
Commonness: 8/20
Statement of Opinion:
- Hospitals may face increased costs if manufacturers pass on user fees.
- Clearer certification processes can benefit procurement by reducing uncertainties.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 8 |
| Year 2 | 7 | 8 |
| Year 3 | 7 | 9 |
| Year 5 | 8 | 9 |
| Year 10 | 8 | 9 |
| Year 20 | 8 | 9 |
Regulatory Affairs Specialist (Michigan)
Age: 55 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- Additional rules may add to regulatory load initially, but lead to streamlined processes.
- The user fee could be a minor impediment compared to the clarity gained.
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 | 7 | 7 |
| Year 20 | 7 | 7 |
Medical Equipment Sales Representative (North Carolina)
Age: 28 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 7/20
Statement of Opinion:
- Export certification rules may initially disrupt sales patterns.
- In the long run, might provide more predictable export timelines.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 8 |
| Year 3 | 7 | 8 |
| Year 5 | 8 | 8 |
| Year 10 | 8 | 9 |
| Year 20 | 8 | 9 |
CEO of a Small Medical Device Start-up (Texas)
Age: 50 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 15.0 years
Commonness: 4/20
Statement of Opinion:
- Increased fees may slow our ability to scale and compete internationally.
- However, clearer certification might simplify planning and reduce export chaos.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 4 | 5 |
| Year 2 | 5 | 5 |
| Year 3 | 5 | 5 |
| Year 5 | 6 | 6 |
| Year 10 | 6 | 6 |
| Year 20 | 7 | 7 |
Clinical Researcher (New York)
Age: 42 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- Policy shifts might limit the availability of some devices for research.
- Long term, may drive innovation and quality due to tighter standards.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 6 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 8 |
Retired Healthcare Administrator (Florida)
Age: 60 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 8.0 years
Commonness: 8/20
Statement of Opinion:
- Any increase in device cost could affect retirees on fixed incomes.
- Hopeful that standardized certification will enhance quality control.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 7 | 7 |
| Year 10 | 7 | 7 |
| Year 20 | 7 | 7 |
Supply Chain Manager for a Medical Device Company (Washington)
Age: 35 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- Higher export costs might lead to supply chain adjustments and optimization challenges.
- A standardized process could improve predictability in the long run.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 8 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 8 |
Patient Care Advocate (Oregon)
Age: 25 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 8.0 years
Commonness: 10/20
Statement of Opinion:
- Any cost increases could affect access for our patients who need these devices.
- Better standards and export processes might improve device reliability.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 7 |
| Year 2 | 6 | 7 |
| Year 3 | 7 | 8 |
| Year 5 | 7 | 8 |
| Year 10 | 8 | 8 |
| Year 20 | 8 | 8 |
Healthcare Policy Analyst (Massachusetts)
Age: 39 | Gender: other
Wellbeing Before Policy: 8
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- It's crucial for these certifications to aid efficiency rather than burden costs excessively.
- Longterm, could push the industry toward more local manufacturing, worth monitoring closely.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 8 | 8 |
| Year 3 | 8 | 9 |
| Year 5 | 8 | 9 |
| Year 10 | 9 | 9 |
| Year 20 | 9 | 9 |
Cost Estimates
Year 1: $5000000 (Low: $4000000, High: $6000000)
Year 2: $5000000 (Low: $4000000, High: $6000000)
Year 3: $5200000 (Low: $4200000, High: $6200000)
Year 5: $5500000 (Low: $4500000, High: $6500000)
Year 10: $6000000 (Low: $5000000, High: $7000000)
Year 100: $10000000 (Low: $8000000, High: $12000000)
Key Considerations
- The bill affects a notable segment of the medical device industry focused on exports.
- European and Asian markets are significant importers of U.S. medical device technology, requiring strategic handling of the certification process.
- There may be legal challenges from the industry regarding the imposition of user fees.
- The long-term impact hinges on efficient implementation and administration by the FDA.