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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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HF PAS


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General
Study Status Protocol Pending
Application Number H190001 / PAS002
Study Name HF PAS
General Study Protocol Parameters
Study Design Active Surveillance
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objectives of the summative usability evaluation are to:

1. Demonstrate that the device can be used by representative intended users under simulated and actual use conditions, without producing patterns of failures that could result in a negative clinical impact to patients or harm to users or patients;

2. Demonstrate that the device design, representative training and labeling are effective in mitigating all use-related risks to an acceptable level;

3. Demonstrate that no new use-related hazards or hazardous scenarios have emerged, and evidence supports that benefits outweigh the residual use-related risks; and

4. Demonstrate that operators are able to prepare the solvent mixture correctly, including verification of the mixture.
Study Population Description 1. Age: 18+ years old

2. Gender: Male or Female

3. Education: Undergraduate degree

4. Experience: unrestricted

5. Primary Duties: Performs laboratory procedures, including preparing and testing specimens and recording results

6. Training: on-the-job instrument training, aseptic technique, blood/plasma handling procedure

7. Hearing: unrestricted

8. Vision: corrected vision or no impairments

9. Permissible impairments: appropriate to the job

10. Language: English

11. Cultural Background: unrestricted
Sample Size The sample will consist of trained HDL Therapeutics professionals, N=5.
Data Collection The summative usability study data collection and analysis is intended to provide sufficient and appropriate data to facilitate identification and understanding of the root causes of any use failures or problems that occur, including usability issues. The root cause analysis is intended to identify causes that are related to the design of the system, the system labeling (including IFU), and the training of test participants. Only the completion of the task without any observed use difficulties, use errors, or assistance from the moderator will be deemed a successful outcome. All other outcomes will be considered degrees of failure for which the moderator will observe and report the nature of the issues in greater detail. A failure can be classified as any assistance provided by the moderator to a test participant for any specific task, beyond what is provided during the training session. A failure can also result if the participant performs a task incorrectly and does not request help. The acceptable range for the number of attempts for this system is three. There will be a limit of 3 times a participant can attempt a task.
Follow-up Visits and Length of Follow-up The follow-up will be immediately after the 8 hour training evaluation.


HF PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 12/01/2021    
18 month report 06/01/2022    
two year report 12/01/2022    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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