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United States Food and Drug Administration Generic Clearance: Customer Satisfaction Surveys
OMB Control Number 0910-0360 Gen IC Request for Approval
Title of Gen IC: CDRH Advisory Committee Satisfaction Survey
    1. Statement of Need
It is a continued strategic priority for the Center for Devices and Radiological Health (CDRH) to Provide Excellent Customer Service. The center has in place “Standards of Excellence” to assure CDRH employees understand and interact with our stakeholders with those standards in mind.
The CDRH Advisory Committee team needs a tool to gather satisfaction levels of our meeting participants/stakeholders both inside FDA/CDRH and external, including the medical device industry, academia, patient groups, health professionals, consumers and anyone that interacts with CDRH. This voluntary Satisfaction Survey enables CDRH to: (1) determine stakeholder satisfaction ratings; (2) identify and help monitor trends around specific areas of satisfaction or dissatisfaction; and (3) identify areas for process improvement and improve them.

    2. Intended Use of the Information

CDRH plans to use the data collected to: (1) determine customer satisfaction ratings; (2) identify and monitor trends around specific areas of satisfaction or dissatisfaction and determine future actions needed for advisory committee meetings; and (3) identify areas for process improvement and improve them so stakeholders receive the service they expect from CDRH. We plan to separate the data by stakeholder and examine to determine the satisfaction of our stakeholders.
    3. Description of Respondents

Respondents take the survey voluntarily and include stakeholders both internal and external to CDRH/FDA—the medical device industry, academia, patient groups, health professionals, consumers, other federal agencies and anyone else that interacts with CDRH and wants to provide feedback about our advisory committee meetings via the survey tool.

    4. How the Information is Collected

The information is electronically collected using an electronic survey instrument (Survey Monkey). Links to the survey may be made available on https://www.fda.gov/advisory-committees/recently-updated-advisory-committee-materials, on advisory committee meeting agendas and materials, email to stakeholders, and added to CDRH Presentations made during advisory committee meetings.

    5. Confidentiality of Respondents

No requests for personal information (names, email address, phone numbers, etc.) are made through this survey. In addition, CDRH will include the following statement on the survey instrument and/or instructions:

“Your participation / nonparticipation is completely voluntary, and your responses will not affect your eligibility to receive any FDA services. In instances where respondent identity is needed
(e.g., for follow-up of non-respondents), this information collection fully complies with all aspects of the Privacy Act and data will be kept private to the fullest extent allowed by law.”

    6. Amount and Justification for Proposed Incentive

None

    7. Questions of a Sensitive Nature

None

    8. Description of Statistical Methods

Data analytics include the “out of the box” survey monkey statistics. In addition, data is exported to excel. Excel files will be analyzed manually.

    9. Burden

Based on anticipated participation, CDRH anticipates receiving about 2,000 surveys a year, approximately 40% of the responses are from CDRH employees. The survey takes 3-5 minutes to complete (100 burden hours/year).  There are 15-20 CDRH Advisory Committee meetings per year with approximately 100 participants per meeting.

Type of information collection/Category of Respondent
No. of Respondents
Participation Time (minutes)
Total Burden (hours)
Individuals or households, Local, State, Tribal, or Federal Government, Medical Device Industry, Academia, Patient Groups, Health Professionals, Consumers
1,200
5 (.08)
100

    10. Date(s) to be Conducted

February 2024 to December 2027

    11. Requested Approval Date

February 2024

    12. FDA Contacts

Program Office Contact
FDA PRA Contact
 Abigail Corbin 
(CDRH-PRA Team) [email protected] 301-796-9142

Sharon Davis (OCE) [email protected] 301-796-5717
FDA CENTER: Center for Devices and Radiological Health (CDRH)
JonnaLynn Capezzuto, Director
Paperwork Reduction Act Staff
Office of Enterprise Management Services Office of Operations
[email protected]
301-796-3794