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pdfNOTIONAL DRAFT ONLY 04/25/2024
UI Designs & Concepts
CCP-TAP Webform with PRA Considerations
Objective
Create a webform for sponsors to request TAP enrollment.
Requirements
• Display the required PRA language on the first “page”:
⁃ “OMB Control No. 0910-NEW”
⁃ “Expiration date: tbd”
⁃ The following PRA statement (which may be placed with a text box to
help distinguish it from other info, but it doesn’t have to be):
⁃ According to the Paperwork Reduction Act of 1995, an agency
may not conduct or sponsor, and a person is not required to
respond to a collection of information unless it displays a valid
OMB control number. The valid OMB control number for this
information collection is 0910-NEW. The time required to
complete this information collection is estimated to average 15
minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information.
Send comments regarding this burden estimate or any other
aspects of this collection of information, including suggestions for
reducing burden to PRAStaff@fda.hhs.gov.
04/25/2024
Basic Qualifications
CDRH Portal
TAP enrollment request
https:// ccp.fda.gov/prweb/PRAuth/app/default/extsso
Request to enroll in the TAP Pilot
OMB Control No.0910-NEW | Expiration date: tbd | Refer to the PRA Statement for details.
Send your request before 16:00 ET on a business day for us to process it the same day.
Fields are required unless noted as (optional).
Basic qualifications
Device & sponsor information
Review & send to FDA
Basic qualifications
1. Has your proposed device been granted a Breakthrough designation? https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/
Yes (answer for TAP acceptance)
breakthrough-devices-program
No
2. Have you submitted and received feedback through a Pre-Submission
about your device after being granted a Breakthrough designation? https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/
Yes
breakthrough-devices-program
No (answer for TAP acceptance)
3. Is your device early in its device development process (e.g., a pivotal study
has not yet been initiated for the device) at the time of enrollment?
Yes (answer for TAP acceptance)
No
4. Do you already have a device enrolled in the TAP Pilot for the current fiscal https://www.fda.gov/medical-devices/howstudy-and-market-your-device/total-productyear (October 1 - September 30)?
life-cycle-advisory-program-tap
Yes
No (answer for TAP acceptance)
5. Is your device regulated by the Center for Biologics Evaluation and Research
(CBER) or regulated as a combination product?
https://www.fda.gov/combination-products
Yes
No (answer for TAP acceptance)
Cancel request
PB
Save
Next
04/25/2024
PRA Statement Modal
CDRH Portal
TAP enrollment request
https:// ccp.aws.com
Paperwork Reduction Act Statement
According to the Paperwork Reduction Act of 1995, an agency may not
conduct or sponsor, and a person is not required to respond to a collection
of information unless it displays a valid OMB control number. The valid
OMB control number for this information collection is 0910-NEW. The time
required to complete this information collection is estimated to average 15
minutes per response, including the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing the collection of information.
Send comments regarding this burden estimate or any other aspects of this
collection of information, including suggestions for reducing burden to
PRAStaff@fda.hhs.gov.
04/25/2024
Device & Sponsor Information
CDRH Portal
TAP enrollment request
https:// ccp.fda.gov/prweb/PRAuth/app/default/extsso
Request to enroll in the TAP Pilot
OMB Control No.0910-NEW | Expiration date: tbd | Refer to the PRA Statement for details.
Send your request before 16:00 ET on a business day for us to process it the same day.
Fields are required unless noted as (optional).
Basic qualifications
Device & sponsor information
Review & send to FDA
Device & sponsor information
Device information
Q-Submission number
Provide the Q-Submission number under which your
device was granted a Breakthrough Device designation.
Q123456
Product name
Blood Pressure Cuff
Sponsor information
Company name
MedInnovate Solutions Inc.
Address line 1
123 Health Way
Address line 2 (optional)
Suite 456
City
State (US)
MD
MedTech City
Country
United States
Business phone number (optional)
+1-234-432-4224
ZIP/Postal code
78901
Province/region (optional)
Website URL (optional)
https://www.medinnovatesolutions.com
Primary point of contact
First name
Paula
Title (optional)
Regulatory Affairs Specialist
Last name
Bennett
Phone number
+1-222-222-2222
Email address
[email protected]
Cancel request
UN
Save
Next
04/25/2024
Review & Send to FDA
CDRH Portal
TAP enrollment request
https:// ccp.fda.gov/prweb/PRAuth/app/default/extsso
Request to enroll in the TAP Pilot
OMB Control No.0910-NEW | Expiration date: tbd | Refer to the PRA Statement for details.
Send your request before 16:00 ET on a business day for us to process it the same day.
Fields are required unless noted as (optional).
Basic qualifications
Device & sponsor information
Review & send to FDA
Review & send to FDA
The information you entered is shown below. Select the pencil icon to edit it.
Basic qualifications
1. Has your proposed device been granted a Breakthrough designation?
Yes
2. Have you submitted and received feedback through a Pre-Submission
about your device after being granted a Breakthrough designation?
No
3. Is your device early in its device development process (e.g., a pivotal study
has not yet been initiated for the device) at the time of enrollment?
Yes
4. Do you already have a device enrolled in the TAP Pilot for the current fiscal
year (October 1 - September 30)?
No
5. Is your device regulated by the Center for Biologics Evaluation and Research
(CBER) or regulated as a combination product?
No
Device & sponsor information
Device information
Q-Submission number
Q9999999
Product / Trade Name
Blood Pressure Cuff
Sponsor information
Company name
MedInnovate Solutions Inc.
Address
123 Health Way
Suite 456
MedTech City, MD 7901
United States
Business phone number
+1-234-432-4224
Website URL
https://www.medinnovatesolutions.com
Point(s) of Contact
Paula Bennett (primary)
Regulatory Affairs Specialist
UN
+1-222-222-2222
[email protected]
Cancel request
UN
Save
Send
OPTION 1: Simple Submission Confirmation Page
CDRH Portal
TAP enrollment request
https:// ccp.fda.gov/prweb/PRAuth/app/default/extsso
Sent to FDA
You have sent your TAP enrollment request TPR-2024-000000. (Sent on Feb 2, 20XX at 17:10 ET).
+
We will send an enrollment status update within 30 business days. This does not
guarantee an acceptance. Thank you for your interest in the TAP Pilot.
Contact [email protected] if you have any questions or feedback.
You can see the status of your request on the home page once it has been refreshed.
You may close this browser tab.
UN
04/25/2024
| File Type | application/pdf |
| File Modified | 2024-06-24 |
| File Created | 2024-04-26 |