Procedure: Q-Sub Activities
Country: Global Procedure
Version #: 01/03/2024
Author: Daria Kostiuchenko
Editor: Daria Kostiuchenko

                                                                 

ID: GP-MD-QSA-SR
Category: Medical Devices
Validity: Until MA Application
Certified by: Vlad Reznikov
Copyright: Pattern of USA Inc.
                                                            

SUMMARY

Q-Submission (Q-Sub) refers to the important opportunities for submitters to share information with NRA and receive input outside of the submission of an feedback prior to an intended premarket submission of IDE, PMA, HDE, De Novo request, 510(k), Dual, BLA, IND. The interactions tracked in the Q-Sub program may be used at different points along the total product life cycle for a device and are voluntary. There are several Q-Sub types: Pre-Submission, Submission Issue Request (SIR), Study Risk Determination, Informational Meeting.                                         

Gp Medical Devices Q Sub Activities Simplified Regulations Card Gantt Chart (1) Page 0001

Must-Have Requirements, Recognized Standards, and Certifications:                                                               

  • POA                                                                  
  • Questions, Suggestions and Proposals  

Nice-to-have:

  • Regulatory Intelligence Report see GP-PhR-RI-SR card
  • R&D studies and documents
  • Authorized Representative see GP-PhR-AR-SR card
  • MAs in other countries                                      

Typical Gaps and Deficiencies: Incomplete or insufficient data, unprepared meetings and communications with NRA                                                     

Implementation Period: Immediately                                                                  

Deliverables: NRA Advise

PHASE

TASK

TASK

START

DURATION

 

Fee

 

KPI

NUMBER

TITLE

OWNER

W/M/Q/Y

in weeks

3rd Party 

Service 

State

 

0

In-house Pre-Submission Activity

       

  0.1

NDA signing or validation

Executor

week 1

1

    

  0.2

Contract Closing

MAH

week 1

1

    

  0.3

POA issuance and shipping

MAH

week 1

1

    

  0.4

Invoice is sent to MAH and paid

Executor

week 1

1

    

  0.5

Document processing

Executor

week 2

1

    

  0.6

Translations, Notary, and Apostilles 

3rd party

week 2

2

    

  0.7

SOW is approved by MAH

Executor

week 4

1

   

Application

I

Q-Sub Feedback Request

       

  I.1

Q-Sub Preparation (documents and data assembling)

MAH

week 5

2

    

  I.2

Requesting pre-submission feedback from NRA

Executor

week 7

1

    

  I.3

Communication with NRA

Executor

week 8

2

    

  I.4

Scheduling pre-submission meeting (online or in-person)

Executor

week 10

2

    

  I.5

Conducting the pre-submission meeting if so

Executor

week 12

2

    

  I.6

Follow-up and further discussions

Executor

week 14

1

   

Decision or Q&A

F

Final Phase In-house Post-Authorization Activity

       

  F.1

Service Acceptance Certificate Signing

MAH

week 15

1

    

  F.2

Final Invoice

Executor

week 16

1

    

  F.3

Final Payment

MAH

week 17

1

    

  F.4

Contract Termination

Executor

week 18

1

    

  F.5

Archiving and limiting access

Executor

week 18

1

   

Archiving

 

Feel free to submit a Request for Proposal (RFP) for a specific country or territory to info@patternofusa.com