Procedure: The Breakthrough Devices Program
Country: United States
Version #: 01/18/2024
Author: Vlad Reznikov
Editor: Daria Kostiuchenko

                                                                 

ID: US-MD-BDP-SR
Category: Medical Devices
Validity: Until 510(k), PMA or De Novo Application
Certified by: Vlad Reznikov
Copyright: Pattern of USA Inc.
                                                            

SUMMARY

The Breakthrough Devices Program (BDP) replaces the Expedited Access Pathway and Priority Review in the form of Q-Sub (Q-Submission or Pre-submission). The Breakthrough Devices Program allows us to request formal FDA feedback on the medical device registration process before we make a move to submit a 510(k), PMA, or De Novo marketing authorization. This could be done in written and/or Q-Sub meeting online or on-site depending on FDA recommendation. No official charges are posted, and it takes between 30-60 days for a response following the FDA letter. The positive Breakthrough Devices Program conclusion prioritizes and expedites all FDA processes for market authorization, aiming to accelerate the availability of innovative medical devices or diagnostics.                                  

Us Medical Devices The Breakthrough Devices Program Simplified Regulations Card Gantt Chart (1) Page 0001 (1)

Must-Have Requirements, Recognized Standards, and Certifications:                                                               

  • POA
  • Questions, Suggestions and Proposals
  • Information to describe the device
  • The proposed indication for use                                      
  • Regulatory history
  • What type of marketing submission do we plan to submit to the FDA for the devi

Nice-to-have:

  • BDP Statutory criteria allocation
  • R&D studies and documents
  • MAs in other countries
  • Planned Type of MA submission
  • Authorized Representative see GP-PhR-AR-SR card                               

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

Implementation Period: Immediately                                                                  

Deliverables: FDA letter

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

BDP Preparation (documents and data assembling)

MAH

week 5

2

    

  I.2

Requesting Q-submission feedback from FDA

Executor

week 7

1

    

  I.3

Communication with NRA

Executor

week 8

4

    

  I.4

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

Executor

week 12

2

    

  I.5

Conducting the pre-submission meeting if so

Executor

week 14

2

    

  I.6

Follow-up and further discussions

Executor

week 16

1

   

FDA Letter

F

Final Phase In-house Post-Authorization Activity

       

  F.1

Service Acceptance Certificate Signing

MAH

week 17

1

    

  F.2

Final Invoice

Executor

week 17

1

    

  F.3

Final Payment

MAH

week 18

1

    

  F.4

Contract Termination

Executor

week 18

1

    

  F.5

Archiving and limiting access

Executor

week 19

1

   

Archiving

 

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