Procedure: Pre-market Notification 510(k)
Country: United States
Version #: 01/12/2024
Author: Daria Kostiuchenko
Editor: Daria Kostiuchenko

                                                                 

ID: US-MD-PMN-SR
Category: Medical Devices
Validity: Change, withdrawn, or FDA update
Certified by: Vlad Reznikov
Copyright: Pattern of USA Inc.
                                                            

SUMMARY

Every company who wants to sell a Class I, Class II, or even Class III device (may be applicable for novel devices with lower risk profiles) intended for human use in the US, and does not require a prior application for approval (PMA), must submit a 510(k) to the FDA, unless the device is exempt from the 510(k) requirement under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Comprehensive 510(k) submission information about the device, its intended use, scientific and technical data, and a comparison to the predicate device. To ensure compliance, the 510(k) application should be filed at least 90 days before the device is offered for sale, regardless of whether it was still in development or undergoing clinical trials prior to that date. 
In cases where there are changes or modifications made to a device that has already been legally sold, and these changes could significantly impact its safety or performance, the holder of the 510(k) must assess whether the modification will have a significant effect on the device’s safety or efficacy. Any changes should be made in accordance with the quality system regulation, 21 CFR 820, and should be documented in the device master record and change control records.                

Us Medical Devices Premarket Notification 510(k) Simplified Regulations Card Gantt Chart Page 0001

Must-Have Requirements, Recognized Standards, and Certifications:                                                               

  • Technical documentation, i.e. MDR/IVDR
  • Risk assessments                                              
  • Substantial Equivalence predicate device

Nice-to-have:

  • Labeling
  • Regulatory Compliance and Gap Analysis see GP-PhR-GAP-SR card
  • Regulatory Intelligence and Strategic Consulting see GP-PhR-RI-SR card

Typical Gaps and Deficiencies: Understand the regulatory pathway and requirements applicable to the device. Incorrect predicate device selection. Inadequate documentation. Rush in submitting the 510(k) without being prepared                                            

Implementation Period: within 90 days                                                           

Deliverables: FDA clearance letter ref. Pre-market Notification 510(k) (PMN), FDA listing

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

SOW is approved by MAH

MAH

week 1

1

   

SOW

  0.4

POA issuance and shipping

MAH

week 2

1

    

  0.5

Invoice is sent to MAH and paid

Executor

week 3

1

   

POP

I

Review

       

  I.1

Predicate device equivalence, admin. & info set review

Executor

week 4

1

    

  I.2

PMA and 510(k) exemption review

Executor

week 5

1

    

  I.3

Technical Documentation review vs. FDA requirements

Executor

week 6

2

    

  I.4

Defining 3P510k or FDA 510(k) pathway

Executor

week 8

1

   

Report

II

Studies

       

  II.1

Сonducting technical, toxicology, electrical, and software tests, as well clinical and suitability studies, if advised

Executor

week 9

4

   

Reports

III

Application and Evaluation

       

  III.1

510(k) Application prep

Executor

week 13

2

    

  III.2

FDA payment 

MAH

week 15

1

    

  III.3

Submission of 510(k) Application

Executor

week 16

1

    

  III.4

Approval (Skip Ph.III) or Query (GoTo Ph.III)

NRA

week 17

8

   

Approval or Q&A

IV

Q&A

       

  IV.1

Analysis and addressing Qs to MAH

Executor

week 25

1

    

  IV.2

Answering with relevant documents

MAH

week 26

1

    

  IV.3

Official Response Evaluation

NRA

week 27

4

    

  IV.4

Approval (GoTo Ph.IV) or Query (Rpt. Ph.III)

NRA

week 31

1

   

Approval or Q&A

V

Approval

       

  V.1

FDA Letter

NRA

week 32

1

   

Approval

  V.2

FDA Conclusion publication

NRA

week 33

1

   

Publication

  V.3

FDA Listing

Executor

week 34

1

   

Listing

  V.4

Reporting to MAH

Executor

week 34

1

   

Report

F

Final Phase In-house Post-Authorization Activity

       

  F.1

Service Acceptance Certificate signing

MAH

week 35

1

    

  F.2

Final Invoice

Executor

week 35

1

    

  F.3

Final Payment

MAH

week 35

1

    

  F.4

Contract Termination

Executor

week 36

1

    

  F.5

Archiving and limiting access

Executor

week 37

1

   

Archiving

 

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