FDA 510k





Wanted to sell your product in United States? Register your establishment and List the Medical Device prior to launch.

One moment… There are three condition for listing

Condition 01 - Premarket approval (PMA)

Condition 02 - 510(k) Clearance order.

Condition 03 - Device exempt from 510(k)

FDA 510k is a premarket submission made to United States Food and Drug Administration, that the medical device to be marketed is safe and effective, by proving it is substantially equivalent to a legally marketed medical device.

QARA consultants guide you completely from planning to File submission through US Agent and coordination with FDA during file review. Our Online service is accepted by medical device manufacturers worldwide. It is fast and economic!!!

THE BEST WAY TO SUCCESSFULLY SUBMIT 510k NOTIFICATION

APPOINT QARA to make your submission FAST and ERROR FREE.

QARA special feature allows the client to interact with QARA team face to face on Skype/G-talk, for project planning, device testing, validations, predicate device identification and other scientific and technical issues on day to day basis till the project completion.

Assume our team is with your team till project completion.

No matter where YOU are OR where WE are....

Contact us to get started.





 

QARA – The process of 510k

The below table is only for indication purpose

 

Stages Activity Responsibility Duration Cost Involved
Step 01 Identify the device Client NA  
Step 02 Identify the models and variants. Client NA  
Step 03 Appoint consultant.        Client 7 Days Non invasive Devices 12000 USD
All Invasive devices 15500 USD
Non Invasive Electromagnetic device 12000 USD
Electromagnetic Devices 10500 USD
Step 04 Determination of Intended use Client 45-90 Days
Step 05 Identify of product code and Regulation Number.  Consultant
Step 06 Identify Predictive Device.  Consultant  + Client
Step 07 Get device Guidance from FDA Consultant
Step 08 Determination of 510(k) Type Consultant
Step 09 Content creation for Traditional or Abbreviated 510k Consultant
Step 10 Identify national and international standards Consultant + Client
Step 11 Suitability of Documents related to stability Biocompatibility and sterilization Consultant + Client
Step 12 Identify test requirements. Consultant
Step 13 Certification and summery Consultant + Client
Step 14 Prepare Submission File. (510 k Notification) Consultant + Client
Step 15 Label review Consultant
Step 16 Product Testing Client Depends on Labs
Step 17 Appoint US Agent  ( Foreign manufactures) Client NA 649 USD / Year
Step 18 FDA Review Fee Payment Client 5 Days Fiscal Year 2016 – 5228 USD
Step 19 Notification Submission to FDA US Agent  / Consultant 14 Days
Step 20 Coordinate with FDA Reviewer US Agent + Consultant 60-180 days
Step 21 Supplementary Document Submission if requested by FDA Client Based on availability
Step 22 Establishment Registration Fee payment to FDA Client 5 Days Fiscal Year 2016 – 3845  USD (Yearly)
Step 23 Establishment Registration US Agent / Consultant 7 Days
Step 24 Device Listing US Agent / Consultant Free

Clients should depute one person who is experienced in documentation and good knowledge on particular device to coordinate with consultant.
Frequent E-Mails and Telephone/ Skype /G talk meeting is highly essential.

Payments

All payments to be made to I 3 Consulting as per the details mentioned in invoice.

Payments in 4 equal installments.

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