Wanted to sell your product in United States? Register your establishment and List the Medical Device prior to launch.
As you are aware, to sell medical device in United States of America, the seller should met any of the below conditions before Lisiting the Medical Device with FDA.
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 provide guidance and prepare 510k completely and submit through US Agent followed by coordination with FDA during file review. Our Online service is accepted by medical device manufacturers worldwide. It is fast and economic!!!
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
|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.
All payments to be made to I 3 Consulting as per the details mentioned in invoice.
Payments in 4 equal installments.