ACTIVE MEDICAL DEVICES
IMPLANT MEDICAL DEVICES
DISPOSABLE MEDICAL DEVICES
SOFTWARE MEDICAL DEVICES
IVD MEDICAL DEVICES



US FDA 510k Documentation & Submission Fees

(Consulting, 510k Prepration, Pre-submission, Final Submission & US Agent)

US FDA Medical Device Establishment Registration Annual Fee (FY 2020) : 5236 USD

FDA 510k Review Fee FY-2020 (Standard) : 11594 USD

FDA 510k Review Fee FY-2020 (Small Business) : 2899 USD

Clients may make above payments directly to US FDA

OPTION 1: FDA 510k Complete Package Fees

Payable to MedDeviceCorp [Oct 2019 - Sep 2020]

Type of Device

Guidance Fee

510k (File) preparation

Submission Fee

Non-invasive

7500 – 8500 USD

5000 – 6000 USD

500 USD

Invasive

9500 – 10500 USD

6000 - 7000 USD

500 USD

Implant

11000 - 12500 USD

6500 - 7500 USD

500 USD

OPTION 2: FDA 510k Partial Service Fees

Payable to MedDeviceCorp [Oct 2019 - Sep 2020]

Activity

Cost

Remarks

USFDA 510k detailed Review

5500 - 7500 USD /510k

Device Code, Regulation Number & Predicate device accurate information must be provided by the client.

Timeline 30 working days

USFDA 510k Quick Review +

FDA Pre-Submission *

5000-6500 USD/510k

Expected timeline 90 to 120 days.

US Agent Fees, File Conversion & Stationery / Courier charges included

( No payment needed for FDA)

* 510k submission can be added to above service with addition fees of 1500 USD

USFDA 510k Pre-Submission

2500 USD /510k

US Agent Fees, File Conversion & Stationery / Courier charges included

Expected timeline 90 days.

( No payment needed for FDA)

USFDA 510k Pre-Submission + FDA 510k Submission

5500 USD / 510k

Expected Pre-Submission timeline 90 days

Expected 510(k) Review timeline 120 days

FDA Pre-Submission is free and 510k Submission FY review charges applicable

US Agent Fees, File Conversion & Stationery / Courier charges included

Important

  • Country specific Government taxes additional.
  • Consultant onsite visit based on customer request. Travelling and Boarding extra invoiced on actulas.
  • Project cost divided into 4 installements based on the progress of project.
  • Method of communication - Email / Telephone / Skype / Whatsapp.
  • Language for communication – English.
  • Complete documention by Cloud server.
  • 510k prepration timeline 60 to 90 mandays and Pre-submission approx 90 mandays.
  • Expected timleline for completing FDA multiple reviews and Clereance 140 - 180 working days.

Looking for a detailed estimate? Please fill up the Request for Quote and submit online. Our Experts will study the information submitted and will revert back to you soon.

Request For Quote – Click Here

Recent Client Testimonial:


FDA 510k Fees Reviewed by Mr. Evan in . Value for Money. The FDA 510k Fees provided by MedDeviceCorp team is best in the industry and value for money. Rating: 4.9