USFDA Consulting charges




FDA review fees FY 2007 to FY 2012
Table I

Fiscal Year FDA 510K review Standard Fee FDA 510K review Fee for Small Business Establishment Registration Fee
Oct 2007 –Sep 2008 3404.00 USD 1702.00 USD 1706.00 USD
Oct 2008 –Sep 2009 3404.00 USD 1702.00 USD 1706.00 USD
Oct 2009 –Sep 2010 3693.00 USD 1847.00 USD 1851.00 USD
Oct 2010 –Sep 2011 4348.00 USD 2174.00 USD 2179.00 USD
Oct 2011 –Sep 2012 4717.00 USD 2359.00 USD 2364.00 USD
  • All payments should be made directly to FDA

Technical Consulting Fee for FDA 510k
Table II

Type of Device Guidance Fee Preparation of 510(K) Notification Submission Fee
Biocompatible device 2000 – 2500 USD 2000 – 2500 USD 500 USD
Electromagnetic device 3000 – 3500 USD 2500- 3000 USD 500 USD
Radio Therapy equipments 3000 - 3500 USD 2500 - 3000 USD 500 USD
  • Payments can be made in equivalent Indian rupees or US dollars. Govt. taxes applicable.
  • Factory / Onsite will be customer discretion. Travelling and Boarding as per actual invoiced.
  • Exact fee can be calculated only after understanding the product /Equipment
  • Table III fees included in Table II fee structure

Technical Consulting Fee
Table III

Activity FEE Annual Charges
Labeling Review 649 USD /Device NA
Establishment Registration 149 USD 149 USD
Device Listing 99 USD /Device NA
US Agent Fee 449 USD / Category 400 USD
  • Payments can be made in equivalent Indian rupees or US dollars. Govt. taxes applicable at actual, it will be informed in your proposal.

GMP (QSR) Consulting fee
Table IV

Activity FEE Timeline
21 CFR 820 GAP Analysis 500 USD / Day -
21 CFR 820 Internal Audit 300 USD / Day -
21 CFR 820 Internal audit Training 1000 USD / Day 2 Days / 12Hrs
21 CFR 820 Implementation Consultancy Starts with 10000 USD * 120 Days above


  • Payments can be made in equivalent Indian rupees or US dollars. Govt. taxes applicable.
  • Project time line depends on class of Product and size of the organization
  • Travelling and Lodging additional on actual.

Contact us

A1-101, Ankur,
Near Cipla Foundation,
Warje, Pune- 411058

E mail :- info@avscertification.com
Telephone :- +91 - 9881946595



Design & Developed By : Logic Palace Systems and Softwares
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