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US FDA User Fees for FY 2016

Discussion in 'Medical Devices (21 CFR Part 820)' started by Sreenu, Aug 4, 2015.

Sreenu New Member

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Hi All,

On 3 Aug 2015, US FDA has announced the user fees for FY 2016.

Summary:
1. Establishment Registration: $3845
2. 510(k): $5228 (Small Business: $2614)
3. PMA/PDP/BLA/PMR: $261,388 (small business: $65,347)

Full details, follow the below link:

http://www.gpo.gov/fdsys/pkg/FR-201...ivery&utm_medium=email&utm_source=govdelivery

Regards,
Sreenu

Sreenu, Aug 4, 2015

#1

QAengineer13, OrangeIsEnergy, Somashekar and 1 other person like this.

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