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  • Form 3601

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SINGLE TARGET FIELD FIRE I SCORECARD For use of this form see FM 3-22.9; the proponent agency is TRADOC. ID CODE UNIT DATE (YYYYMMDD) EVALUATOR'S ID CODE TABLE 1 SUPPORTED FIRING POSITION RD 1 2 3.

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The FD&C Act specifies the base fee for a premarket application for each year from FY 2023 through FY 2027; the base fee for a premarket application received by FDA during FY 2023 is $425,000.

What Is a User Fee? A user fee is a sum of money paid as a necessary condition to gain access to a particular service or facility. Examples of user fees could include highway tolls or parking garages. People pay user fees for the use of many government-affiliated services and facilities as well.

A user fee is a charge imposed by the government for the primary purpose of covering the cost of providing a service, directly raising funds from the people who benefit from the particular public good or service being provided.

When submitting a 510(K) you must compare your device to one or more legally marketed devices and then make and support your substantial equivalence claims. The overall cost to get FDA approval for a 510(K) notification ranges between $30,000 and $44,000 USD.

FDA Announces New Medical Device User Fees for FY 2023 Fee Type20222023Annual Establishment Registration$5,546$6,493Application FeesStandardStandard510(k)$12,745$19,870513(g)$5,061$5,9617 more rows • Oct 7, 2022

What are user fees? The FDA collects fees from companies that produce certain products, such as drugs and medical devices, and from some other entities, such as certain accreditation and certification bodies.

Under the user fee system, medical device companies pay fees to the FDA when they register their establishments and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the U.S. and for certain other types of submissions.

Form FDA 3601, the “Medical Device User Fee Cover Sheet,” is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to account for and track user fees.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232