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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66G609 Silver Spring, MD 209930002 March 19, 2015.

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How are application fees paid? Payment of prescribed fees as indicated in the Order of Payment may be done through the FDA Cashier, the bank (i.e., Landbank of the Philippines, Development Bank of the Philippines, Bancnet), or online thru Bancnet on the existing FDA issuance.

Section 513(g) of the Federal Food, Drug, and Cosmetic Act provides a means for device manufacturers to obtain information about the Food and Drug Administration's views regarding the classification of a device. According to the legislation, a company can submit a written request to the secretary.

Payment Types. Electronic payment. Mailing in a Paper Check. Payments by Wire Transfer.

Approximately 4,000 510(k) applications are submitted to the FDA each year compared to less than 100 PMA applications. The average cost to bring a medical device to market through the 510(k) pathway is $31 million compared to the PMA pathway with average costs of $94 million.

The average length of time for clearance under the traditional 510(k) pathway is 177 days, or nearly six months. Just 19% of devices on the 510(k) pathway are cleared within three months. The average number of days it takes to clear a device via 510(k) varies according to the device category.

Our fee for this service ranges from $12,000 - $20,000, depending on complexity and existing device documentation. The FDA charges to review the entire 510(k) application, the product, and the business that is applying for the FDA 510(k) clearance approval.

A firm's registration or owner/operator number can be found in the Public Registration and Listing database at https:// www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm. However, medical device listing number(s) are not available publicly.

Q-Sub Type: Pre-Submissions A formal written request for feedback from FDA to help. guide product development and/or application preparation.

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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