FDA Home Page | CDRH Home Page | Search | A-Z Index

FDA > CDRH > CDRH Learn > Presentation: 513(g)s - Including 513(g) User Fees

Presentation: “513(g)s”…Including 513(g) User Fees

(This presentation is also available in video format with captioning and PDF printer-friendly format.)

Lawrence “Jake” Romanell
Network Leader
Regulatory Affairs and Special Interests Network
Office of the Director
Center for Devices and Radiological Health

At the End of this Module . . .

One should know:

• What is a 513(g) Request for Information
• What questions may be asked under the 513(g) Process
• What Opinions are given to 513(g) Requests
• How to put together a 513(g) Request
  

Section 513(g) of the Act

• “Within 60 days of the receipt of a written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device under this Act, the Secretary shall provide such person a written statement of the classification (if any) of such device and the requirements of this Act applicable to the device.”

Section 513(g) of the Act

• “Within 60 days of the receipt of a written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device under this Act, the Secretary shall provide such person a written statement of the classification (if any) of such device and the requirements of this Act applicable to the device.”

513(g) “Typical” Inquiries

• To date, most inquiries are submitted to:
  • Determine whether a product is subject to FDA regulations.
  • Determine whether a device is exempt from the 510(k) requirements of the Act.
  • Determine whether a 510(k) is needed for a modification to one's device.
  • Determine the least burdensome regulatory pathway for a device, which introduces a new technology or a new intended use.

513(g) Yearly Submissions

Current Change to the 513(g) Review Process

Charging of User fees in FY 09:

• 510(k) Std. Fee $3,693.00
• 513(g) Std. Fee $2,710.00
  
• 510(k) Small Business Fee $1,847.00
• 513(g) Small Business Fee $1,355.00
  

Section 513(g) of the Act

“Within 60 days of the receipt of a written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device under this Act, the Secretary shall provide such person a written statement of the classification (if any) of such device and the requirements of this Act applicable to the device.”30

FDA responses to requests for information about the regulatory requirements applicable to a particular device DO NOT constitute FDA clearance or approval for distribution of that particular device in the United States.

OPINIONS* offered as responses to 513(g) Requests on Software

• Classified device requiring a 510(k) submission – 34
• Classified device exempt from 510(k) requirements – 16
• Unclassified device requiring a 510(k) submission - 9
• Unclassified device under enforcement discretion - 6
• Not a device - 6
• General purpose article - 2
• Drug regulated by CDER - 2
• Biologic regulated by CBER - 1
• Classified device requiring a PMA submission - 1
• Not a finished device - 1
  
  * - May not be the sole opinion given in response to a request.

Contents of a 513(g) Request:

• A Cover Letter.
• A complete Device Description.
• A concise Indication(s) for Use Statement.
• Either proposed labeling or labeling of a marketed similar product/device.

Mailing Address:

Office of Device Evaluation
Center for Devices and Radiological Health
c/o Document Mail Center (HFZ-401)
9200 Corporate Boulevard
Rockville, MD 20850

ORIGINAL AND ONE COPY PLEASE

513(g) Contact Person

Diane Garcia
510(k) Staff
Program Operations Staff
Office of Device Evaluation
Center for Devices and Radiological Health
240-276-4027
CDRHLearn@fda.hhs.gov

Updated January 8, 2009

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH