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If you've ever submitted a Pre-Submission to FDA and their feedback included a recommendation to submit a 513(g), this flowchart is for you!
Per FDA's Guidance, "FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act," (issued August 23, 2024), you can submit a 513(g) Request for Information to obtain "the agency's views about the classification and the regulatory requirements that may be applicable to your particular device."
Section 513(g) of the Food, Drug and Cosmetic Act states that, "Within sixty 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...The Secretary shall provide...a written statement of the classification (if any) of such device."
Sounds great, right?
While FDA will charge you ~$8K to submit a request (or ~$4K if you're a small business), FDA does not face any consequences for missing the 60-day review window.
This flowchart will help you determine whether a 513(g) is appropriate for your device!
If you've ever submitted a Pre-Submission to FDA and their feedback included a recommendation to submit a 513(g), this flowchart is for you!
Per FDA's Guidance, "FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act," (issued August 23, 2024), you can submit a 513(g) Request for Information to obtain "the agency's views about the classification and the regulatory requirements that may be applicable to your particular device."
Section 513(g) of the Food, Drug and Cosmetic Act states that, "Within sixty 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...The Secretary shall provide...a written statement of the classification (if any) of such device."
Sounds great, right?
While FDA will charge you ~$8K to submit a request (or ~$4K if you're a small business), FDA does not face any consequences for missing the 60-day review window.
This flowchart will help you determine whether a 513(g) is appropriate for your device!