What is de novo classification?
De Novo classification is a risk-based classification process. Devices that are classified into class I or class II through a De Novo classification request (De Novo request) may be marketed and used as predicates for future premarket notification [510(k)] submissions, when applicable.
What is FDA 513g?
A “513g” is a request for classification information from the FDA. The FDA is required by the regulation to provide a written response within 60 days of receiving the 513g request. The submission also requires payment of an FDA user fee that is eligible for a small business discount.
How long does a 513 g take?
60 days
Once the FDA receives a 513(g) request, a response can take up to 60 days.
What does FDA unclassified mean?
1 An unclassified device is a pre-amendments device for which a classification regulation has not been promulgated. Unclassified devices require submission of a 510(k) premarket notification to CDRH.
What is IDE FDA?
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices.
How do I file a 513g?
Medical device companies should submit a 513(g) application in writing to the appropriate office and identify it as such. The application should contain a cover letter, a description of the device, a description of the indicated use of the device, any proposed labeling and marketing materials for the device.
What is 513 g submission FDA?
Section 513(g) governs requests “for information respecting the class in which a device has been classified or the requirements applicable to a device under [the] Act.” Submissions that do not request such information are outside the scope of section 513(g).
What is a 513 g request?
A 513(g) request is a means for medical device manufacturers to obtain information about the FDA’s views regarding the classification and regulatory requirements for a particular product.
What are FDA codes?
An FDA product code describes a specific product and contains a combination of five to seven numbers and letters. The product code submitted with each FDA line item should match the actual product name and/or invoice description of the product.
Which FDA database is used for product classification?
The Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission. This database contains device names and their associated product codes.
What is an abuse of discretion?
The abuse of discretion standard is used for when a lower court makes a discretionary ruling. On appeal, if a party challenges the ruling, then the appellate court will use the abuse of discretion standard to review the ruling.