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This document provides a summary of the 510(k) premarket notification for Agfa's DX-D FLFS, a direct radiography accessory intended for orthopedic imaging, detailing its description, intended use,

How to fill out premarket notification dx-d flfs

How to fill out Premarket Notification: DX-D FLFS

1. Gather product information including device type, intended use, and technological characteristics.
2. Prepare a cover letter explaining the submission and its purpose.
3. Complete the FDA Form 3514, providing details about the device and manufacturer.
4. Prepare a detailed description of the device, including design, materials, and functionalities.
5. Include labeling information, such as instructions for use and packaging details.
6. Provide performance testing data, including any bench, animal, or clinical studies.
7. Compile any additional relevant documents, such as certifications and previous submissions.
8. Submit the complete package electronically through the FDA's eSubmission Gateway.
9. Wait for the FDA's response, which may include requests for additional information.

Who needs Premarket Notification: DX-D FLFS?

1. Manufacturers of medical devices that fall under the DX-D FLFS category.
2. Companies seeking clearance to market their devices in the United States.
3. Developers looking to ensure their products meet FDA regulations before public release.

People Also Ask about

What is 510K exemption for premarket notifications?

510(k) Exempt Manufacturers can bring their devices to market without assurance of safety and effectiveness, but such products are still required to comply with all applicable device regulations, including the Quality System Regulation (QSR).

What is the meaning of premarket approval?

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

What is a premarket notification?

The premarket notification process is a regulatory control that is a component of general controls, guides medical device classification, and informs applicants and the FDA in the determination of substantial equivalence for new devices (FDA, 2014b).

What is an exemption from the 510K premarket notification requirements?

Most class I and class II devices are exempt from 510(k) requirements. Devices that may be 510(k) exempt include: Preamendment devices (devices legally marketed in the US prior to May 28, 1976) Class I devices specifically exempted by FDA or classified as class I under section 513 (with certain exceptions)

What is an FDA premarket number?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

What are the exemptions from FDA registration?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

What is the difference between premarket notification and 510K?

A retail food establishment is exempt from registration if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers (21 CFR 1.226(c) and 1.227).

For pdfFiller’s FAQs

What is Premarket Notification: DX-D FLFS?

Premarket Notification: DX-D FLFS refers to the process established by the FDA for certain medical devices, allowing manufacturers to inform the agency of their intent to market a device. It primarily ensures that the device is substantially equivalent to one already on the market.

Who is required to file Premarket Notification: DX-D FLFS?

Manufacturers or importers of medical devices that are not significantly different from existing devices must file a Premarket Notification: DX-D FLFS to obtain marketing clearance from the FDA.

How to fill out Premarket Notification: DX-D FLFS?

To fill out a Premarket Notification: DX-D FLFS, a manufacturer must complete the required forms, provide device descriptions, submit data supporting substantial equivalence to a predicate device, and include labeling and intended use information.

What is the purpose of Premarket Notification: DX-D FLFS?

The purpose of the Premarket Notification: DX-D FLFS is to ensure the safety and effectiveness of medical devices by requiring manufacturers to demonstrate that their products are substantially equivalent to devices already approved for marketing.

What information must be reported on Premarket Notification: DX-D FLFS?

Information required for Premarket Notification: DX-D FLFS includes the name and address of the manufacturer, device name, description, intended use, labeling, substantial equivalence information, and any performance testing data.