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This document serves as a premarket notification for the SF1-Bar® dental implant abutment, demonstrating its substantial equivalence to legally marketed devices, thereby allowing its market entry

How to fill out special 510k - sf1-bar

How to fill out Special 510(k) - SF1-Bar®

1. Identify the device you are submitting for a Special 510(k) - SF1-Bar®.
2. Ensure that your device is a modification to a device that is already cleared under the 510(k) process.
3. Gather all necessary documentation, including device descriptions, predicate device information, and the intended use.
4. Complete the Special 510(k) submission form, ensuring that you address all aspects of the modifications made to the device.
5. Provide evidence that the modification does not affect the intended use or alter the safety and effectiveness of the device.
6. Submit the completed Special 510(k) application electronically via the FDA's submission portal.
7. Respond to any additional requests or queries from the FDA during the review process.

Who needs Special 510(k) - SF1-Bar®?

1. Manufacturers who have made a modification to a previously cleared 510(k) device.
2. Companies seeking a faster review process for devices that do not involve major changes.
3. Organizations aiming to ensure regulatory compliance while introducing minor adjustments to their devices.
4. Firms required to demonstrate that the modified device remains as safe and effective as the original.

People Also Ask about

What is the difference between traditional 510k and special 510k?

The difference between the three types of 510(k) submissions comes down to how you prove substantial equivalence: Traditional 510(k): Prove substantial equivalence to a legally marketed predicate device. Special 510(k): Prove substantial equivalence to your own previously cleared device.

What is the FDA Special 510k program?

Special 510(k)s allow FDA and industry to rely on previous Agency review of detailed information, where appropriate, without altering any statutory or regulatory requirements related to the premarket notification process under sections 510 and 513 of the FD&C Act, and 21 CFR 807 Subpart E.

What is a special 510K review?

The Special 510(k) Program is intended to facilitate the submission, review, and clearance of a change to a manufacturer's own legally marketed predicate device ("existing device") that is already authorized for commercial distribution through 510(k) clearance, preamendments status, reclassification, or through a

Does 510k mean FDA approved?

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).

How long does it take to get approved for special 510K?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days.

How long does it take to get approved for special 510k?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days.

What does FDA 510k approved mean?

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).

What is the difference between 510k and special 510k?

The difference between the three types of 510(k) submissions comes down to how you prove substantial equivalence: Traditional 510(k): Prove substantial equivalence to a legally marketed predicate device. Special 510(k): Prove substantial equivalence to your own previously cleared device.

What is the difference between a 510K and a de novo 510K?

De Novo submissions establish a new classification for devices without predicates and offer a streamlined pathway for low—to moderate-risk devices. 510(k) submissions rely on the substantial equivalence to a predicate device and are the most common route for device approval.

What is the difference between traditional and special 510K?

The difference between the three types of 510(k) submissions comes down to how you prove substantial equivalence: Traditional 510(k): Prove substantial equivalence to a legally marketed predicate device. Special 510(k): Prove substantial equivalence to your own previously cleared device.

For pdfFiller’s FAQs

What is Special 510(k) - SF1-Bar®?

Special 510(k) - SF1-Bar® is a submission process established by the FDA that allows for the expedited review of certain types of medical devices that have modifications, as long as those devices are already cleared under the original 510(k) process.

Who is required to file Special 510(k) - SF1-Bar®?

Manufacturers of medical devices that have made changes to devices already cleared by the FDA under the 510(k) process and need to demonstrate that these changes do not raise new questions of safety and effectiveness are required to file a Special 510(k) - SF1-Bar®.

How to fill out Special 510(k) - SF1-Bar®?

To fill out a Special 510(k) - SF1-Bar®, manufacturers must complete a specific form provided by the FDA, including details about the device modifications, data supporting the modifications, and any necessary testing or clinical information.

What is the purpose of Special 510(k) - SF1-Bar®?

The purpose of Special 510(k) - SF1-Bar® is to facilitate a streamlined review process for device modifications that do not significantly alter the intended use or technological characteristics of the device, helping to bring innovations to market more quickly.

What information must be reported on Special 510(k) - SF1-Bar®?

Information that must be reported includes the identification of the device, a description of the modifications, supporting data or information that demonstrates safety and effectiveness, and an assessment of how the changes comply with applicable regulatory requirements.