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This document provides a 510(k) summary for the FDI Glucose Control Solution intended for evaluating the performance of FreeStyle Blood Glucose Monitors, detailing its classification, manufacturer,

How to fill out 510k premarket notification fdi

How to fill out 510(k) Premarket Notification: FDI Glucose Control Solution For FreeStyle

1. Identify the device classification and determine if a 510(k) is required.
2. Gather all necessary information about the FDI Glucose Control Solution.
3. Prepare the device description, including intended use and indications for use.
4. Compile information on the device's performance and labeling.
5. Conduct comparative analysis with similar devices on the market.
6. Fill out the 510(k) submission form with required details.
7. Submit the completed 510(k) along with the required fee to the FDA.
8. Respond to any FDA inquiries during the review process.

Who needs 510(k) Premarket Notification: FDI Glucose Control Solution For FreeStyle?

1. Manufacturers of the FDI Glucose Control Solution seeking to market their product in the U.S.
2. Importers and distributors of the device needing product clearance.
3. Healthcare professionals who wish to use or recommend the product.

People Also Ask about

What is a 510 K premarket notification?

Can any kind of glucose control solution be used? Control solution for glucose meters is made specific to each brand and type of test strip; there is no universal or generic brand.

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)

How long does it take for the 510 K determination in the case of traditional premarket notification?

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. Applicants with outstanding review issues will be notified within 100 days.

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 premarket notification 510k?

A 510(k) Premarket Notification is required for low to moderate risk medical devices classified as either Class I or Class II and not exempt from 510(k). Companies are unable to market their products to health care providers, patients and other consumers until they are given 510(k) clearance by the FDA.

For pdfFiller’s FAQs

What is 510(k) Premarket Notification: FDI Glucose Control Solution For FreeStyle?

The 510(k) Premarket Notification is a regulatory submission to the FDA to demonstrate that a medical device, like the FDI Glucose Control Solution for FreeStyle, is safe and effective and is substantially equivalent to a legally marketed device. This process allows manufacturers to gain market access without the need for a full Premarket Approval (PMA).

Who is required to file 510(k) Premarket Notification: FDI Glucose Control Solution For FreeStyle?

Manufacturers of the FDI Glucose Control Solution for FreeStyle are required to file a 510(k) Premarket Notification. This includes companies that produce or distribute the product, as they must demonstrate that their device is substantially equivalent to an existing device already cleared by the FDA.

How to fill out 510(k) Premarket Notification: FDI Glucose Control Solution For FreeStyle?

To fill out a 510(k) Premarket Notification for the FDI Glucose Control Solution for FreeStyle, manufacturers must complete a form that includes device name, description, indications for use, technological characteristics, performance data, labeling, and any substantial equivalence claims. The form must be submitted electronically through the FDA's eSubmitter tool.

What is the purpose of 510(k) Premarket Notification: FDI Glucose Control Solution For FreeStyle?

The purpose of the 510(k) Premarket Notification for the FDI Glucose Control Solution for FreeStyle is to ensure that the device is safe and effective for its intended use, and to verify that it is substantially equivalent to a predicate device. This process helps protect public health by ensuring that new or modified devices meet regulatory standards.

What information must be reported on 510(k) Premarket Notification: FDI Glucose Control Solution For FreeStyle?

The information that must be reported includes the device's name, indications for use, detailed description of the device, technological characteristics, comparative analysis with predicate devices, performance testing results, labeling information, and any additional data needed to demonstrate substantial equivalence.