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This document provides a summary of a 510(k) premarket notification for blood transfusion sets, outlining device details, intended use, and regulatory classification.

How to fill out special 510k blood transfusion

How to fill out Special 510(k) Blood Transfusion Sets

1. Gather all necessary documentation, including device specifications and performance data.
2. Complete the Device Description section, providing detailed information about the blood transfusion set.
3. Fill out the Intended Use and Indications for Use section, clearly outlining the purpose of the device.
4. Include any clinical data that supports safety and effectiveness, if applicable.
5. Compile any labeling information, ensuring it meets FDA requirements.
6. Complete the Comparison to Predicate Device section, highlighting similarities and differences.
7. Submit the Special 510(k) application through the FDA's electronic submission system.
8. Pay any associated fees and track the status of your submission.

Who needs Special 510(k) Blood Transfusion Sets?

1. Manufacturers of blood transfusion sets that require FDA clearance for modifications.
2. Healthcare facilities seeking to use or procure new blood transfusion sets.
3. Regulatory professionals involved in the compliance of medical devices.

People Also Ask about

What is special 510 k?

The Special 510(k) Program is consistent with FDA's statutory mission to protect and promote human health and FDA's commitment to helping patients gain timely access to new medical devices that are high quality, safe and effective by using efficient review practices consistent with least burdensome principles.

What does 510k clearance mean?

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) that is not subject to premarket approval.

Is 510k FDA approved?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

What does 501k clearance mean?

Your 510(k) submission should: Demonstrate your medical device is 'substantially equivalent' to a predicate already on the market. House detailed technical, safety and performance device/test information to show your device is safe and effective. Prove you have a robust medical device quality and risk management system.

What is the 510k clearance?

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 FDA approval?

On the path to market, a granted de novo request has roughly the same weight as a “cleared” 510(k) submission. Both mean that FDA has opened the door to the market. FDA Approved: This term is reserved for the highest risk “Pre market approval” or PMA devices.

For pdfFiller’s FAQs

What is Special 510(k) Blood Transfusion Sets?

Special 510(k) Blood Transfusion Sets are a streamlined process by the FDA for manufacturers to submit modifications to their already cleared blood transfusion devices that do not require full premarket notification.

Who is required to file Special 510(k) Blood Transfusion Sets?

Manufacturers of blood transfusion sets who intend to make specific modifications to devices that are already legally marketed and have been cleared by the FDA are required to file a Special 510(k).

How to fill out Special 510(k) Blood Transfusion Sets?

To fill out a Special 510(k), manufacturers need to complete the FDA's submission form by providing device identification, the rationale for the modification, performance data, and evidence that the device remains safe and effective.

What is the purpose of Special 510(k) Blood Transfusion Sets?

The purpose of Special 510(k) Blood Transfusion Sets is to allow manufacturers to efficiently obtain FDA clearance for device modifications that do not significantly alter the intended use or technological characteristics of the original device.

What information must be reported on Special 510(k) Blood Transfusion Sets?

The information that must be reported includes the device description, intended use, details of the modifications, performance testing results, and any relevant labeling changes.