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This document summarizes the 510(k) premarket notification for the MobileDiagnost wDR, a mobile diagnostic x-ray system intended for use by qualified medical professionals. It includes device identification,

How to fill out 510ok summary special 510k

How to fill out 510O(K) Summary. Special 510(k) KI

1. Gather necessary information about the device, including its intended use, technology, and performance.
2. Identify the modifications made to the device and provide rationale for these changes.
3. Complete the 510(k) form, ensuring that all required sections are filled out, including device description, labeling, and substantial equivalence.
4. Provide performance testing data, if applicable, to support claims of safety and effectiveness.
5. Compile all supplementary documents, such as device manuals, labeling, and summary of studies.
6. Review the final submission for completeness and accuracy prior to sending it to the FDA.
7. Submit the 510(k) Summary electronically through the FDA's submission portal.

Who needs 510O(K) Summary. Special 510(k) KI?

1. Manufacturers of medical devices who have made modifications that do not significantly affect the intended use or performance of the device.
2. Companies seeking to market devices that are substantially equivalent to a legally marketed device.
3. Organizations aiming to streamline the FDA review process for minor changes to existing devices.

People Also Ask about

What is special 510k?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the device's intended

What is the 510K decision making process?

It is worth noting that the most common time window to clearance (median) is 80-90 days, followed very closely by 50-60 days.

What is the 510K approval process?

The FDA receives 510(k) application. The FDA sends an Acknowledgement Letter or a Hold Letter if there are issues with user fees and/or eCopy. The FDA conducts an Acceptance Review. FDA informs the applicant if 510(k) is accepted for Substantive Review or placed on RTA Hold.

How long does 510 K clearance take?

Information For Step 1: Device Discovery and Concept. Step 2: Preclinical Research-Prototype. Step 3: Pathway to Approval. Step 4: FDA Device Review. Step 5: FDA Post-Market Device Safety Monitoring.

What is the 510k summary?

The Special 510(k) program is efficient and consistent with the least burdensome review procedure that helps foreign manufacturers to sell their devices within the USA and allows patients to get timely access to new medical devices.

What is the FDA 510k summary?

Overview of Section 510(k) This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.

What does 501k clearance mean?

Once the FDA have received your submission, the FDA will officially start the clock on your decision timeline. At the time of writing the FDA states that a traditional 510(k) decision should be provided within 90 days.

What is 510k summary report?

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.

What are the 5 phases of the medical device development process?

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 5 10k approval process?

There are three types of 510(k) submissions: Traditional, Abbreviated, and Special. Each type has its own requirements and may be appropriate for different types of medical devices. Traditional, Special, and Abbreviated 510(k)s require the same user fee.

For pdfFiller’s FAQs

What is 510O(K) Summary. Special 510(k) KI?

The 510(k) Summary is a document submitted to the FDA that outlines the safety and effectiveness of a device for which a manufacturer is seeking clearance to market. A Special 510(k) is a streamlined process for devices that have modifications, allowing for quicker review and approval.

Who is required to file 510O(K) Summary. Special 510(k) KI?

Manufacturers of medical devices who are making specific modifications to an already cleared device are required to file a Special 510(k) Summary. This applies to those who are making changes that do not significantly affect the device's intended use or safety.

How to fill out 510O(K) Summary. Special 510(k) KI?

To fill out a Special 510(k) Summary, manufacturers need to provide information including device name, description, predicate device details, a summary of changes, nonclinical and clinical data (if applicable), and a rationale for the modifications. Documentation must be formatted according to FDA guidelines.

What is the purpose of 510O(K) Summary. Special 510(k) KI?

The purpose of the 510(k) Summary in the Special 510(k) process is to demonstrate that a modified device is substantially equivalent to a legally marketed predicate device, ensuring that it meets regulatory standards for safety and effectiveness.

What information must be reported on 510O(K) Summary. Special 510(k) KI?

Key information required in a 510(k) Summary includes device identification, manufacturer information, description of the modifications, performance testing data, labeling changes, and a summary of how the device continues to be comparable to the predicate device.