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This document provides a summary of the special 510(k) premarket notification for the HAMILTON-Ti ventilator, detailing its intended use, device description, and regulatory compliance.

How to fill out special 510k summary

How to fill out SPECIAL 510(k) SUMMARY

1. Begin by reviewing the FDA's guidance on the Special 510(k) process.
2. Gather all necessary documentation about your device, including its intended use and design.
3. Clearly describe the modifications made to the device compared to the previously cleared version.
4. Provide evidence that the modifications do not affect the safety and effectiveness of the device.
5. Fill out the Special 510(k) application form, ensuring all fields are completed properly.
6. Include any relevant test results that support the changes made to the device.
7. Submit the Special 510(k) along with a cover letter, indicating the reason for the submission.
8. Monitor for any communications from the FDA regarding your submission.

Who needs SPECIAL 510(k) SUMMARY?

1. Manufacturers who need to submit changes to a previously cleared medical device.
2. Developers of medical devices that have implemented modifications that do not significantly affect their safety or effectiveness.
3. Entities looking to expedite the regulatory review process for minor changes to existing devices.

People Also Ask about

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 approval process?

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 does 501k clearance mean?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

What is special 510k?

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 5 10k approval process?

The focus of the 510(k) process is to prove something called 'substantial equivalence'. In other words, the aim of the game is to prove to the FDA that the medical device you want to bring to market is broadly similar to another device that's already on the market, known as a predicate device.

What is a 510k summary or statement?

The 510(k) Statement is a certification that the 510(k) owner will provide safety and effectiveness information supporting the FDA finding of substantial equivalence to ANY person within 30 days of a written request.

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

The FDA 510(k) submission process is a critical gateway for medical device manufacturers seeking approval for their products in the United States. However, a concerning trend has emerged – a staggering 25% of these submissions are facing rejection due to lack of completeness.

What does 501k clearance mean?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

What does 510k approval 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 a 510k statement?

FDA Clearance. A 510(k) is a premarket submission made to the FDA. It is called a 510(k) because it refers to that section of the Food, Drug and Cosmetic Act. It is the regulatory pathway mostly utilized for Class II devices that hope to be substantially equivalent to another device which is currently legally marketed.

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What is SPECIAL 510(k) SUMMARY?

The Special 510(k) Summary is a streamlined submission process for certain modifications to devices that have already received FDA clearance, allowing manufacturers to report changes that do not significantly affect the safety or effectiveness of the device.

Who is required to file SPECIAL 510(k) SUMMARY?

Manufacturers of medical devices that have an existing 510(k) clearance and wish to modify their devices in ways that do not significantly affect safety or effectiveness are required to file a Special 510(k) Summary.

How to fill out SPECIAL 510(k) SUMMARY?

To fill out a Special 510(k) Summary, manufacturers must complete the FDA's Special 510(k) application form, provide information and data that demonstrate how the modification meets the requirements for safety and effectiveness, and include a summary of the device modifications.

What is the purpose of SPECIAL 510(k) SUMMARY?

The purpose of the Special 510(k) Summary is to facilitate a more efficient submission process for device modifications that are considered minor and do not involve significant changes to the intended use or technology of the device.

What information must be reported on SPECIAL 510(k) SUMMARY?

The information that must be reported on a Special 510(k) Summary includes device name, 510(k) number, a description of the device modification, a summary of the safety and effectiveness information, and any relevant labeling changes.