Get the free 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

This document provides a summary of a 510(k) submission for a new diabetes data manager application intended for use with the OneTouch® Verio Sync Blood Glucose Monitoring System, detailing its purpose,

How to fill out 510k substantial equivalence determination

How to fill out 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

1. Begin by gathering all necessary information about the device.
2. Review the FDA's guidance on 510(k) submissions.
3. Identify the intended use and comparison devices.
4. Document the device description, including materials and specifications.
5. Explain the technological characteristics and how they compare to existing devices.
6. Provide performance data, including any relevant testing results.
7. Address any potential risks and submit strategies for risk management.
8. Compiling all documentation into a coherent format as per the FDA's guidelines.
9. Submit the 510(k) for review, ensuring all sections are complete and accurate.

Who needs 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY?

1. Manufacturers of medical devices seeking to market their products in the United States.
2. Companies looking to demonstrate that their devices are substantially equivalent to legally marketed devices.
3. Entities that need to comply with FDA regulations for product approval.

People Also Ask about

What is the 510k approach?

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 a 510 K summary?

510(k) Summary or Statement. Prepare either a 510(k) Summary or a 510(k) Statement. The Summary or Statement is required for all 510(k)s whether the device is Class I, II, or III. A 510(k) Summary is a summary of information upon which you based your claim of substantial equivalence.

How to prove substantial equivalence?

Demonstrate substantial equivalence in 5 steps Determine if your product's intended use is substantially equivalent to a predicate device. Identify similarities and differences between your product and predicate device to be included in comparison table.

What does 501k mean?

The term refers to the use of low-load and presumably high performance permanent life insurance as a superior alternative to traditional retirement plans. A 501(k) plan document is often not required by IRS or state tax authorities but may be advisable or required for other purposes.

What does 510 K 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).

What is 501k approval?

The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of similarities to a current medical device that is already on the market.

What is the difference between FDA and FDA 510k?

The FDA (Food and Drug Administration) is an enforcement body in charge of safeguarding the public's welfare by guaranteeing the health, safety, and effectiveness of different goods, whereas an FDA 510(k) is a specialized premarket submission procedure for medical products that demonstrates significant similarity to a

When to submit a 510k FDA decision?

Manufacturers are required to submit a new 510(k) when a change (or changes) exceeds the 21 CFR 807.81(a)(3) threshold, “could significantly affect the safety or effectiveness of the device,” or constitutes a “major change or modification in the intended use of the device.” This significant effect could be positive or

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What is 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY?

The 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY is a document that provides an overview of the FDA's review process for a device submitted for market clearance under section 510(k) of the Federal Food, Drug, and Cosmetic Act. It summarizes the rationale for determining whether a new device is substantially equivalent to a legally marketed device.

Who is required to file 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY?

Manufacturers or importers of medical devices that intend to market a device in the United States which is not exempt from premarket notification requirements are required to file the 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY.

How to fill out 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY?

To fill out the 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY, submitters must complete a standardized format provided by the FDA, including device description, intended use, comparison with predicate devices, labeling, and any supporting data such as safety and effectiveness information.

What is the purpose of 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY?

The purpose of the 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY is to document the FDA's evaluation and determination that a device is substantially equivalent to a predicate device, allowing it to be marketed in the U.S. without the need for a more rigorous premarket approval process.

What information must be reported on 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY?

The information that must be reported includes device name, applicant details, summary of the device, a comparison to the predicate device, information on labeling, any pertinent safety and efficacy data, and FDA's decision on substantial equivalence.