Get the free 510(k) SUMMARY (as required by 21 CFR 807.92) - accessdata fda

A summary of the 510(k) premarket notification submitted to the FDA for the Aesculap® MonoMax absorbable suture, including device description, indications for use, performance data, and substantial

How to fill out 510k summary as required

How to fill out 510(k) SUMMARY (as required by 21 CFR 807.92)

1. Gather device identification information including the name, intended use, and classification.
2. Provide a summary of the technological characteristics and performance specifications of the device.
3. Identify the predicate device(s) and provide a comparison in terms of safety and effectiveness.
4. Detail any non-clinical and clinical testing data that supports the substantial equivalence claim.
5. Include a summary of labeling information.
6. Sign and date the summary as the owner/operator of the device.

Who needs 510(k) SUMMARY (as required by 21 CFR 807.92)?

1. Manufacturers of medical devices that are seeking clearance to market their device in the United States.
2. Entities that are introducing a device that is substantially equivalent to a legally marketed device.

People Also Ask about

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.

What is the 510k requirement?

To obtain 510(k) clearance, a medical device manufacturer submits a package of documents to FDA for review. The objective of the documentation is to support the substantial equivalence of the new device to one that is already on the market (known as a predicate device).

What is the 510k pathway?

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 difference between 510k and FDA approval?

The purpose of a 510(k) submission is to prove that your device is safe and effective by comparing it to a similar, legally marketed device—what the FDA calls a “predicate device.” If your 510(k) submission is approved, your product has earned FDA clearance, and you can legally market it.

What are the three types of 510k?

If so, then the 510(k) pathway is not appropriate, and instead, a De Novo or PMA is needed. 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.

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).

How do you determine if a medical device would require a 510 K approval instead of PMA?

These two pathways determine the speed, complexity, and cost of your product's approval. While 510(k) clearance is used for most Class II devices with existing market equivalents, PMA (Premarket Approval) is required for high-risk or entirely novel Class III products.

What is required for 510k submission?

Proper documentation of the device design — Detailed documentation of the device design and how it works is a critical component of the 510(k) submission. The documentation must include drawings, schematics, and a description of the device's intended use and performance.

For pdfFiller’s FAQs

What is 510(k) SUMMARY (as required by 21 CFR 807.92)?

The 510(k) summary is a document that provides a summary of the safety and effectiveness data, as well as a description of the device and its intended use, submitted to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

Who is required to file 510(k) SUMMARY (as required by 21 CFR 807.92)?

Manufacturers of medical devices that are seeking to market a device that is not exempt from premarket notification requirements and that is intended for commercial distribution in the United States are required to file a 510(k) summary.

How to fill out 510(k) SUMMARY (as required by 21 CFR 807.92)?

Filling out a 510(k) summary involves providing detailed information about the device, including its name, intended use, description, the predicate device to which it is compared, performance data, and any other relevant safety and effectiveness information as outlined in 21 CFR 807.92.

What is the purpose of 510(k) SUMMARY (as required by 21 CFR 807.92)?

The purpose of the 510(k) summary is to provide the FDA with sufficient information to determine whether the new device is substantially equivalent to a predicate device, thereby allowing it to be marketed in the U.S. without the need for premarket approval (PMA).

What information must be reported on 510(k) SUMMARY (as required by 21 CFR 807.92)?

The 510(k) summary must include device identification information, a description of the device and its intended use, the basis for substantial equivalence, performance testing data, and any relevant labeling information along with a declaration regarding the compliance with any applicable performance standards.