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A regulatory submission detailing the safety and effectiveness of the Unicem Aplicap/Maxicap dental cement device for use in the dental field, comparing it with predicate devices.

How to fill out 510k summary of safety

How to fill out 510(k) Summary of Safety and Effectiveness

1. Identify the device that requires a 510(k) submission.
2. Gather relevant data and evidence to support the device's safety and effectiveness.
3. Complete the 510(k) form with all required information, including device description and intended use.
4. Provide a summary of the safety and effectiveness data, highlighting any preclinical or clinical studies conducted.
5. Include comparisons to any predicate device, explaining how the new device is substantially equivalent.
6. Ensure all labeling information is included, specifying any warnings, precautions, or contraindications.
7. Review and finalize the document for clarity and completeness before submission.

Who needs 510(k) Summary of Safety and Effectiveness?

1. Manufacturers of medical devices intended for commercial distribution in the U.S. that are not exempt from premarket notification.
2. Any entity looking to demonstrate that their device is substantially equivalent to a legally marketed device.
3. Companies entering the market with new variations or modifications of existing devices.

People Also Ask about

What is the 501k 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 is the rejection rate for 510k?

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 content of 510k summary?

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.

How long does FDA 510 K approval take?

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 are the three types of 510k?

There are three types of Premarket Notification 510(k)s that may be submitted to the FDA: Traditional, Special, and Abbreviated. In 1998, the FDA developed both the Special and Abbreviated 510(k) Programs to facilitate the review of certain types of submissions subject to 510(k) requirements.

How long does 501k approval take?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

Is 510k safe and effective?

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).

For pdfFiller’s FAQs

What is 510(k) Summary of Safety and Effectiveness?

The 510(k) Summary of Safety and Effectiveness is a document submitted to the FDA that provides evidence that a medical device is safe and effective for its intended use, demonstrating substantial equivalence to a legally marketed device.

Who is required to file 510(k) Summary of Safety and Effectiveness?

Manufacturers of certain medical devices that are intended for commercial distribution in the U.S. are required to file a 510(k) Summary of Safety and Effectiveness if their device is not exempt from premarket notification.

How to fill out 510(k) Summary of Safety and Effectiveness?

Filling out a 510(k) Summary requires providing detailed descriptions of the device, its intended use, comparisons to predicate devices, labeling information, performance data, and safety/effectiveness information as stipulated by FDA guidelines.

What is the purpose of 510(k) Summary of Safety and Effectiveness?

The purpose of the 510(k) Summary is to demonstrate that the new device is as safe and effective as a previously approved device, thereby allowing it to be marketed without the need for premarket approval.

What information must be reported on 510(k) Summary of Safety and Effectiveness?

Key information required in the 510(k) Summary includes the device name, manufacturer details, intended use, description, labeling, and data on safety and effectiveness, including any clinical studies conducted.