Get the free 510(K) Summary - accessdata fda

A summary detailing the premarket notification for the Blue Sky Bio Dental Implant System, including device description, intended use, technological characteristics, safety and efficacy evaluations,

How to fill out 510k summary - accessdata

How to fill out 510(K) Summary

1. Identify the device: Clearly specify the medical device you are submitting.
2. Prepare the summary: Create a summary that includes device description, intended use, and technological characteristics.
3. Include references: List similar devices that are already on the market (predicate devices).
4. Describe performance testing: Provide details of any performance data and testing conducted to assess the device.
5. Address safety and efficacy: Discuss how your device is safe and effective for its intended use.
6. Package the summary: Ensure all required sections are included and formatted according to FDA guidelines.
7. Submit to the FDA: Submit your completed 510(K) Summary along with the required application forms.

Who needs 510(K) Summary?

1. Manufacturers of medical devices that require FDA clearance before marketing.
2. Companies planning to introduce a new device that is similar to an already approved device.
3. Businesses seeking to ensure compliance with regulatory standards for medical devices.

People Also Ask about

What is the content of a 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 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

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 is the 510 K process?

Most 510(k)s will include some type of performance data. The extent of performance data will depend on the complexity of the device and its intended use and indications. Performance data should be provided to help demonstrate SE of your device to one or more legally marketed devices (predicate device).

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.

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.

For pdfFiller’s FAQs

What is 510(K) Summary?

The 510(K) Summary is a document submitted to the FDA by medical device manufacturers to demonstrate that their device is safe and effective, and is substantially equivalent to a legally marketed device that is not subject to premarket approval.

Who is required to file 510(K) Summary?

Manufacturers of medical devices that are intended for human use and are classified as Class I or Class II, which are not exempt from premarket notification requirements, are required to file a 510(K) Summary.

How to fill out 510(K) Summary?

To fill out a 510(K) Summary, manufacturers must provide detailed information about the device, including its intended use, technological characteristics, and performance data. They should adhere to the guidelines provided by the FDA, ensuring all relevant information is clearly presented.

What is the purpose of 510(K) Summary?

The purpose of the 510(K) Summary is to inform the FDA and the public about the safety and effectiveness of a new medical device, demonstrating its substantial equivalence to existing devices.

What information must be reported on 510(K) Summary?

The information that must be reported on a 510(K) Summary includes the device name and classification, the names and addresses of manufacturers, a description of the device and its intended use, any applicable standards, and data supporting substantial equivalence.