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This document summarizes the safety and effectiveness information for the Blood Pressure Monitor with Stethoscope submitted in accordance with FDA 510(k) requirements.

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device that requires 510(k) submission.
2. Gather relevant information and data about the device, including its intended use, technological characteristics, and comparison to predicate devices.
3. Compile the necessary documentation, including the 510(k) form, labeling, and performance testing results.
4. Prepare a summary of the device's safety and effectiveness based on the information gathered.
5. Submit the completed 510(k) summary to the FDA and wait for a response.

Who needs 510(k) Summary?

1. Manufacturers of medical devices that are substantially equivalent to a predicate device.
2. Companies looking to market their devices in the U.S. for the first time.
3. Developers of devices that require premarket clearance from the FDA.

People Also Ask about

What are the three types of 510k?

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. Traditional, Special, and Abbreviated 510(k)s require the same user fee.

What is the difference between 510k de novo and PMA?

PMA submissions are intended for high-risk devices, whereas De Novo and 510(k) are suitable for lower-risk devices with suitable predicates. Choosing the right submission pathway depends on various factors, including your device's risk level, the availability of predicates, and the resources you have available.

What are the different types of 510k s?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

What are class 1, class 2, and class 3 devices?

Class I (low to moderate risk): general controls. Class II (moderate to high risk): general controls and Special Controls. Class III (high risk): general controls and Premarket Approval (PMA)

What is the 510k pathway?

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 the purpose of a 510 K to determine?

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.

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.

What is the difference between 510k cleared and approved?

When a medical device is cleared, this means it has undergone a 510(k) submission, which FDA has reviewed and provided clearance. Approval: For Class III medical devices to be legally marketed they must undergo a rigorous review and approval process.

For pdfFiller’s FAQs

What is 510(k) Summary?

The 510(k) Summary is a document submitted to the FDA that provides evidence that a medical device is safe and effective for its intended use. It demonstrates that the device is substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that are intended to be marketed in the United States are required to file a 510(k) Summary if their device is not exempt from premarket notification and is not classified as a Class III device.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers should follow the FDA's guidance, including providing information about the device, its intended use, technological characteristics, and performance data, as well as comparisons to predicate devices.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to provide the FDA with relevant information to assess whether a new medical device is safe and effective by comparing it to an existing device that is already on the market.

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

The 510(k) Summary must include device identification, intended use, a description of the device and its components, comparison to predicate devices, performance testing data, and labeling information.