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A summary of safety and effectiveness information for the NucliSENS EasyQ® MRSA assay, a molecular diagnostic test for detecting methicillin-resistant Staphylococcus aureus (MRSA) from nasal swabs.

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Gather relevant data about the device, including specifications, intended use, and design.
2. Identify the predicate device that is most similar to your device and collect its 510(k) number.
3. Prepare comparative data that demonstrates substantial equivalence to the predicate device.
4. Draft the 510(k) Summary, including device description, indications for use, technological characteristics, and performance data.
5. Include labeling information, stating how your device will be marketed and any potential warnings or contraindications.
6. Review the 510(k) Summary for accuracy, completeness, and compliance with FDA requirements.
7. Submit the 510(k) Summary electronically via the FDA's eSubmitter or specified platform, including all necessary documents and payment of fees.

Who needs 510(k) Summary?

1. Manufacturers of medical devices intending to market devices that are not significantly different from an already marketed device.
2. Companies looking to gain FDA clearance for new devices by demonstrating substantial equivalence to existing devices.
3. Organizations seeking to ensure compliance with regulatory standards before launching medical devices in the U.S. market.

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?

A 510(k) Summary is a document submitted to the FDA that provides information about a medical device, demonstrating that it is safe and effective for its intended use, and 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 and claim that their device is substantially equivalent to a previously cleared device must file a 510(k) Summary.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers need to include information such as device name, description, indications for use, technological characteristics, performance data, and labeling, ensuring they demonstrate substantial equivalence to a predicate device.

What is the purpose of 510(k) Summary?

The purpose of a 510(k) Summary is to provide the FDA with enough information to assess the device's safety and effectiveness and to determine whether it is substantially equivalent to a previously approved device.

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

The information that must be reported includes device identification, manufacturer details, intended use, technological features, comparisons to predicate devices, performance studies, and user labeling.