Get the free 510(k) Notification - accessdata fda

GiKZVY3 JA N 31 2012 A Ashok Audit) MicroCV 510(k) Notification m Uptake Calibration/Verification Set 510(k) Summary A. Submitter Alto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone:

How to fill out 510k notification - accessdata

How to fill out 510k notification - accessdata:

1. Gather all necessary information and documentation related to your medical device. This may include product specifications, labeling, design controls, manufacturing procedures, clinical data, and any other relevant documentation.
2. Access the FDA's electronic submission system, known as 'Accessdata.' Create an account if you don't already have one.
3. Navigate to the section for 510k notifications within Accessdata. Select the 'Create New Submission' option.
4. Fill out the required information in the online form, such as the device identification details, intended use, product classification, and regulatory history.
5. Provide a detailed description of the device and its intended use, including any intended indications for use and the patient population it is designed for.
6. Include any applicable performance standards, recognized consensus standards, or testing information.
7. If relevant, submit any clinical data or studies that support the safety and effectiveness of the medical device.
8. Provide a list of any predicate devices that the medical device is intended to be 'substantially equivalent' to. Include any relevant information regarding the device's similarities and differences compared to the predicate devices.
9. Upload all required supporting documents and attachments, making sure they are properly labeled and organized.
10. Review the completed submission for accuracy and completeness. Make any necessary corrections or additions before submitting it.
11. Once submitted, monitor the status of your 510k notification within Accessdata. You may receive requests for additional information or clarification from the FDA during the review process.

Who needs 510k notification - accessdata?

1. Medical device manufacturers who intend to introduce a new medical device to the U.S. market generally need to submit a 510k notification to the FDA.
2. Companies seeking clearance for modifications or changes to existing medical devices that could affect their safety or effectiveness also require a 510k notification.
3. In some cases, medical device reprocessors and specification developers may also be required to submit a 510k notification if they are involved in activities that fall under FDA regulations.

For pdfFiller’s FAQs

What is 510k notification - accessdata?

510k notification is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)). Accessdata is the FDA's database where these notifications are submitted and reviewed.

Who is required to file 510k notification - accessdata?

Any person who wants to market a Class I, II, or III device intended for human use must submit a 510k notification to the FDA unless exempt.

How to fill out 510k notification - accessdata?

The 510k notification form can be filled out electronically on FDA's Accessdata portal. The submitter must provide detailed information about the device, its intended use, technological characteristics, and compare it to a predicate device already on the market.

What is the purpose of 510k notification - accessdata?

The purpose of 510k notification is to demonstrate that a new medical device is substantially equivalent to a device already legally marketed in terms of safety and effectiveness.

What information must be reported on 510k notification- accessdata?

The 510k notification must include information about the device design, intended use, performance data, labeling, and indications for use. It should also contain a comparison to a similar legally marketed device.

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