Get the free Section 5 510k Summary 510k SUMMARY - accessdata fda

DEC Curative Medical Inc. Section 5. 510(k) Summary 510(k) SUMMARY A 510(k) Summary in accordance with the requirements of 21 CFR 807.92 is provided below. Submitter: Curative Medical Inc. 3227 Fifer

How to fill out section 5 510k summary

How to fill out section 5 510k summary:

1. Start by providing the necessary information about the medical device being submitted for clearance. This includes the device's name, intended use, and a brief description of its design.
2. Next, outline the device's substantial equivalence to legally marketed predicate devices. This involves listing specific predicate devices along with a justification for why the new device is similar in terms of intended use, design, materials, and performance characteristics.
3. Include a thorough summary of any non-clinical performance testing that has been conducted on the device. This should cover relevant aspects such as biocompatibility, sterility, electrical safety, and mechanical performance. Provide detailed results and explain how they demonstrate the device's safety and effectiveness.
4. If applicable, provide a summary of any clinical data supporting the device's safety and effectiveness. This may include clinical trials, literature reviews, or other studies. Explain the study design, participant demographics, and key findings that support the device's clearance.
5. Discuss any labeling requirements for the device, including indications for use, contraindications, warnings, and precautions. Clearly state how the device labeling complies with applicable regulations and how it provides adequate instructions for use.
6. Finally, conclude the section by summarizing the overall safety and effectiveness of the device, highlighting key points from the previous sections. Emphasize why the device should be cleared for marketing and any additional information that may be relevant.

Who needs section 5 510k summary:

1. Medical device manufacturers who are seeking clearance from the U.S. Food and Drug Administration (FDA) for a new medical device or modifications to an existing device.
2. Regulatory affairs professionals who are responsible for preparing and submitting a 510(k) application on behalf of the manufacturer.
3. FDA reviewers who will evaluate the 510(k) submission and determine whether the device meets the regulatory requirements for marketing in the United States.

For pdfFiller’s FAQs

What is section 5 510k summary?

Section 5 of a 510k submission includes a summary of the safety and effectiveness of the device being submitted for FDA approval.

Who is required to file section 5 510k summary?

The manufacturer of the medical device is required to file section 5 of the 510k summary.

How to fill out section 5 510k summary?

The manufacturer must provide a detailed summary of the safety and effectiveness data for the device being submitted.

What is the purpose of section 5 510k summary?

The purpose of section 5 of the 510k submission is to provide the FDA with a clear summary of the safety and effectiveness of the medical device.

What information must be reported on section 5 510k summary?

The section 5 510k summary must include detailed safety and effectiveness data for the medical device, along with any relevant clinical studies.

How can I send section 5 510k summary for eSignature?

When your section 5 510k summary is finished, send it to recipients securely and gather eSignatures with pdfFiller. You may email, text, fax, mail, or notarize a PDF straight from your account. Create an account today to test it.

How do I edit section 5 510k summary on an iOS device?

Yes, you can. With the pdfFiller mobile app, you can instantly edit, share, and sign section 5 510k summary on your iOS device. Get it at the Apple Store and install it in seconds. The application is free, but you will have to create an account to purchase a subscription or activate a free trial.

How do I complete section 5 510k summary on an Android device?

Complete section 5 510k summary and other documents on your Android device with the pdfFiller app. The software allows you to modify information, eSign, annotate, and share files. You may view your papers from anywhere with an internet connection.