Get the free Section 5 510Ok Summary Aspire CR for Mammography ORm - accessdata fda

DEC 8 2011 Section 5 510O(k) Summary Aspire CR for Mammography (ORM) AFDM System This Section contains: 510(k) Summary Aspire CRM AFDM System 510(k) Submission Page 43 of 858 Page Intentionally Blank

How to fill out section 5 510ok summary

How to fill out section 5 510(k) summary:

1. Start by providing a clear and concise description of the device, including its intended use and technological characteristics.
2. Include a comparison to a legally marketed predicate device that demonstrates substantial equivalence.
3. Clearly identify any differences between the new device and the predicate device, explaining why these differences do not affect the safety and effectiveness of the new device.
4. Provide a summary of non-clinical and clinical performance testing conducted on the new device, including any relevant test protocols and results.
5. Include a discussion of any potential risks associated with the new device and describe the measures taken to mitigate these risks.
6. Provide a summary of any relevant labeling, including instructions for use, warnings, and contraindications.
7. Ensure that all required information, such as device classification, manufacturer information, and regulatory references, is accurately provided in the designated sections.
8. Review the completed section 5 510(k) summary for clarity, accuracy, and completeness before submission.

Who needs section 5 510(k) summary?

1. Medical device manufacturers who are seeking clearance or approval for their new medical devices from the U.S. Food and Drug Administration (FDA).
2. Regulatory affairs professionals who are responsible for preparing and submitting 510(k) applications to the FDA on behalf of the device manufacturers.
3. Healthcare professionals who are involved in the development and evaluation of new medical devices and need to understand the documentation required for FDA clearance or approval.

For pdfFiller’s FAQs

What is section 5 510ok summary?

Section 5 510(k) summary is a brief overview of the safety and effectiveness of a medical device that is submitted to the FDA for premarket clearance.

Who is required to file section 5 510(k) summary?

Manufacturers of medical devices seeking FDA premarket clearance are required to file a section 5 510(k) summary.

How to fill out section 5 510(k) summary?

To fill out a section 5 510(k) summary, manufacturers must provide information on the device's intended use, technological characteristics, and performance data.

What is the purpose of section 5 510(k) summary?

The purpose of a section 5 510(k) summary is to demonstrate the substantial equivalence of the medical device to a legally marketed device.

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

Information such as device description, indications for use, performance data, and comparison to a predicate device must be reported on a section 5 510(k) summary.

Can I create an eSignature for the section 5 510ok summary in Gmail?

You may quickly make your eSignature using pdfFiller and then eSign your section 5 510ok summary right from your mailbox using pdfFiller's Gmail add-on. Please keep in mind that in order to preserve your signatures and signed papers, you must first create an account.

How do I complete section 5 510ok summary on an iOS device?

pdfFiller has an iOS app that lets you fill out documents on your phone. A subscription to the service means you can make an account or log in to one you already have. As soon as the registration process is done, upload your section 5 510ok summary. You can now use pdfFiller's more advanced features, like adding fillable fields and eSigning documents, as well as accessing them from any device, no matter where you are in the world.

How do I fill out section 5 510ok summary on an Android device?

Use the pdfFiller mobile app to complete your section 5 510ok summary on an Android device. The application makes it possible to perform all needed document management manipulations, like adding, editing, and removing text, signing, annotating, and more. All you need is your smartphone and an internet connection.