Get the free 510k Summary of Safety and Effectiveness APR 1 8 2014 - accessdata fda

K133397 510(k) Summary of Safety and Effectiveness page 115 APR 1 8 2014 In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the POD Plagiocephaly Arthrosis Device is provided

How to fill out 510k summary of safety

1. Start by gathering all relevant information and data about the medical device for which you are submitting the 510k summary of safety. This may include technical specifications, clinical trial results, and any adverse event reports.
2. Provide a clear and concise description of the medical device, including its intended use, design features, and operating principles. Include any performance characteristics and limitations that may be relevant to its safety.
3. Detail the potential risks associated with the device and the steps taken to mitigate those risks. This may include information on device labeling, user instructions, and any recommended precautions or warnings.
4. Summarize the results of any preclinical and/or clinical testing conducted to evaluate the safety of the device. Include detailed information on the study design, population, endpoints, and any adverse events or complications observed.
5. If applicable, provide information on any previous versions or iterations of the device, noting any changes or improvements made to enhance safety. Describe how these changes have been validated and their impact on device performance.
6. Include a summary of any post-market surveillance activities conducted, such as complaint investigations, device tracking, or post-market clinical studies. Highlight any safety concerns or corrective actions taken based on these activities.
7. Finally, ensure that all required sections and information are included as per the regulations outlined by the respective regulatory body, such as the FDA in the United States.

The 510k summary of safety is typically required for medical device manufacturers who are seeking clearance from regulatory bodies such as the FDA to market their devices in the United States. It provides a comprehensive overview of the device's safety profile, addressing potential risks and outlining the steps taken to mitigate them. This summary is crucial for regulatory authorities to assess the safety and effectiveness of the device before granting market clearance.

For pdfFiller’s FAQs

What is 510k summary of safety?

The 510k summary of safety is a document that summarizes the safety and effectiveness of a medical device for FDA review.

Who is required to file 510k summary of safety?

Manufacturers of medical devices seeking FDA approval through the 510k process are required to file a summary of safety.

How to fill out 510k summary of safety?

The 510k summary of safety should be filled out by providing detailed information about the device, its intended use, safety features, and any clinical data supporting its safety and effectiveness.

What is the purpose of 510k summary of safety?

The purpose of the 510k summary of safety is to demonstrate to the FDA that the medical device is safe and effective for its intended use.

What information must be reported on 510k summary of safety?

The 510k summary of safety must include information about the device design, materials used, biocompatibility, sterilization methods, and any clinical testing results.

How can I modify 510k summary of safety without leaving Google Drive?

By combining pdfFiller with Google Docs, you can generate fillable forms directly in Google Drive. No need to leave Google Drive to make edits or sign documents, including 510k summary of safety. Use pdfFiller's features in Google Drive to handle documents on any internet-connected device.

Can I create an electronic signature for signing my 510k summary of safety in Gmail?

You may quickly make your eSignature using pdfFiller and then eSign your 510k summary of safety 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 can I edit 510k summary of safety on a smartphone?

The pdfFiller apps for iOS and Android smartphones are available in the Apple Store and Google Play Store. You may also get the program at https://edit-pdf-ios-android.pdffiller.com/. Open the web app, sign in, and start editing 510k summary of safety.