Get the free Special 510(k) Summary - accessdata fda
Show details
This document provides notification of modification to the Total Bilirubin Special test system, detailing differences, similarities, and regulatory compliance related to the device.
We are not affiliated with any brand or entity on this form
Get, Create, Make and Sign special 510k summary
Edit your special 510k summary form online
Type text, complete fillable fields, insert images, highlight or blackout data for discretion, add comments, and more.
Add your legally-binding signature
Draw or type your signature, upload a signature image, or capture it with your digital camera.
Share your form instantly
Email, fax, or share your special 510k summary form via URL. You can also download, print, or export forms to your preferred cloud storage service.
Editing special 510k summary online
In order to make advantage of the professional PDF editor, follow these steps below:
1
Create an account. Begin by choosing Start Free Trial and, if you are a new user, establish a profile.
2
Prepare a file. Use the Add New button to start a new project. Then, using your device, upload your file to the system by importing it from internal mail, the cloud, or adding its URL.
3
Edit special 510k summary. Replace text, adding objects, rearranging pages, and more. Then select the Documents tab to combine, divide, lock or unlock the file.
4
Save your file. Select it from your list of records. Then, move your cursor to the right toolbar and choose one of the exporting options. You can save it in multiple formats, download it as a PDF, send it by email, or store it in the cloud, among other things.
pdfFiller makes dealing with documents a breeze. Create an account to find out!
Uncompromising security for your PDF editing and eSignature needs
Your private information is safe with pdfFiller. We employ end-to-end encryption, secure cloud storage, and advanced access control to protect your documents and maintain regulatory compliance.
How to fill out special 510k summary
How to fill out Special 510(k) Summary
01
Identify the device and its Predicate Device.
02
Gather data supporting the substantial equivalence claim.
03
Complete the Special 510(k) Summary form, detailing device information.
04
Include a description of the changes made compared to the predicate.
05
Provide performance testing data if applicable.
06
Ensure all relevant labeling information is included.
07
Review the summary for completeness and accuracy.
08
Submit the completed summary to the FDA for review.
Who needs Special 510(k) Summary?
01
Manufacturers of medical devices that have made modifications to an existing device.
02
Companies seeking to demonstrate substantial equivalence to a predicate device.
03
Entities looking to expedite their premarket submission process.
Fill
form
: Try Risk Free
People Also Ask about
What is the content of a special 510k?
Most 510(k)s will include some type of performance data. The extent of performance data will depend on the complexity of the device and its intended use and indications. Performance data should be provided to help demonstrate SE of your device to one or more legally marketed devices (predicate device).
What is a 510k statement?
FDA Clearance. A 510(k) is a premarket submission made to the FDA. It is called a 510(k) because it refers to that section of the Food, Drug and Cosmetic Act. It is the regulatory pathway mostly utilized for Class II devices that hope to be substantially equivalent to another device which is currently legally marketed.
What is the rejection rate for 510k?
The FDA 510(k) submission process is a critical gateway for medical device manufacturers seeking approval for their products in the United States. However, a concerning trend has emerged – a staggering 25% of these submissions are facing rejection due to lack of completeness.
What is the difference between 510k and special 510k?
The difference between the three types of 510(k) submissions comes down to how you prove substantial equivalence: Traditional 510(k): Prove substantial equivalence to a legally marketed predicate device. Special 510(k): Prove substantial equivalence to your own previously cleared device.
What is the difference between 510k and special 510k?
The difference between the three types of 510(k) submissions comes down to how you prove substantial equivalence: Traditional 510(k): Prove substantial equivalence to a legally marketed predicate device. Special 510(k): Prove substantial equivalence to your own previously cleared device.
How long does it take to get approved for special 510k?
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.
For pdfFiller’s FAQs
Below is a list of the most common customer questions. If you can’t find an answer to your question, please don’t hesitate to reach out to us.
What is Special 510(k) Summary?
The Special 510(k) Summary is a type of submission to the FDA that allows medical device manufacturers to notify the agency about changes to a device that do not affect its intended use or alter its fundamental scientific technology.
Who is required to file Special 510(k) Summary?
Manufacturers of medical devices that already have 510(k) clearance and are making changes to their devices that do not significantly affect their safety or effectiveness are required to file a Special 510(k) Summary.
How to fill out Special 510(k) Summary?
To fill out a Special 510(k) Summary, manufacturers must provide information about the device, including a detailed description of the changes made, a summary of the reason for the changes, and results of any tests performed to validate those changes.
What is the purpose of Special 510(k) Summary?
The purpose of the Special 510(k) Summary is to facilitate the timely review of modifications to existing devices while ensuring that they continue to meet safety and effectiveness standards set by the FDA.
What information must be reported on Special 510(k) Summary?
The information that must be reported on a Special 510(k) Summary includes the device name, 510(k) number of the original device, a description of the modification, intended use of the modified device, and any performance testing results that demonstrate the device's safety and effectiveness.
Fill out your special 510k summary online with pdfFiller!
pdfFiller is an end-to-end solution for managing, creating, and editing documents and forms in the cloud. Save time and hassle by preparing your tax forms online.
Special 510k Summary is not the form you're looking for?Search for another form here.
Relevant keywords
Related Forms
If you believe that this page should be taken down, please follow our DMCA take down process
here
.
This form may include fields for payment information. Data entered in these fields is not covered by PCI DSS compliance.
