Different parts or sections included into the 510k application for class 2 medical device regulatory approval

1. Short overview of 510K
submission
By -Rohit.

2. Step by step explanation of different part
• Part A)
Medical device user fee cover sheet (FDA form 3601)
• Part B)
CDRH premarket review submission coversheet (FDA Form 3514)

3. Part C) 510K cover letter
The cover letter consist of following information
- Type of 510k submission
- Contact person name and contact details
- Preference related to confidentiality
- Class of device
- Review panel
- FDA product code
- Document related to previous correspondence with FDA(IDE)

4. Part 4) Indication for use statement
Part 5) 510K summary
• FDA will make a 510(k) summary of the safety and effectiveness data available to the
public within 30 days of the issuance of a determination that the device is substantially
equivalent to another device.”
• have to prove substantial equivalence of the indications for use between your device
and the predicate device.
• Should not include too much details (30days published)

5. • Part 6)Truthful and Accuracy Statement
It’s a statement that certifies that all of the information included is truthful and accurate and
that nothing has been omitted.
• Part 7) Class III Summary and Certification might be just as easy to comple
• If you have a class II device, which is going to be most of the 510(k) submissions, the section is
going to consist of a single sentence: “This device is not a class III device.”
• Part 8) Final certification or disclosure statement
• No clinical studies were performed to test this device.” no certification is required or no clinical
study is not generally performed for class 2 medical devices
• Part 9) Declarations of Conformity and Summary Reports
• It is going to vary in length and content, depending on your medical device and the type of
510(k) you are submitting.
If you followed a device specific guidance, you should include a summary report of the testing.

6. Part 10) Executive summary
• For these design control documentation, Risk management documentation and establishing
quality management system is very important .
• Describe the medical device more concisely compare to predicate and summarize all testing.
• This executive summary is not released into internet unlike 510k summary
Part 11) Brief description about the device
• Compare the device with the predicate device
• Summarize all the testing performed for the device

7. Part 12) Substantial equivalence of device discussion
• Use of the comparative tool for equivalence of device.
Part 13) proposed labelling
• Consider the design output for development of label
• Paste the copy of device labelled
• It contain the information IFU,Patient labelling an package insert

8. Part 14) sterilization and shelf life
No need of use if device is non sterile
if you plan to make a shelf life claim, you will be expected to support this with applicable product
testing to demonstrate performance over the stated shelf life.This often includes accelerated age
testing.
Part 15) Biocompatibility
If you’ve got anything that’s in direct or indirect patient contact, this section is important.
In the FDA Refuse to Accept (RTA) checklist, it very clearly states that you need to include the
protocol and reports.
Part 16 and 17 consist of software and electronic section
(If your device doesn’t have any software or electrical components, then we can to skip this part)

9. Part 18) Performance testing of device (Bench)
Comparing the performance characteristics of your device to the predicate device
Part 19) Performance testing on Animal
Part 20) clinical performance testing of medical device –
This may not required for class 2 device or 510k submission
References-
-USFDA.gov.in
-Greenlight guru,s guide