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510(k) Frequently Asked Questions

What you mean by proposed predicative device? Is it necessary to include in 510(k)?

Proposed predicate device refers to a lawfully marketed, 510(k) cleared product that is used to determine substantial equivalence of the proposed/new device for 510(k) Submission.

 

Yes, FDA submission is required because the 510(k) clearance is determined by the proposed device’s substantial equivalence to a legally marketed device. A comparison table and discussion of the similarities and differences of your device compared to one or more predicate devices to which you are claiming equivalence is an important aspect of the 510(k).

Do you have a ready to edit and use template for Acceptance Checklist for Abbreviated 510(k) Submission?

Do you have a ready to edit and use template for 510(k) summary?

Yes. The parameters and the sections may vary based on the device requirements. Click to know more https://www.i3cglobal.store/templates/

What do you mean by Truthful and Accurate Statement? Is it a part of 510(k) File?

Truthful and Accurate Statements must be a part of all 510(k) submissions. In this section, the submitter gives a statement that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.

Is Summary and Certification a part of 510(k) File? Is it applicable for all devices?

Only class III devices that do not require a PMA submission should have a summary and certification, and they should be included in the 510(k) documentation. The Class III Summary is a list of issues related to the device’s safety and effectiveness.

 

It must provide a complete description of information on the item as well as other lawfully marketed devices, as well as citations to such data if applicable. I devised this part is not applicable for classes II and Class, and can insert the statement “This section does not apply” or “N/A” under that heading.

 

Buy read to use templates: https://www.i3cglobal.store/templates/

What is Declaration of Conformity? Is it part of FDA 510(k)?

The purpose of a declaration of conformity is to offer information on the use of voluntary consensus standards, such as any declarations of conformity or the rationale for their wide usage in traditional submissions. Whereas for short 510(k) submissions, a summary report that details how the device conforms with the special controls associated with the particular device type or that are indicated in any applicable device-specific guidelines is required.

 

For both regular and abbreviated 510(k) submissions, the declaration of conformance section is appropriate. Buy read to use templates: https://www.i3cglobal.store/templates/

Explain the 510(k) requirement for the Biocompatibility. What is expected by a reviewer?

If the medical device involves components that come into direct or indirect touch with tissue, the FDA requires that the biocompatibility of tissue-contacting materials be evaluated. Biocompatibility testing is carried out in accordance with ISO 10993-1.
Even though the subject device and the predicate device have the same material and construction, biocompatibility studies must be conducted to demonstrate the device’s biological safety.

 

 

The reviewer will require information on the testing process and reports in detail. The protocol must comprise the study title and standard, preparation of the test article, thorough test method-positive and negative controls, test parameters and acceptance criteria, and analysis of the results. The report must include an analysis of the test results, conclusions drawn from the data, a photograph of the gadget, and so on.

Is Sterilization validation mandatory for 510(k)?

Only sterile medical devices require sterilization validation. Non-sterile medical devices may not fall under the sterility provision. For Sterility Information in Premarket Notification 510(k) Submissions for Devices Labeled as Sterile and Reprocessed Single-Use Medical Devices, the FDA issued two guidelines.

 

https://www.fda.gov/media/74445/download
https://www.fda.gov/media/71482/download

Is Shelf-Life studies part of FDA 510(k) Documentation?

FDA 510(k) documentation includes shelf-life studies. If you want to claim a shelf-life span for your device, you’ll need to keep the necessary studies and reports on hand. Even if accelerated studies are acceptable, FDA usually prefers real-time stability studies. To confirm the safety and effectiveness, the FDA required the performance test to be conducted following the real-time/accelerated research.

 

If the device is supplied sterile, sterilization and packaging validations should be performed after the shelf-life term.

What you mean by Indication of Use? Intended use?

The purpose of your device is defined by its intended use. It specifies what your item is supposed to perform based on the claims mentioned on the packaging.

 

The reasons or conditions under which the device would be utilized are defined by the indications of use. Under indications for use, the details of the disease or condition that can be diagnosed, avoided, treated, or alleviated by using the device, as well as the patient group for which the device is designed, are listed.

What type of Animal Testing is required to be a part of FDA 510(k) documentation?

Animal studies were used to evaluate the device’s early evidence of device safety, potential performance in a live system, and the biological reaction that a live system would mount to the device.

What type of Clinical Information is part of FDA 510(k) submission?

The clinical study is conducted to collect data to establish the safety and effectiveness of investigational devices.

What is the purpose of Financial Certification or Disclosure Statement in 510(k) Documentation?

If the section does not apply, but the statement “This section does not apply” or “N/A” under that heading if it is part of the FDA 510(k).

 

Any applicant who files a marketing application for a human medication, biological product, or device, as well as covered clinical studies, is subject to the requirements in this section. Where the application either contracted with one or more clinical investigators to perform the research or submitted studies completed by others who were not under contract to the applicant, the applicant is responsible for making the necessary certification or disclosure statement.

What is the difference between Executive Summary and 510(k) summary?

The FDA 510(k) requirements include a mandated executive summary and 510(k) summaries. https://www.i3cglobal.store/templates/