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FDA 510k Clearance
FDA 510k is a file containing sufficient information about a device to demonstrate that the medical device is at least as safe and effective, similar to that of the legally marketed device that is not subjected to PMA.
Organizations planning to launch Class I, Class II, and Class III Medical Devices in the United States intended for human use must submit US FDA 510(k) if Pre-market Approval (PMA) is not required.
Most of the class I devices are exempt from 510k requirements. During the review of the 510k file, if the FDA finds the device as Substantially Equivalent (SE), the FDA will give the clearance with a ‘k’ number.
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What are Predicate Devices?
The term “Predicate Device” means a 510k or PMA cleared and legally marketed device in the USA, with the same (a), Intended Use (b) Indications for Use (c) Similar technological characteristics to the device in question.
It is important to know Predicate Device must be a single unit preferable and presently available in the USA market without any product recalls in the past years.
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What is Substantial Equivalence?
It a must to demonstrate Substantial Equivalence (SE) to a legally US marketed device of similar intended use. Meeting Substantial Equivalence to the applied device proves the device is as safe and effective as the predicate device.
Following are the major criteria of Substantial Equivalence determination.
SE is based on establishing intended use, design, safety, chemical composition, biocompatibility, performance, standards, materials, manufacturing process, effectiveness, labeling, and other characteristics, as applicable.
- same intended use as the predicate
- same technological characteristics
- different technological characteristics and does not raise different questions of safety and effectivenes
Types of FDA 510k's
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Special FDA 510k submission is for already 510k cleared device has some changes which don’t require the full review, but only the summary document.
These changes include indications of use, design, and labeling, but also those changes should not affect the safety and the performance of the new modified device and well-established methods to evaluate the changes.
Depending on the three types of FDA 510k i.e., traditional, abbreviated, and special, there are respective ways to prepare the 510 k. Once the legal submitter chooses the type, there are specific FDA guidances available for the type of 510 k.
Among the three, traditional is the basic and can be followed under any circumstances. In all types, the submitter must prove the substantial equivalence of the subject device with the legally marketed FDA cleared device (predicate device).
This includes a comparison of the intended use, technological, performance, biological, mechanical, and electrical characteristics of the devices.
If there are differences in any of the characteristics, it must be proved that those differences will not affect the safety and performance of the device and must propose scientific methods to evaluate the same with the performance data.
The FDA 510k documentation is not a “form” but it shall include all the information required as per the regulation 21 CFR 807.87. It includes the steps as given below:
- Find a predicate device (legally marketing FDA cleared device)
- Locate the FDA guidance document to prepare the 510 k documents
- For the Abbreviated clearance, locate the FDA Special Controls and/or voluntary consensus standards, if any
- Prepare the contents of the selected 510(k) in the specific FDA format
- Make it to the e-copy for submission
- Submit the user fee
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Inhouse US Agent for "Q" Submission and final submission and inhouse experts for Interaction with FDA reviewer
One of the largest regulatory outsourcing companies in the world packed with the best performing and qualified subject expert team. No matter how big or small the manufacturer is, but someone with good device knowledge joins hands with our team, we assure the rest with 510(k) clearance on time.
Our service offerings are not just by verbal or email communication, we develop the complete 510 k file on behalf of the client and take the whole responsibility till FDA 510k clearance.
Medical Device FDA Registration and Listing for Class I devices and devices with 510k number. World most economic FDA 510k Services.
FDA 510k Certification
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Medical Device Regulatory professionals dedicated to European and USA FDA Regulations. Having in this field for more than 20+ years made us know various types of devices and multiple tasks involved in each device.
Our economic and fixed pricing that suits large and small manufactures with an added benefit of assured service makes us the top service provider for 510k Certification and Clearances.
Frequently Asked Questions
What you mean by proposed predicative device? Is it necessary to include in 510(k)?
The predicate device is a legally marketed, 510(k) cleared device used to determine substantial equivalence of the proposed/new device for510(k) Submission is called proposed predicate device.
Yes, it is necessary to submit to FDA, as the substantial equivalence of the proposed device with a legally marketed device decides the 510(k) clearance. It is a critical part of 510(k) you should include 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 equivalency.
Do you have a ready to edit and use template for Acceptance Checklist for Abbreviated 510(k) Submission?
Using the Acceptance Checklist appropriate to the submission type (traditional, abbreviated, or special), within 15 calendar days of receipt of the 510(k), FDA staff should answer each question for the elements identified as RTA (Refuse to Accept) items.
We do have the PDF version of the acceptance checklist for traditional as well as abbreviated. It can be used internally to ensure all the sections are included in the documentation during 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.
*Attached the 510(k)-summary template.
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.
*We do have a ready-to-edit copy and the template is attached.
Is Summary and Certification a part of 510(k) File? Is it applicable for all devices?
The summary and certification are applicable for only class III devices that are not called for PMA submission, and it should be a part of 510(k) documentation. The Class III Summary is a summary of the problems associated with the device’s safety and effectiveness.
It shall contain the whole summary of information regarding the device and other legally marketed devices and the citation of such data if applicable. For class II and Class, I devise this section is not applicable and can include the statement as “This section does not apply” or “N/A” under that heading.
*Template is prepared and attached in the folder
What is Declaration of Conformity? Is it part of FDA 510(k)?
Declaration of conformity is to provide information relating to the use of voluntary consensus standards, including any declarations of conformity or the basis of the general use of such standards for the traditional submissions.
Whereas for abbreviated 510(k) submissions to provide the information regarding the use of standards, or a summary report that describes how the device complies with the special controls associated with the particular device type or that is recommended in any relevant device-specific guidance.
Declaration of conformity is a suitable section for both traditional and the abbreviated 510(k) submissions.
Explain the 510(k) requirement for the Biocompatibility. What is expected by a reviewer?
FDA recommends the evaluation of biocompatibility of tissue contacting materials if the medical device contains components that come into direct or indirect contact with tissue. Biocompatibility testing is performed as per the standard ISO 10993-1.
The biocompatibility studies shall perform even if the material and construction of the subject device and predicate device are the same, to prove the biological safety of the device.
The reviewer will need information regarding detailed testing protocol and reports. The protocol shall include the details of study title and standard, the test article preparation, detailed test method- positive and negative controls, test parameters and acceptance criteria, analysis of results. The report shall include the analysis of test results, conclusions made from the test result, device photograph, etc.
Is Sterilization validation mandatory for 510(k)?
Sterilization validation is required for only sterile medical devices. The section for sterility can be not applicable for non-sterile medical devices.
FDA released two guidance for the Sterility Information in Premarket Notification 510(k) Submissions for Devices Labelled as Sterile and Reprocessed Single-Use Medical Devices.
Is Shelf-Life studies part of FDA 510(k) Documentation?
Shelf-life studies are part of FDA 510k documentation. If you are claiming any shelf-life period to your device, then the necessary studies and reports shall keep in submission.
Usually, FDA prefers Real-time stability studies, even if the accelerated studies are accepting. FDA required the performance test also conduct after the real-Time/accelerated study to prove the safety and effectiveness.
If the device is supplied sterile then it's recommended to perform the sterilization and the packaging validations after the shelf-life period.
What you mean by Indication of Use? Intended use? explain both in details.
Intended use define the purpose of your device. It indicates what your device is meant to do as per the claims being made on the labeling.
Indications of use define the reasons or conditions under which the device would be used. The details of the disease or condition which can be diagnosed, prevented, cured, or mitigated by the use of the device along with the patient population for which the device is intended comes under indications for use.
What type of Animal Testing is required to be a part of FDA 510(k) documentation?
The animal studies utilized for the assessment of the device's initial evidence of device safety, their potential performance when used in a living system, and the biological response that a living system may mount towards the device. For more information visit our blog section.
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?
A Financial Certification or Disclosure Statement must include in 510(k).
It should be as part of the FDA 510(k), if the section does not apply then include the statement “This section does not apply” or “N/A” under that heading.
The requirements in this part apply to any applicant who submits a marketing application for a human drug, biological product, or device and who submits covered clinical studies. The applicant is responsible for making the appropriate certification or disclosure statement where the applicant either contracted with one or more clinical investigators to conduct the studies or submitted studies conducted by others, not under contract to the applicant.
What is the difference between Executive Summary and 510(k) summary?
Executive summary and the 510(k) summaries are part of FDA 510(k) requirements and are mandatory. For more details visit our blog section.
*Template available for purchase.