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FDA 510k for Medical Device

A US 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 Application (PMA) is not required.

 

Most of the class I devices are exempt from 510(k) requirements. During the review of the 510(k) file, if the FDA finds the device as Substantially Equivalent (SE), the FDA will give the clearance with a ‘k’ number.

FDA 510k Process Chart

How to decide on FDA 510k

  1. Identify the New Device and the Predicate Device
  2. If the predicate device is legally marketed, then go to step 3. If not, then not substantially equivalent and 510 k not possible
  3. Check the consistency of the labeling and IFU statements
  4. If the intended use of both devices is not the same, then not substantially equivalent and 510 k not possible. If the same go to step 5
  5. Review the features of the devices, design, materials and energy source, if applicable
  6. If the technological characteristics of both devices are not the same, then go to step 7. If same, then substantially equivalent and apply for FDA 510k.
  7. Check if the differences in the technological characteristics raise any kind of safety and effectiveness questions
  8. If these differences raise different safety and effectiveness questions, then not substantially equivalent and 510 (k) not possible. If not, go to step 9
  9. Propose scientific methods for evaluating new/ different characteristics’ effect
  10. If scientific methods for evaluating new/ different characteristics are acceptable, then evaluate the performance data to demonstrate substantial equivalence. If not acceptable, then not substantially equivalent and 510k not possible.

Types of US FDA 510 k

1. Abbreviated FDA 510k

  • Abbreviated 510k is appropriate when the FDA guidance exists for specific medical devices, special controls are available for the demonstration of compliance and any voluntary FDA recognized Consensus Standards are available.
  • It must include the main elements of the Traditional 510k with the summary report on the use of the FDA guidance documents and/or special controls or declaration of conformity to the FDA recognized standards with the data that supports.

Through in abbreviated, the subject medical device has to prove substantial equivalence with the legally marketed FDA cleared medical device.

2. Traditional 510k

Traditional 510(k) is the original submission which normally has to be provided by the medical devices which require the FDA clearance by 510k submission according to the regulation 21 CFR 807.

 

It can also be used to submit if there is any change in the previous FDA 510(k) cleared device. FDA generally takes 90 days for the traditional 510 k Submission.

3. Special 510k

Special 510(k) is the submission in which already FDA cleared medical device has some changes which don’t require the FDA review of complete documentation, but only the summary.

These changes include design changes, labeling changes to the existing device including certain indication of use. But those changes should not affect the safety and the performance of the device and well- established methods to evaluate the changes.

How to prepare and submit FDA 510k?

Depending on the three types of FDA 510k i.e., traditional, abbreviated, and special, there are respective ways to prepare the 510k. Once the legal submitter chooses the type, there are specific FDA guidances available for the type of 510k.

 

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 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 510k documents
  • For the Abbreviated clearance, locate the FDA Special Controls and/or voluntary consensus standards, if any
  • Prepare the contents of the selected 510k in the specific FDA format
  • Make it to the e-copy for submission
  • Submit the user fee

FDA 510K 1

What is Substantial Equivalence?

FDA 510 (k) requires demonstration of Substantial Equivalence(SE) to another device of similar intended use, already cleared 510(k) and legally sold in the U.S. SE means that the 510k applied device is at least as safe and effective as the predicate device.

Major criteria of Substantial Equivalence determination

  1. same intended use as the predicate
  2. same technological characteristics
  3. different technological characteristics and does not raise different questions of safety and effectiveness

SE is based on establishing intended use, design, safety, chemical composition, biocompatibility, performance, standards, materials, manufacturing process, effectiveness, labeling, and other characteristics, as applicable.

What are FDA guidance documents?

FDA Guidance Documents include the FDA recommendations to the medical device industry. Device-specific guidance documents will give specific information to be included for the device’s 510 k Submission.

 

An abbreviated 510k submission relies on the guidance documents with a summary of the information on how the guidance document could be used to demonstrate the substantial equivalence with the predicate device.