FDA 510k Clearance for Medical Device and IVDs

FDA 510k – An Overview

FDA 510k is a file containing sufficient information about a device to demonstrate that the medical device is at least as safe and effective as legally marketed devices that are not subjected to PMA. Organizations planning to launch Class I, II, and III devices in the United States intended for human use must submit a 510(k) if pre-market approval is not required.

 

Most class 1 devices are exempt from FDA 510k requirements. During the review of the file, if the FDA finds the device to be substantially equivalent, it will grant the FDA 510k clearance for medical devices with a ‘(k)’ number.

 

We offer technical and scientific assistance in identifying a suitable predicate device, regulation number, and device code, along with file drafting, e-copy conversion, and submission through the US Agent service. Few manufacturers opt for Q submission before final submission.

Role of I3CGlobal Consultants

As a prominent FDA 510k Consultants on a global scale, we have gained the trust of more than 350 plus manufacturers and specification developers. Our team consists of highly skilled subject-matter experts, assuring timely file preparation for 510(k) clearance irrespective of the manufacturer’s size or the regulatory knowledge of their internal team.

 

With an impressive 85% success rate, a track record of over 350+ clearances worldwide, and a history of serving more than 150+ manufacturers and specification developers since 1999, we proudly stand out from others in terms of quality and service cost.

 

Our dedication goes beyond mere verbal or email communication; we painstakingly assemble the complete files on behalf of our clients and take full responsibility until the 510k approval is obtained.

F

DA 510k Predicate Device

The term Predicate Device refers to a FDA 510k or PMA-cleared and legally marketed device in the USA with the same (a) intended use, (b) indications for use, and (c) similar technological characteristics as the device in question. It is crucial to note that the predicate device must be a single unit, if possible, and currently available in the USA market without any product recalls in the past years.

Substantial Equivalence Definition

It is a must to demonstrate substantial equivalence to a legally US-marketed device with similar intended use. Proving substantial equivalence to the reference device affirms that the subject device is as safe and effective as the predicate device. The key criteria for determining Substantial Equivalence include establishing similarity are the following, but are not limited to

 

  • Intended use,
  • Design,
  • Safety,
  • Adherence to standards,
  • Labelling,
  • Biological Compatibility,
  • Performance characteristics,
  • Materials used in the construction/ chemical composition,
  • Manufacturing Methods,

FDA 510k Predicate Device

The term Predicate Device refers to a FDA 510k or PMA-cleared and legally marketed device in the USA with the same (a) intended use, (b) indications for use, and (c) similar technological characteristics as the device in question. It is crucial to note that the predicate device must be a single unit, if possible, and currently available in the USA market without any product recalls in the past years.

Substantial Equivalence Definition

It is a must to demonstrate substantial equivalence to a legally US-marketed device with similar intended use. Proving substantial equivalence to the reference device affirms that the subject device is as safe and effective as the predicate device. The key criteria for determining Substantial Equivalence include establishing similarity are the following, but are not limited to

 

  • Intended use,
  • Design,
  • Safety,
  • Adherence to standards,
  • Labelling,
  • Biological Compatibility,
  • Performance characteristics,
  • Materials used in the construction/ chemical composition,
  • Manufacturing Methods,

 

Get more Information : https://www.i3cglobal.com/fda-510k/

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