A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed medical device (21 CFR 807.92(a)(3)) that is not subject to PMA.1


The key elements that the FDA uses to evaluate substantial equivalence are:

  • Same intended use as the predicate device
  • Same technological characteristics as the predicate device
  • At least as safe and effective as predicate device

RQM+ Lab Services can assist you in the testing and submission of your 510(k), as well as answering the following questions about your device from the FDA’s guidance document.

  • Do the devices have the same technological characteristics?
  • Do the different technological characteristics of the devices raise different questions of safety and effectiveness?
  • Are the methods acceptable?
  • Does the data demonstrate substantial equivalence?

For more information on the 510(k) process, read the FDA’s guidance document here.

Some of the techniques that RQM+ Lab Services deploys in the testing to support a 510(k) include:

ASTM E647-15 Tensile Properties
ASTM F2565-13 Fatigue Crack Growth Rate
ASTM F2695-12 Material Properties
Pyrolysis Mass Spectrometry Qualitative Polymer & Additive Chemistry
GC/LC-Mass Spectrometry Quantitative/Qualitative Polymer Additive Chemistry
Gel Permeation Chromatography Polymer Molecular Weight Distribution
ICP-Mass Spectrometry Quantitative Inorganic Chemistry
Nuclear Magnetic Resonance Spectroscopy Functionalization/Crosslink Ratio
Thermogravimetric Analysis Filler Content


Related Standards

  • 510(k)
  • Food & Drug Administration

We are passionate about your success. Tell us more about your regulatory and quality needs to learn about how we can help.

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