Premarket Notification: What is 510(k)?

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For products and devices marketed to consumers and professionals in the U.S, the Federal Food, Drug, and Cosmetics Act establishes strict requirements. This includes pharmaceutical packaging, food, medical devices, and cosmetics containers.

Manufacturers must register a premarket notification with the Food and Drug Administration (FDA) before a new product can be certified as fit for market. This premarket notification is known as a 510(k) for medical devices.

A 510(k) is based on the principle of substantial equivalence, which means that the new product is the legal equivalent of a device which is classified by the FDA already. This ensures that the new product is safe and effective as another legally marketed device. This is commonly referred to as the predicate.

By comparing the new device to the predicate of the same intended use with identical technological characteristics, the FDA can establish substantial equivalence. The second element is flexible as a different technology can be employed if it does not raise different questions with regards to device effectiveness or safety.

A 510(k) may require the labeling, design, chemical composition, biocompatibility, energy demands, performance, safety and effectiveness, and various other properties as needed by distinct applications.

Testing Devices for a 510(k)

Manufacturers use various distinct methods to evaluate the various properties of a medical device for substantial equivalence before submitting a 510(k). Examples include:

  • Inductively Coupled Plasma Mass Spectrometry (ICP-MS) for ultra-precise, quantitative inorganic chemistry
  • Gel Permeation Chromatography for polymer molecular weight distribution analysis.
  • ASTM E647-15 tensile strength testing, to determine the modulus of elasticity, yield strength, ultimate tensile strength, and breaking strength of the device.
  • GC/LC-Mass Spectrometry and Pyrolysis Mass Spectrometry for polymer and polymer additive chemistry.
  • Thermogravimetric analysis for determining the thermal decomposition profile and presence of inorganic fillers.
  • ASTM F2565-13 dynamic mechanical analysis to measure fatigue crack growth rate.
  • Nuclear Magnetic Resonance (NMR) Spectroscopy for quantitative identification of small molecular substances.
  • ASTM F2695-12 3-point flexural testing for polymer and ceramic materials.

One or more of these methods may be necessary to help to determine the equivalent of a medical device for a 510(k) submission before the product can be released to market.

For manufacturers who are looking to establish the regulatory pathway for a new device, or for an existing product that is being reintroduced into the market which has been modified in such a way that either the safety or the efficiency of the device could be changed, these are key processes. This might include a material, design, or technological alteration.

510(k) Testing with Jordi Labs

Jordi Labs prides itself on its expertise and knowledge in the field of analytical chemistry. It is a world-leader in novel testing methodologies for cosmetics, medical devices, food and drug products, and liability testing.

Jordi Labs is also fully equipped to perform robust assessments of new or reintroduced devices with regards to substantial equivalence. This service is designed to help the user prepare a 510(k) submission against available public data and pre-defined FDA guidelines.

Jordi Labs has supported 510(k) premarket notifications of medical devices and surgical instruments and has a breadth of experience in establishing leachables and extractables.

This information has been sourced, reviewed and adapted from materials provided by Jordi Labs.

For more information on this source, please visit Jordi Labs.

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