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  7. Component and Device Documentation Examples for Test Articles or Previously Marketed Devices
  1. Biocompatibility Assessment Resource Center

Component and Device Documentation Examples for Test Articles or Previously Marketed Devices

This page provides examples illustrating possible approaches to documenting how a test article compares to the proposed medical device in its final finished form; other approaches may also be acceptable. Note that these are generalized examples to demonstrate documentation and do not necessarily account for every possible consideration.

The FDA encourages manufacturers to use an approach that works for their specific purposes, considering how any changes might impact the biocompatibility of the device.

Content on this page comes from Attachment F in Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," also referred to as the FDA's Biocompatibility Guidance on Use of ISO 10993-1.

On this page:

Component Documentation

For each component and any joining processes/materials (for example, adhesives or sintering processes), the sponsor can provide either of the following statements:

Comparison Type Sample Statement
Comparison to test article

The [polymer/metal/ceramic/composite name] [component name] of the test article is identical to the [component name] of the medical device in its final finished form in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).

Comparison to previously marketed device The [polymer/metal/ceramic/composite name] [component name] of the medical device in its final finished form is identical to the [component name] of the [name] (device that is legally marketed in the US ) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).

Note: The FDA recommends that you include the submission number and date where the device that is legally marketed in the U.S. was given marketing authorization.
[SOURCE: FDA's Biocompatibility Guidance on Use of ISO 10993-1]

Device Documentation

If the component documentation statement is true for all of the device component material formulations, processes, and sterilization methods (if applicable) in the device, the sponsor can provide either of the following general statements:

Comparison Type Sample Statement
Comparison to test article

The test article is identical to the medical device in its final finished form in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).

Comparison to previously marketed device The medical device in its final finished form is identical to [name] (previously marketed device) in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).

New Processing/Sterilization Changes

"If there are any processing or sterilization changes that the sponsor believes will not alter the biocompatibility of the medical device in its final finished form, the sponsor should use the component documentation language and include either of the following qualifiers:"

Comparison Type Sample Statement
Comparison to test article

...with the exception of [identify change]. FDA submission exhibit [#], page [#], submitted on [date], provides scientific information to demonstrate that the [processing/sterilization] change does not alter the chemical or physical properties of the medical device in its final finished form, and therefore, results from the test article can be applied to the medical device in its final finished form.

Comparison to previously marketed device ...with the exception of [identify change]. FDA submission exhibit [#], page [#], submitted on [date], provides scientific information to demonstrate that the [processing/sterilization] change does not alter the chemical or physical properties of the medical device in its final finished form, and therefore, results from the [name] (device that is legally marketed in the U.S. ) can be applied to the medical device in its final finished form.

Notes:

  • Details to support claim: "The information provided to support a claim that processing and sterilization changes will not affect chemical or physical properties of the medical device in its final finished form should be provided in sufficient detail for the FDA to make an independent assessment during our review and arrive at the same conclusion."
  • Raw materials: "Changes in raw material suppliers or raw material specifications could introduce different types or quantities of residual chemicals and could result in a toxic response (even if the base material has a long history of safe use in similar applications)."
    • "In some cases, chemical characterization at the raw material level may be sufficient to show comparability and to justify not conducting device level testing. However, some resin changes may result in changes to physical properties and/or surface characteristics of the medical device in its final finished form that could affect the biological response." [SOURCE: FDA's Biocompatibility Guidance on Use of ISO 10993-1]
  • Surface alterations: "The impact of surface alterations due to processing, even at the micron or submicron level, should be evaluated when there is a reasonable possibility that they could result in geometrical or chemical changes at the surface which, in turn, could result in an adverse biological response (even if the base material has a long history of safe use in similar applications)."

Formulation Changes

"If there are any formulation changes the sponsor believes will not alter the biocompatibility of the medical device in its final finished form, the sponsor should use the component documentation language and include the following qualifier:"

Comparison Type Sample Statement
Comparison to test article

...with the exception of [identify change]. FDA submission exhibit [#], page [#], submitted on [date], provides scientific information to demonstrate that the formulation change does not alter the chemical or physical properties of the medical device in its final finished form, and therefore, results from the test article can be applied to the proposed medical device in its final finished form.

Comparison to previously marketed device ...with the exception of [identify change]. FDA submission exhibit [#], page [#], submitted on [date], provides scientific information to demonstrate that the formulation change does not alter the chemical or physical properties of the medical device in its final finished form, and therefore, results from the [name] (device that is legally marketed in the U.S. ) can be applied to the medical device in its final finished form.

Example: If your comparator device that is legally marketed in the U.S. contains a PEBAX® resin, and your subject device contains a different grade of PEBAX®, your documentation should include a qualifier that states that the untested PEBAX® grade varies only in the concentration of specific formulation components. Formulation changes that introduce novel components, or a higher concentration of an existing component, may warrant a new risk assessment or new testing if the upper and lower bounds of each component have not been previously evaluated.

Note: "The information provided to support a claim that formulation changes will not affect chemical or physical properties of the medical device in its final finished form should be provided in sufficient detail for FDA to make an independent assessment during our review and arrive at the same conclusion." To support this assessment, the FDA requests that the sponsor provide all of the following:

  • "Formulation of the test article and possible impurities or leachable chemicals."
  • "Formulation of the medical device in its final finished form and possible impurities or leachable chemicals."
  • "A discussion of why the differences would not necessitate additional testing."
 
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