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What approvals do I need?

This depends on many things, but the following questions should always be addressed:

  • Does the target market demand specific approvals?
  • Does your insurance company demand specific approvals?
  • Does it need to be implantable for more than 29 days?
  • Does it need to be resistant to certain chemicals?
  • Must it be able to withstand sterilisation methods (e.g. autoclaving)?
  • Should it be resistant to weather/ozone/UV?
  • What physical characteristics are required?
  • Does it need to be pigmented (i.e. will it be coloured or transparent?
  • Are there cost constraints? What is the proposed manufacturing technique?
  • We always recommend that you look at the original source of these approvals when assessing suitable materials for your own product.

The following references may also be helpful:

  • FDA Food Grade (21 CFR 177.2600) see the FDA website