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Life time of product for a biodegradable device

Discussion in 'Medical Devices (21 CFR Part 820)' started by Gözde Aktener, Aug 31, 2018.

  1. Gözde Aktener

    Gözde Aktener New Member

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    how can we define life time of product for a biodegradable device? I work on a technical file of a synthetic bone graft substitute. I have to define a life time of product for bone graft but I m a little bit confused about that;

    biodegredation duration of bone graft : 6-12 months
    resorption duration of bone graft: >9 (few clinical report)

    device completes its performance in 6-12 months*
     
  2. Frank93

    Frank93 New Member

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    The bone graft dental procedure takes between 45-90 minutes and is performed in your dentist's clinic. The initial recovery period lasts about two weeks. Following the bone graft procedure, the waiting time until a solid bone mass is received is between 3-6 months, in most clinical cases.
     
  3. Gözde Aktener

    Gözde Aktener New Member

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    Thank you for your response. The test is completed in 3 months, test medium was tris buffer which simulates human body conditions. The product has received CE apporaval in last year.
     
  4. Terry Spirk

    Terry Spirk New Member

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    By definition, most synthetics are biodegradable because they're fit for being separated by the activity of living things, such as microorganisms.
    Nonetheless, there's no general definition or confirmation for the promoting claim "biodegradable". The Federal Trade Commission (FTC) has given general guidelines on what kinds of products qualify as really biodegradable and has even sued organizations for unverified, misdirecting, and additionally tricky utilization of the term on product marks.
    Current FTC guidelines express that for marketers to make such a claim, a whole product or bundle ought to totally separate and re-visitation of nature inside a "sensibly brief timeframe" after standard removal. Another proposition to fix these guidelines further characterizes a "sensibly brief timeframe" to be close to one year after standard removal. The FTC likewise expresses that marketers ought not to make unfit claims of biodegradability for things bound for landfills, incinerators, or reusing offices because deterioration won't happen inside one year.
     

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