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Title Page, Document Number.

Document control number changed, so as not to be confused with the discontinued guidance document GD016. Document is no longer draft.

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Entire Document

Minor editorial and style changes.

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4.1.2 Chemical Analysis

Cryogrinding is not recommended for sample preparation.

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5.1 Preclinical Testing

Clarification regarding the testing of the thinnest possible samples, alternate methods may be required.
Applicability of joint testing with domed or button valves discussed.
Fold Flaw testing no longer required.
Abrasion testing no longer required.
Fatigue rupture testing to include stress calculations, and a recommendation to use load controlled apparatus.

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5.2 Clinical Testing

Consideration given to further subdividing reconstruction patients into reconstruction and augmentation sub-groups. To take into account the previous overall health history of the patient.
Breast cancer patients are excluded from the long term reconstruction study population.

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5.2.2 Safety Assessment

Discussion around MRI follow studies has been expanded. Basic definitions provided.
Prospective collection and preservation of serum (or plasma) samples is not required. Collection and testing of serological samples as recommended during scheduled follow-up visits is still required.