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Contaminants : The presence of proteases, bacteria, or other contaminants can lead to peptide breakdown

For a complete list of codes and FDA categories, please see file titled Skin Substitute Products by FDA Regulatory Category available on the CMS website under downloads for the CY 2026 PFS final rule at

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Rigorous Analytical Verification: Every batch undergoes High-Performance Liquid Chromatography (HPLC) and Mass Spectrometry (MS) to confirm that the chemical signatures match the intended profiles without synthesis by products