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ANSI/ABMSPSDO ASN-001-2018
Inserts for Diabetic Footwear ABMSPSDO ASN-001-2018
ANSI/ABMSPSDO®ASN-001-2018 provides a standard for the manufacture of inserts for diabetic footwear. The standard applies to custom fabricated, off-the-shelf (OTS), and “Library” inserts and is supported by current, widely accepted medical practice. It is based on scientific research documented by relevant, peer-reviewed literature, and provider outcomes.
ANSI/ABMSPSDO®ASN-001-2018 requires the applicant organization to
• A written , documented statement of the insert’s technical specifications for which accreditation by this standard is sought,
• Written proof of Current FDA Registration and Licensure to manufacture the insert for which accreditation by this standard is sought,
• Written proof of product validation by the Centers for Medicare & Medicaid Services (CMS) of the insert for which accreditation by this standard is sought, and
• Written proof that clearly documents either an in-house or out-sourced product quality assurance program for the manufacturing process of the insert for which accreditation by this standard is sought.
American National Standards Institute [ansi]