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ABMSPSDO ANSI/ABMSPSDO ASN-001-2018

Inserts for Diabetic Footwear
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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.
SDO ABMSPSDO: American Board of Multiple Specialties in Podiatry Standards Developing Organization
Document Number ASN-001
Publication Date Jan. 1, 2018
Language en - English
Page Count 35
Revision Level
Supercedes
Committee
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