By Michael Nevin Helmus

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Extra info for Biomaterials in Design and Reliability of Medical Devices (Tissue Engineering Intelligence Unit)

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3. 3. 3. 3. 3. 3. 3. 3. 3. continued Device Materials of Materials Related Construction: Predicate Design Issues Devices and Corporate Devices/ Bill of Materials Standards/ Guidelines FDA Standards/ Guidelines ASTM, ANSI Standards/ Guidelines ISO Biodegradable Polylactide Fracture Fixation Degradation rate vs. 3. 3. continued Device Materials of Materials Related Construction: Predicate Design Issues Devices and Corporate Devices/ Bill of Materials Standards/ Guidelines FDA Standards/ Guidelines ASTM, ANSI Stainless steels; Cobalt Chrome alloys; Titanium alloys; Carbon fiber reinforced Polysulfone or Polyetheretherkeytone bone fragments; Stress transfer; Stiffness; Resistance to bending and torsion; Fretting corrosion; Stress shielding, Bone resorption; Carbon fiber release and tissue irritation Device Systems; Draft Guideline for Reviewing Spinal Fixation Device Systems; Draft Guideline for Reviewing Pedicle Screw Spinal Fixation Device Systems Intended for Severe Spondylolisthesis Polysulfone Resin for Medical Applications; F1582 Spinal Implants; F1798-97 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants Dental Stainless steels; Cobalt Chrome alloys; Titanium alloys; Nickel-based alloys; Cobalt Alloys; Gold Alloys; Calcium phosphate; Hydroxyapatite and Bioglass coatings and bone fillers; Porous coatings Integration with bone and soft tissue; Matching bone modulus; Bone/softtissue/oral interface; Formation of bone vs.

The “abbreviated 510k" is available to devices that are amenable to device-specific guidance documents, special controls, or FDArecognized consensus standards. The Food and Drug Modernization Act of 1997 has committed the FDA to a process of improvement and reengineering in the Center for Devices and Radiologic Health. , by use of a Product Development Protocols (PDPs). The PDP will be an alternative to the PMA and allows Presubmission through the initial summary submission (Filing Review), the formal PDP submission (FDA Review), data gathering (Preclinical Phase and Clinical Phase) and to completion of the process (Notice of Completion) after which the device can be marketed (PDP completed).

Lippincott, Williams & Wilkins, 2000.

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