By Michael Nevin Helmus
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Additional resources for Biomaterials in Design and Reliability of Medical Devices (Tissue Engineering Intelligence Unit)
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 Muscle and Bone; F622 Preformed Cranioplasty Plates that Can be Altered Silicone elastomer; Polyurethane; Silicone gel; Texture surfaces; Permeation barrier to silicone gel nonsilicone gel Hydrogels; Saline filled Tissue inflammation; fibrous capsule contracture; Rupture of shell; Tissue adhesion; Migration of device; Tissue erosion; Matching compliance of surrounding soft tissue; Leakage of gel Draft Guidance Preparation of FDA Submissions of Silicone Gel-Filled Breast Prostheses, Oct.
A. Ulatowski, “Device Sterility Guidances and Validation. Medical Device and Diagnostic Industry, June 1998:58. 13 Detailed description of sterilization methodologies and medical device infections can be found in "Disinfection, Sterilization, and Preservation" Seymour Block, ed. Lippincott, Williams & Wilkins, 2000.
If the material is being supplied to the device manufacturer’s specification, a 510(k) is probably not necessary. For example, a device manufacturer might include a transparency requirement in the purchase specification for tubing to be used in an implantable catheter. Such a requirement might be related to the later processing of the tubing into the finished device. To change the supplier of that material without the need for a new 510(k), the specification should include a transparency requirement, and the device manufacturer’s design validation, as required by the GMP regulation, must describe the rationale for that transparency requirement.
Biomaterials in Design and Reliability of Medical Devices (Tissue Engineering Intelligence Unit) by Michael Nevin Helmus