PRECLINICAL DEVELOPMENT OF DEVICES
Sterilization and packing (21 CFR 820.130)
FDA regulates sterilization packaging medical devices intended for use in health care facilities.
(need article)
Mechanical testing
Mechanical testing is a critical step in turning innovative concepts into reliable medical devices. For certain types of medical devices, the FDA recommends that you include mechanical testing or provide a rationale for not conducting mechanical testing. The following are requirements with regard to mechanical testing for several types of medical devices:
Intervertebral Body Fusion Device
Ceramic Ball Hip Systems
Non-Articulating, 'Mechanically Locked', Modular Implant Components
Spinal System - THESE ARTICLES ARE ALL QUITE OLD
Biocompatibility
Guidance related to biocompatibility for medical devices
Labeling (21 CFR 801, 21 CFR 820.130)
Labeling includes labels on the device as well as descriptive and informational literature that accompanies the device. Quality System Regulation Labeling requirements and detailed guidance for labeling can be accessed on the FDA web.
Validation
Process validation guidance
Animal Efficacy
Guidance for Industry: Animal Models — Essential Elements to Address Efficacy Under the Animal Rule
Next Page - Quality System Regulation for Devices