Preclinical Development

Sterilization and Packing

(21 CFR 820.130)
FDA regulates sterilization packaging medical devices intended for use in health care facilities.

Draft Guidance for Industry and FDA: Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities

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 


Guidance related to biocompatibility for medical devices


(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.


Process validation guidance

Animal Efficacy

Guidance for Industry: Animal Models — Essential Elements to Address Efficacy Under the Animal Rule