Preclinical Development

Sterilization and Packing

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

Guidance for Industry and FDA: Submission and Review of Sterility Information in Premarket Notification [510(k)] Submissions for Devices Labeled as Sterile.

 

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 

 

Biocompatibility

Biocompatibility is generally tested under the International Standard ISO 10993-1. The FDA recommends, via a guidance document, how best to use the ISO 10993-1 standard to test the biocompatibility of your device.

 

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: Product Development Under the Animal Rule