Procedures for design validation must address risk analysis where appropriate.
Validation is an obstacle to implementing technology. A streamlined approach is necessary.
CDRH is urging the development of medical technologies and diagnostic tests that address pain, addiction and diversion.
When FDA says stop, they mean stop!
The report discusses the quality, safety and effectiveness of medical device servicing by OEMs and third parties.
All equipment must be qualified and calibrated for its intended use.
The document aims to clear up how the agency looks at device functions that aren’t subject to premarket review of safety and effectiveness.
Can your company prove its device has been manufactured in accordance with its DMR?
When applicable, the process provides novel products with a speedier route to market.
The agency wants to make sure that all patients receive information about the risks of the female contraception device prior to implantation.