An expert takes MD+DI through the challenges, pros and cons, and strategies for a smoother European medical device approval process.

3D Systems has received 510(k) clearance from the US Food and Drug Administration (FDA) for its 3D-printed, patient-specific cranial implant system. The VSP PEEK Cranial Implant includes a complete FDA-cleared workflow comprising segmentation and 3D modeling software, 3D Systems’ EXT 220 MED 3D printer, Evonik’s VestaKeep i4 3DF polyetheretherketone (PEEK) resin, and a pre-defined production process.

FDA is cracking down on medical device cybersecurity. In response to an increase in healthcare cybersecurity threats, prevalence of connected devices, and pressure from the United States Government Accountability Office (GAO), the agency issued final guidance on medical device quality system and premarket submission requirements. In March, FDA released an update to clarify what devices must comply, as well as to give more specifics on the proposed cybersecurity plan.

To provide an overview of EU MDR, we turned to Abhishek (Abhi) Gautam, MS, EMBA, who is an executive engineer at DDL Inc., an ISO/IEC 17025 accredited full-service testing lab that provides package, product, and materials testing to the medical device and pharmaceutical industries, headquartered in Eden Prairie, Minnesota.

The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs).