That Time FDA was ‘Unusually Thorough’ on a Form 483
What medical device company was hit with a 54-page Form 483 documenting its perceived shortcomings in 2016?
Choosing the Right Medtech Product Development Consultancy
Choosing the Right Medtech Product Development Consultancy
Is EU MDR Worth the Hassle and Expense?
An expert takes MD+DI through the challenges, pros and cons, and strategies for a smoother European medical device approval process.
3D-printed PEEK-based Cranial Implants Cleared by FDA
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.
How to Navigate FDA’s Medical Device Cybersecurity Recommendations
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.
EU MDR Poses Challenges for Manufacturers
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.
FDA under fire: Pared-down LDT Final Rule leaves unanswered questions
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).
Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions
In the Quality Management System Regulation final rule issued today, the FDA is amending the title of the regulation, and establishing requirements and provisions that clarify certain expectations and concepts used in ISO 13485:2016. The revised part 820 is referred to as the Quality Management System Regulation (QMSR).
FDA Outlines its Approach to Artificial Intelligence Regulation
U.S. regulation of artificial intelligence (AI) in medical devices will involve cooperative work among multiple departments within the FDA. On March 15, the FDA released “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” which outlines how the agency’s medical product centers plan to address the efforts required to protect public health while fostering responsible innovation in AI used in medical products and their development.
Ensuring Continued Availability of In-Vitro Diagnostics in UK, EU
Early diagnosis plays a critical role in patient outcom […]
