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Medical Devices

The latest posts about #Medical Devices

CDS Coalition Seeks to Reverse FDA Final Guidance for CDS

A Leaner Approach to Malfunction Reporting: FDA’s VMSR Program

Human Factors Engineering a Demanding but Vital Requirement

Extension of MDR Transition Proposed by European Commission

MDCG Proposes a Potential One-Year Extension for Medical Devices

FDA Pilot SaMD Precertification Program Offers Few Insights

Medical Device Production Systems a Significant Regulatory Undertaking

IMDRF Issues Two-Part Guidance for Personalized Medical Devices

FDA Deficiency Letters Now Subject to Supervisory Review

New Opportunities in FDA Breakthrough Devices Program

Review Times Flat Under MDUFA V, and User Fees Up Across the Board

FDA Final Guidance for CDS a Drastic Rewrite of Draft

FDA Releases ICH Draft Guidance for Drug Analytical Procedure Development

FDA Remote Regulatory Assessments Draft Draws a Fine Regulatory Line

Terms and Definitions Drive Concerns Over FDA’s Quality Systems Proposal

FDA Guidance on EMC Signals a Shift in Compliance Requirements

MDCG Warning Letter to Industry: No More MDR Delays

Regulatory Framework Comparison Series: The Predicate Device

Regulatory Framework Comparison Series: Software as a Medical Device

Regulatory Framework Comparison Series: Device Cybersecurity

EU and FDA Policies in Conflict over Product Designation

FDA’s Refuse-to-Accept Guidance a Vital Piece of the Regulatory Puzzle

FDA’s Cybersecurity Premarket Draft a Significant Rewrite

FDA Guidance Offers Short Window for Appeals

Harmonization by Reference the Driver of FDA’s Rewrite of Part 820

Non-device Functions a Potential Hazard for FDA-regulated Products

The Genus Dilemma: Cross-Referencing FDA’s GMP Requirements

De Novo Final Rule Retains Pre-Decision Inspections

Class I Devices Not Exempt From FDA Intended Use Rule

FDA Predicts More Requests for Additional Information for Software

Clarity of Intended Use a Key Point in IVDR Device Classification

Moderate-Risk Designations Dominate FDA List of AI Devices

The Risks of Different Risk Classification Systems

FDA Electromagnetic Compatibility Requirements Growing

IMDRF’s Five-Year Plan Includes Single Review

FDA STeP Program Offers Expedited Review

FDA Cybersecurity Communications Likely to be Costly

CDRH Wraps Up Guidance for Nitinol Devices

New FDA Intended Use Rule Provokes New Concerns

FDA Opens Digital Health Center of Excellence

Breakthrough Devices May Draw Four Years of Medicare Coverage

SubtleMR Demonstrates How AI Can Fit into the 510(k) Program

FDA, IMDRF Chart Different Courses on Cybersecurity

Combination Products Still a Challenge for FDA

FDA Not Flying Solo in Artificial Intelligence Regulation

Management System Status for ISO 13485 Complicates FDA Adoption

ISO 13485 and Part 820: Delays and Opportunities

Best Practices for Handling Customer Complaints Post-Market

How the Medical Device Sector Can Support Innovation Methods for Developing Digital Health Products

A Guide to Navigating FDA Device Risk Classifications for New Products

Farewell, Dr. Gottlieb, you will be missed

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