Category

Regulation

The latest posts about #Regulation

Data, Standards Emerging for AR/VR Product Development

FDA Guidance Documents are Vital in De-Risking REMS

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

IMDRF Issues Two-Part Guidance for Personalized Medical Devices

FDA Deficiency Letters Now Subject to Supervisory Review

New Opportunities in FDA Breakthrough Devices Program

FDA Final Guidance for CDS a Drastic Rewrite of Draft

Accelerated Deadlines Held Over in FDA’s Section 522 Final Guidance

ICH Expands on Analytical Methods Validation in Draft- Q2 Update

Critical Details Abound in FDA Final Rule for OTC Hearing Aids

FDA Remote Regulatory Assessments Draft Draws a Fine Regulatory Line

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

MDCG Warning Letter to Industry: No More MDR Delays

Regulatory Framework Comparison Series: The Predicate Device

IMDRF Lays Groundwork for Harmonized Machine Learning Regulation

Regulatory Framework Comparison Series: Software as a Medical Device

Regulatory Framework Comparison Series: Risk Management

Regulatory Framework Comparison Series: Post Market Devices

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

Stream of MDCG Guidances Continues in 2022

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

Digital Tech for Clinical Trials May Carry Hefty Compliance Requirements

Class I Devices Not Exempt From FDA Intended Use Rule

FDA Predicts More Requests for Additional Information for Software

MDSAP Nonconformity Grading System a Significant Update

The Risks of Different Risk Classification Systems

WHO Enters AI Debate with Report on Guiding Principles

FDA Cites Record-keeping, Inspections in Remanufacturing Draft

FDA STeP Program Offers Expedited Review

FDA Action Plan for AI an Incremental Step

FDA Posts Microneedling Final Guidance

CDRH Guidance Agenda for FY 2021 Includes CDS Final Guidance

FDA Rolls Out ASCA Pilot Program and Guidance

New FDA Intended Use Rule Provokes New Concerns

FDA Opens Digital Health Center of Excellence

IMDRF and FDA; Twin Stars in the Med Tech Regulatory Sky

HHS: Rulemaking Required for FDA Regulation of LDTs

FDA, IMDRF Chart Different Courses on Cybersecurity

FDA Not Flying Solo in Artificial Intelligence Regulation

Making MDSAP Work for You

The Single Device Audit: Great Hopes Still Unfulfilled

Management System Status for ISO 13485 Complicates FDA Adoption

Suspended Animation; U.S. LDT Regulation Behind EU

Best Practices for Handling Customer Complaints Post-Market

Enzyme Offers Support for Teams Dealing with COVID-19

A Guide to Navigating FDA Device Risk Classifications for New Products

What Digital Health companies can expect from the FDA in 2020

2019 RAPS Regulatory Convergence #2019RAPS

Farewell, Dr. Gottlieb, you will be missed

Get more of Enzyme

Explore other categories

Ready to level up? Inquire about certification.

info@enzyme.com or

Ready to do more?

info@enzyme.com or

Enzyme Community

Join the Enzyme Community to dive into educational content, exclusive resources, and more.

Enzyme Certifications

Inquire about leveling up your Enzyme experience with professional instruction.