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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

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

FDA Draft Guidance for Computer Software Assurance a Fresh Look at Risk

ICH Expands on Analytical Methods Validation in Draft- Q2 Update

FDA Releases ICH Draft Guidance for Drug Analytical Procedure Development

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

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

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

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 De Novo Device Program a Tremendous Value

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

De Novo Final Rule Retains Pre-Decision Inspections

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

The Risks and Benefits of FDA’s Special Controls

Clarity of Intended Use a Key Point in IVDR Device Classification

MDSAP Nonconformity Grading System a Significant Update

Moderate-Risk Designations Dominate FDA List of AI Devices

The Risks of Different Risk Classification Systems

Circuit Court Sides with Rotenberg Against FDA

New VALID Act Phase-in May be as Short as Three Years

WHO Enters AI Debate with Report on Guiding Principles

FDA Cites Record-keeping, Inspections in Remanufacturing Draft

FDA Developing Cybersecurity Policy for Serviced Devices

EU Draft Legislation for AI May Add Regulatory Hurdles

FDA Tightens Turn-Around Times for Section 522 Studies

FDA Reins in Timelines for Post-Approval Studies

Fate of MCIT Uncertain, But Cures 2.0 a Possible Solution

ML Algorithm for COVID-19 Incurs Large Premarket, Postmarket Studies

FDA Calls for Evaluation of Tests for SARS Variants

FDA, ISO and the Risk Management Quandary

FDA Electromagnetic Compatibility Requirements Growing

IMDRF’s Five-Year Plan Includes Single Review

FDA STeP Program Offers Expedited Review

Remote Audits are Gaining Traction in the Era of COVID-19

FDA Action Plan for AI an Incremental Step

FDA Cybersecurity Communications Likely to be Costly

FDA Posts Microneedling Final Guidance

CDRH Wraps Up Guidance for Nitinol Devices

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

FDA: Work Continues on PreCert Pilot

Breakthrough Devices May Draw Four Years of Medicare Coverage

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

HHS: Rulemaking Required for FDA Regulation of LDTs

FDA and Software Assurance: A Solution to the Validation Impasse

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

Innovation in SaMD Regulation: Video Games as Medical Devices

FDA, IMDRF Chart Different Courses on Cybersecurity

Combination Products Still a Challenge for FDA

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

Leftovers: Top Five Unfinished FDA Draft Guidances from 2019

ISO 13485 and Part 820: Delays and Opportunities

Best Practices for Handling Customer Complaints Post-Market

Enzyme Offers Support for Teams Dealing with COVID-19

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

What Digital Health companies can expect from the FDA in 2020

Expert Interview: Clinical Trial Planning for Startups with Boulder Clinical Science

2019 RAPS Regulatory Convergence #2019RAPS

Farewell, Dr. Gottlieb, you will be missed

Creating A Culture Of Quality

Our top conference picks for SaMD companies

FDA Pre-Cert v1.0 Explained: 2019 and the Promises of Years to Come

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