Tag: FDA

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Continuous Compliance for Connected Medical Devices: Reducing the Time From Change to Response

How to update cybersecurity assessments and controls between scheduled reviews.

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FDA to Exempt Several Unclassified Medical Devices from Premarket Notification

New guidance identifies low-risk devices in eight medical specialties that will no longer require 510(k) submissions to reduce regulatory burdens.

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US and UK Regulators Strengthen Cooperation on Medical Device Approvals

The partnership between the Food and Drug Administration and the Medicines and Healthcare products Regulatory Agency aims to streamline technology access and reduce regulatory duplication.

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Continuous Compliance for Connected Medical Devices: Reducing the Time From Change to Response

How to update cybersecurity assessments and controls between scheduled reviews.

FDA Updates Medical Device Cybersecurity Guidance to Address New Federal Requirements

Feb 6, 2026

Revised guidance aligns with quality management system regulation changes and provides recommendations for cyber device submissions under section 524B of the FD&C Act.

GAO Report Finds FDA Struggles to Meet Medical Device Recall Termination Goals

Jan 21, 2026

The agency exceeded its three-month termination timeline for 74% of recalls during fiscal years 2020-2024, due to staff constraints that limited oversight activities, the report finds.

AHA Urges FDA to Adopt Risk-Based Oversight for AI-Enabled Medical Devices

Dec 22, 2025

The hospital association urges the FDA to adopt risk-based post-market oversight for AI-enabled medical devices while aligning new requirements with existing regulatory frameworks.

FDA to Accept De-identified Data for Certain Medical Devices Submissions

Dec 19, 2025

New guidance permits the use of de-identified data without requiring individual patient information in marketing submissions.

FDA Launches Digital Health Pilot for Chronic Disease Technologies

Dec 8, 2025

The pilot will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use in chronic conditions.

Medcrypt Launches Platform to Support Cybersecurity Compliance for Device Manufacturers

Nov 17, 2025

The software is intended to help manufacturers demonstrate cybersecurity maturity as expectations from regulators and hospital purchasers continue to rise.

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FDA Seeks Public Comment on Real-World AI Medical Device Performance

The agency is requesting public comment on methods for monitoring and evaluating AI models after deployment to ensure continued safety and effectiveness.