FDA

Posts tagged with “FDA”

Helen Simons

4 Regulatory Trends to Watch In 2024

FDA Quality Management System Regulation (QMSR) In February 2022, FDA released proposals for aligning their Quality System Regulation (QSR) with the commonly used ISO 13485 Medical devices – Quality management systems[1] – Requirements for regulatory purposes. This had been long awaited and was rumoured to be coming for many years prior to this point. As […]

Alexandra Reid

5 Key Points in FDA’s Real-World Evidence Draft Guidance

The FDA is making significant strides in integrating real-world data (RWD) into the regulatory framework for medical devices. A recent 40 page draft guidance, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” issued by the FDA elaborates on how real-world evidence (RWE) can be effectively used in regulatory decision-making for medical devices.

Taimoor Khan

FDA Draft guidance: Marketing Submission PCCP Recommendations for AI/ML-Enabled Device Software Functions

The FDA recently (April, 2023) came out with a draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions. The document provides guidance for developing a Predetermined Change Control Plan (PCCP) for managing changes to the device software functions. The PCCP is a critical component of […]

Christian Fleischhacker

Medhealth Review: Five Tips to the FDA eSTAR Application Submission Process

The March 27, 2023 edition of Medhealth Review features Five Tips to the FDA eSTAR Application Submission Process by Alexandra (Sandy) Reid, QA/RA Specialist at StarFish Medical. Starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted electronically using eSTAR. Reid offers five tips to keep in mind when using the application for the […]

Alexandra Reid

FDA and Health Canada streamline medical device submissions with joint eSTAR portal

The U.S. Food and Drug Administration (FDA) is partnering with Health Canada to launch a joint electronic Submission Template and Resource (eSTAR) pilot. The joint pilot, announced on January 10th, 2023, will test the feasibility of allowing sponsors to submit medical device submissions to both regulatory bodies through the FDA’s eSTAR online portal. Requests for […]

Join over 6000 medical device professionals who receive our engineering, regulatory and commercialization insights and tips every month.

Website Survey

Please answer a few questions about our website.

Take Survey No Thanks