AG/FDA Blog

OFW Law Launches FDA DevicEd Training Initiative

OFW Law is proud to announce the launch of its FDA DevicEd Training Initiative. The initiative is devoted to providing high quality FDA regulatory training to foreign and domestic medical device companies and the advisors who assist them. Interactive… Read More
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FDA Decides Not to Actively Regulate Medical Device Data Systems, Medical Image Storage Devices, Medical Image Communication Devices and Similar Mobile Medical Apps

There is good news for certain sectors of the medical device industry. FDA has decided not to actively regulate medical device data systems (MDDS), medical image storage devices, medical image communication devices and similar mobile medical applicat… Read More
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Phil Olsson and Rick Frank on 35 Years of Life at OFW

Phil: Rick, it’s hard to believe that 35 years have passed since we started this firm as a two-lawyer shop in 1979. Rick: It sure is. I remember working with you at the law firm I joined fresh out of the University of Michigan Law School, and which… Read More
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How to Legally Import and Market Medical Devices in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP October 1, 2014, 1:00 p.m. EST During this webinar, the first of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfull… Read More
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How to Legally Import and Market Medical Devices in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP October 1, 2014, 1:00 p.m. EST During this webinar, the first of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfull… Read More
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FDA/ONC/FCC Health IT Report Signals Possible Deregulation of Certain Software Medical Devices

Has the U.S. Food and Drug Administration (FDA) opened the door to deregulation of certain software medical devices? Its recently issued Health IT Report seems to indicate so, and FDA is seeking comments on the report. Now is the time to weigh in on… Read More
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FDA/CDRH Revamps Structure of its Office of Compliance

This past Monday (November 18), the FDA Center for Devices and Radiological Health (CDRH) launched a new webpage describing the revamped structure of its Office of Compliance (OC). One of the stated goals of the reorganization is to better align OC&#… Read More
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MDR Reporting of Foreign Adverse Events -- What is Your Obligation?

Under the U.S. Food and Drug Administration’s (FDA) Medical Device Reporting (MDR) Regulation, 21 C.F.R. Part 803, medical device manufacturers must report adverse events involving their devices to FDA when information reasonably suggests that: The… Read More
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What's Important in Assessing the Need for Additional 510(k) Clearance for Medical Device Changes?

Medical device companies often find themselves in a bind if the U.S. Food and Drug Administration (FDA) scrutinizes their decisions that product changes did not trigger the regulatory requirement for a new 510(k) submission for the changed device. Th… Read More
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