To all Biomeds and friends of Biomeds Patrick K. Lynch CBET, CCE, CHTM Note: The first few pages of this are introductory materials. But I and the biomed profession need you to write a very important email the AHA about our future. If you do not have time to read this, go to the… Continue reading Take This Step to Save The HTM Profession!
Posted on January 29, 2017 by Jerri-Lynn Scofield at Naked Capitalism By Jerri-Lynn Scofield, who has worked as a securities lawyer and a derivatives trader. She now spends most of her time in Asia researching a book about textile artisans. She also writes regularly about legal, political economy, and regulatory topics for various consulting clients and… Continue reading Waste Not, Want Not: Right to Repair Laws on Agenda in Some States
Readers: During the FDA Workshop in October, during which they heard statements regarding their decision to regulate or not regulate third-party servicers and remanufacturers of medical devices, the Federal Trade Commission was represented by one of their staff Attornies. She cited this Executive Order and cautioned the FDA not to make decisions which would violate… Continue reading FDA Hearing on Servicers – The President’s Opinion
A public opinion survey commissioned by the Medical Imaging & Technology Alliance (MITA)finds the majority of Americans believe proper servicing and maintenance of all medical and radiation-emitting electronic devices is crucial to protecting patients, and that all medical device servicers should be consistently regulated by the U.S. Food and Drug Administration (FDA) regardless of whether they… Continue reading Survey Reveals that Majority of Americans Favor FDA Regulation
To: OCMedicalDeviceCo@fda.hhs.gov From: firstname.lastname@example.org Subject: Allegations of Regulatory Misconduct Website and 12CFR I commend the FDA in the launch of this website and new program and form. There should be a simple way to report alleged problems. But how is the FDA going to take action on reported problems? There are already many rules and… Continue reading Email to FDA regarding AIAT Lack of Enforcement
Posted March 22, 2016 on the MedWrench Blog http://www.medwrench.com/?blogs.entry/blogEntryNo/45641/ In today’s edition of the MedWrench blog I want to touch on the recent FDA Docket requesting information and comments on the medical device industry and healthcare community that “refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices including radiation-emitting devices subject to the… Continue reading What Is The FDA Docket Really Looking For?
Thursday, March 31, 2016, 2:00pm ET Presented by an Industry Expert Panel Sponsored by MD Publishing The FDA announced a brand new docket and a “comment period” regarding refurbishing, reconditioning and remanufacturing medical devices. Anyone responsible for servicing, repairing and selling these medical devices/parts needs to be aware of this very important announcement.… Continue reading Special FDA Webinar for Medical Equipment Sales and Service Industry