Author Archives: Lyn Denend
New EU Rules on Medical Devices
The European Parliament has voted to enact final legislation for Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR) that will tighten how these products are marketed in Europe. The MDR will replace the EU’s current Medical Device Directive … Continue reading
HHS proposes updated rules governing research on study participants
The US Department of Health and Human Services (HHS) announced proposed revisions to the regulations that govern research on individuals who participate in research. The current regulations, referred to as the Common Rule, have been in place since 1991 and … Continue reading
FDA releases new case study about the IDE process
The FDA announced the it has published its 8th case study entitled “The Investigational Device Exemption (IDE) Process: When is an IDE the Right Choice?” This new case explains what an IDE study is, what types of medical devices do and … Continue reading
Colombia seeks to attract medtech companies for clinical trials
The government of Colombia, in collaboration with the clinical development firm Interventional Concepts, is actively seeking to promote Colombia as a destination for early-stage clinical trials. Between 1995 and 2013, 738 clinical trials were conducted in the country. Although approximately … Continue reading
FDA releases new case study about its pre-submission program
The FDA announced the it has published a new case study that illustrates how innovators can seek feedback from the agency through its pre-submission program. The case is part of the National Medical Device Curriculum, which seeks to provide innovators … Continue reading
FDA Early Feasibility Study (EFS) guidance intended to spur US-based device innovation
When reviewing chapter 5.3 Clinical Strategy, readers may be interested in accessing the FDA’s guidance on “Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.” The agency released this guidance in … Continue reading
FDA releases new case study on the de novo pathway for medical devices
The FDA recently released a new case study entitled “De Novo Pathway for Medical Devices: Using the De Novo Process to Classify and Bring to Market an Innovative, Low-to-Moderate Risk Device.” The case is part of the National Medical Device … Continue reading
Correcting the names of two important textbook contributors
Our apologies go to Robson Capasso and Justina Kayastha for the misspellings of their names in the new edition of the Biodesign text. We will ensure that these errors are corrected before the next print run!
Professor Jacques Marescaux, President of the IRCAD Institute, provides a review of the new edition of the Biodesign textbook
“Since its first release, Biodesign has established itself as a unique foundation of expertise for medical device entrepreneurship. No other manual has been so popular and so influential, reflecting admirably the entrepreneurial values sustaining the Biodesign endeavor. Biodesign second edition, … Continue reading
FDA clarifies differences between general wellness and regulated medical devices
On January 20, 2015, the FDA issued draft guidance clarifying key distinctions between general wellness devices and those technologies that are regulated by the agency as medical devices. The guidance, entitled “General Wellness: Policy for Low Risk Devices,” provides important … Continue reading