Our medical device clients often ask us for assistance in understanding the ins and outs of in-vitro diagnostics. We’ve put together a multi-part primer on IVD studies that is designed to cover what medical device manufacturers need to know about this sector of the industry. At their core, IVD studies are not significantly different from … continue reading
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Venture Capitalists Pressure FDA About Medical Device Approval Process
It’s a refrain that is becoming familiar in the medical device industry: over-regulation is strangling innovation. Recently, however, this particular topic isn’t being championed by special interest groups representing medical device companies, but rather by a growing number of concerned outsiders from the venture capital industry who are becoming increasingly convinced that FDA regulations are … continue reading
Pulse of the Industry Report Offers Insight For Medical Device Manufacturers
The Ernst & Young “Pulse of the Industry: Medical Technology Report 2011” was released last month, bringing with it a host of data, recommendations, and insight applicable to medical device manufacturers of all sizes. The report, which was presented at the Advamed 2011 conference, aims to offer a global analysis of the entire medical device … continue reading
Smaller Medical Device Companies Facing Extended 510(k) Review Periods
Smaller medical device companies aren’t imagining things – it really does take longer to receive 510(k) approval for medical device developers with fewer than 100 employees than it does for larger industry players. This startling information comes from a study published this summer by researchers at Northwestern University, which took a hard look at how … continue reading
AdvaMed Releases Competitiveness Agenda to Preserve Medical Device Innovation
Medical device companies have become increasingly concerned with the potential for new FDA regulations to negatively impact their ability to remain competitive in the global market. Earlier this summer, the Advanced Medical Technology Association (AdvaMed) put together a series of recommendations on how to shape regulatory policy in order to deal with this particular problem … continue reading
FDA Update: Administration Announces Initiative to Improve Reusable Medical Device Reprocessing and Conducts Two Day Workshop
Health care providers routinely reuse medical devices for the diagnosis and treatment of multiple patients. The process for preparing a reusable medical device for use on or by a patient is referred to as “reprocessing.” It is critical that the processes, procedures, and materials used for reprocessing be adequate to ensure that the reprocessed device … continue reading
FDA Proposes Draft Guidance for Regulating Mobile Medical Device Apps
The FDA has proposed guidelines designed to regulate what it considers to be particularly risky mobile medical device apps. After struggling with piecemeal medical device app regulations over the past year, and in the face of recommendations from industry groups, the FDA has elected to focus on a specific category of apps that could directly … continue reading
MDCI’s Rosina Robinson to Present Webinar Entitled “New Updates on the 510(k): The IOM Report”
MDCI’s own Rosina Robinson, RN, M.Ed., RAC, and Principal Consultant, will be presenting a webinar tomorrow through Thompson Interactive entitled “New Updates on the 510(k): The IOM Report.” This webinar touches on the subject of yesterday’s MDCI blog post discussing the IOM report’s recommendations that the current 510(k) process be scrapped in favor of an … continue reading
