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So far MDCI has created 19 blog entries.

A Closer Look At The FDA’s Human Factors Engineering Draft Guidance

In an effort to control overall risk in medical devices, the FDA has looked to Human Factors Engineering (HFE) as part of the design controls process to reduce or eliminate use-related hazards. Central to that process is the development of a risk analysis, which takes into account potential hazards that can occur through the use of a medical device. [...]

By |2016-07-12T16:04:42-05:00January 12th, 2012|510(k), cGMP Quality Assurance and FDA 483s, Medical Devices|

VCs 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 beginning to choke back the [...]

New E&Y Report Offers Insight Into Med Device Approval Processes

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 2011conference, aims to offer a global analysis of the entire medical device industry from a regulatory, economic, and demographic [...]

By |2016-07-12T16:09:10-05:00November 15th, 2011|510(k), cGMP Quality Assurance and FDA 483s, Medical Devices|

FDA Makes Changes To Informed Consent Requirements for Medical Device Trials

This past spring, medical device companies – and all other organizations participating in clinical trials – became subject to a new Final Rule regarding informed consent.  Specifically, the FDA implemented changes to existing informed consent regulations that now require the submission of clinical trial descriptions to the public databank.  Trial participants must be informed of this fact by way [...]

By |2016-07-12T16:02:33-05:00October 18th, 2011|510(k), cGMP Quality Assurance and FDA 483s, Medical Devices|

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 much time companies of various [...]

By |2016-07-12T15:52:58-05:00October 13th, 2011|510(k), cGMP Quality Assurance and FDA 483s, Medical Devices|

FDA Loosens Premarket Notification Requirements for 30 Medical Device Types

Medical device companies operating in the in vitro diagnostic and radiology sectors of the industry received some surprising news this past month when it was revealed that the FDA had decided to relax certain regulatory requirements pertaining to these products.  Specifically, a number of device types will now be exempt from premarket notification requirements. […]

CDRH’s Shuren Warns Medical Device Manufacturers About Rough Road Ahead

Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health (CDRH) recently had some alarming words of warning for medical device manufacturers operating in the United States.  According to Dr. Shuren, a number of different factors have come together to place unprecedented pressure and strain on the medical device industry, with no clear indicators as to when the situation [...]

Top 5 Info Sources for Medical Device Manufacturers

The Internet offers a seemingly unlimited information resource for medical device developers, allowing them to tap into regulatory information and guidance, market reports and consumer opinion, as well as in-depth coverage of the state of the industry as a whole. Unfortunately, the broad reach of the online world also means that not all news sources carry the same weight when [...]

By |2016-07-12T16:08:47-05:00June 9th, 2011|510(k), cGMP Quality Assurance and FDA 483s, FDA, Medical Devices|