The medical device industry has enjoyed tremendous growth in both revenues and the technical complexity of the products that it produces over the past 10-20 years. Along with that growth, serious adverse event reports related to medical device use have increased as well.
The FDA recently issued a report in effort to assess and understand gaps in medical device quality. Its purpose is to provide a perspective on the state of medical device quality, as well as the challenges and opportunities for improvement.
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5 Tips on Steering Medical Devices Through the FDA
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Millions of people use a 510(k) cleared medical device daily without even realizing the product has been evaluated by the Food and Drug Administration...It's the toothbrush.
Medical devices fall within a broad range and it's important for companies to understand their devices and the products they are equivalent to in order to successfully navigate the regulatory process.
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FDA Points to Increased Drug Approvals
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Making a case for the nation's current drug approval system, federal officials have announced that a relatively high 35 new medicines were cleared by regulators in the recently completed federal fiscal year.
The Food and Drug Administration said in a news release that only one other year in the past decade has yielded more drug approvals.The agency's commissioner, Dr. Margaret Hamburg, called it "a very strong performance, both by industry and by the FDA."
Read complete article.
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FDA Seeking Comment on Device Recall Data Collection Policy
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The US Food and Drug Administration is requesting comment on its information collection practices regarding medical device recall policies.
The FDA's device recall process, authorized by US federal law, consists of three steps.
Read complete article. |
The State of Medtech 2011 and Beyond: A SWOT Analysis
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An interesting look at the medtech industry for 2011 and beyond, objectively identifying the key strengths, weaknesses, opportunities, and threats it faces.
Read complete article. |
Pharma Purchasing and Outsourcing Approach Needs Overhauling, Supply Chain Expert Asserts
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Regulatory pressure and "true cost" understanding will push pharmaceutical firms to reverse the current outsourcing trend and gain back more control of their critical ingredients and components, supply chain expert Andrew Cox asserts.
Supply chains in the pharma industry are "very different" from other industries and have "unique problems," he stressed. These problems are compounded by a lack of realism around outsourcing, reflecting the manner in which purchasing decisions are made and who is involved in those decisions.
Read complete article. |
GHTF Issues Device Classification Guidance
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As it transforms into a new organization, the Global Harmonization Task Force (GHTF) continues to issue guidances likely to influence major medical device regulators worldwide.
Last month, the GHTF's Study Group 1 published guidance on medical device classification principles.
Read complete article. |
Poll : What organizational role selects the resulting Corrective Action / Preventive Action?
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Most electronic CAPA systems allow for a CAPA request, resulting from an investigation, to be assigned to an individual or group. Who in your organization determines what the resulting Corrective Action and/or Preventive Action will be?
Take the poll. |
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Monthly Newsletter
PathWise, Inc.
November 2011 |
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Upcoming Events
CAPA for Life Sciences
These 2-day courses are designed to meet the requirements mandated by regulatory agencies to effectively investigate and locate causes and correct them.
Feb. 15-16, 2012
Switzerland
_________________ Audit Management
This 2-day course is designed to to train and prepare individuals to manage the quality audit process through reading, lecture, discussion, role playing, and practical exercises.
March 15-16, 2012
Chicago, IL
June 14-15, 2012
Boston, MA
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PathWise Webinars
Integrating FDA and Trending
Requirements into your CAPA System
This session offers attendees a how-to approach to effectively integrate the FDAs CAPA and trending requirements, providing them with the skills and tools necessary to develop a strong, sustainable and compliant CAPA System.
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Best Practices to Manage an FDA Inspection
When it comes to quality system audits, the level of preparation within your organization can make a significant difference in your level of success. This webinar discusses how to effectively prepare for and manage an FDA inspection.
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Conducting OOS and Non-Conformance Investigations
Attendees will learn how to effectively expedite and document OOS and non-conformance investigations to increase compliance in their organizations.
Download webinars.
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