Staying Healthy: What You Need to Know About FDA Reporting For Safer Medical Products
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Greg Garner
May 11, 2013, 12:12:04 AM5/11/13
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Please consider this free-reprint article written by:
Greg Garner
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Article Title: Staying Healthy: What You Need to Know About FDA Reporting For Safer Medical Products
Author: Greg Garner
Word Count: 518
Article URL: http://www.isnare.com/?aid=1837971&ca=Wellness%2C+Fitness+and+Diet
Format: 64cpl
Contact The Author: http://www.isnare.com/eta.php?aid=1837971
Easy Publish Tool: http://www.isnare.com/html.php?aid=1837971
*********************** ARTICLE START ***********************
Since 1984, the Food and Drug Administration (FDA) requires any medical firm or individual health care practitioner that has received notice or complaints of malfunctioning devices, injuries, or deaths associated with medical devices or products, to report the incident back to the FDA. Any medical organization operating within the USA is required to comply with the standards imposed by the FDA and to ensure that their reporting mechanisms are up to date. Read below to find out everything you need to know about FDA reporting for safer medical products.
Purpose of the Regulation
The FDA introduced the reporting regulation as a means to provide the Administration with sufficient information regarding how medical devices and products work once released on the market. Health care professionals are required to make their reports to the manufacturer and, in case this information is unknown, directly to the FDA.
The main purpose behind the FDA reporting for safer medical products is to get a clearer idea on how devices function in the real world, as well as to immediately correct any issues that may arise during the use of a particular medical device or product.
Main Outcomes
Since its implementation, the FDA regulation has managed several things. For one, it has given the Administration more regulatory power. The FDA is now able to suspend, at least temporarily, the release of certain devices which are thought to be potentially harmful to human life or health. Additionally, the FDA is also able to mandate manufacturers to recall any of their products that have not functioned properly. Fines have introduced as a means to discourage noncompliant behavior on behalf of medical device manufacturers.
But the FDA reporting for safer medical products has also had a positive impact on the medical system and society in general. The reports submitted by health care professionals nationwide have lead to a decrease involving injuries or deaths caused by malfunctioning devices and have increased the safety of medical products that are currently allowed on the market. This has lead to not only a more efficient and secure medical system, but to a greater level of trust on behalf of patients and the general public.
Reporting Mechanism
Any health care professional that comes in contact with a malfunctioning medical device or product is required to make a complaint. Efficient reporting can be achieved several ways. The easiest option involves logging on to the FDA�s official website and filling out an application called Reporting Form 3500. The FDA also offers submission guidelines which practitioners have to take into account when submitting reports. Other options involve reporting the incidents over the telephone, via mail, or by fax machine.
These are some of the most important things you need to know about the FDA regulation and medical device reporting. Overall, the FDA reporting for safer medical devices initiative has had numerous positive outcomes. The more health care professionals realize the importance of reporting and of complying with FDA regulations, the safer and more efficient will the medical system work.
About The Author: For more information, please visit our FDA Reporting for Safer Medical Products website http://www.hipaaexams.com/fda-reporting-for-safer-medical-products.asp
Please use the HTML version of this article at:
http://www.isnare.com/html.php?aid=1837971
*********************** ARTICLE END ***********************
- To distribute your articles go to http://www.isnare.com/distribution.php
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Message delivered directly to members of the group:
publish-the...@googlegroups.com
*****************************************************************
Please consider this free-reprint article written by:
Greg Garner
*****************************
IMPORTANT - Publication/Reprint Terms
- You have permission to publish this article electronically in free-only publications such as a website or an ezine as long as the bylines are included.
- You are not allowed to use this article for commercial purposes. The article should only be reprinted in a publicly accessible website and not in a members-only commercial site.
- You are not allowed to post/reprint this article in any sites/publications that contains or supports hate, violence, porn and warez or any indecent and illegal sites/publications.
- You are not allowed to use this article in UCE (Unsolicited Commercial Email) or SPAM. This article MUST be distributed in an opt-in email list only.
- If you distribute this article in an ezine or newsletter, we ask that you send a copy of the newsletter or ezine that contains the article to http://www.isnare.com/eta.php?aid=1837971
- If you post this article in a website/forum/blog, ALL links MUST be set to hyperlinks and we ask that you send a copy of the URL where the article is posted to http://www.isnare.com/eta.php?aid=1837971
- We request that you ask permission from the author if you want to publish this article in print.
The role of iSnare.com is only to distribute this article as part of its Article Distribution feature ( http://www.isnare.com/distribution.php ). iSnare.com does NOT own this article, please respect the author's copyright and this publication/reprint terms. If you do not agree to any of these terms, please do not reprint or publish this article.
*****************************
Article Title: Staying Healthy: What You Need to Know About FDA Reporting For Safer Medical Products
Author: Greg Garner
Word Count: 518
Article URL: http://www.isnare.com/?aid=1837971&ca=Wellness%2C+Fitness+and+Diet
Format: 64cpl
Contact The Author: http://www.isnare.com/eta.php?aid=1837971
Easy Publish Tool: http://www.isnare.com/html.php?aid=1837971
*********************** ARTICLE START ***********************
Since 1984, the Food and Drug Administration (FDA) requires any medical firm or individual health care practitioner that has received notice or complaints of malfunctioning devices, injuries, or deaths associated with medical devices or products, to report the incident back to the FDA. Any medical organization operating within the USA is required to comply with the standards imposed by the FDA and to ensure that their reporting mechanisms are up to date. Read below to find out everything you need to know about FDA reporting for safer medical products.
Purpose of the Regulation
The FDA introduced the reporting regulation as a means to provide the Administration with sufficient information regarding how medical devices and products work once released on the market. Health care professionals are required to make their reports to the manufacturer and, in case this information is unknown, directly to the FDA.
The main purpose behind the FDA reporting for safer medical products is to get a clearer idea on how devices function in the real world, as well as to immediately correct any issues that may arise during the use of a particular medical device or product.
Main Outcomes
Since its implementation, the FDA regulation has managed several things. For one, it has given the Administration more regulatory power. The FDA is now able to suspend, at least temporarily, the release of certain devices which are thought to be potentially harmful to human life or health. Additionally, the FDA is also able to mandate manufacturers to recall any of their products that have not functioned properly. Fines have introduced as a means to discourage noncompliant behavior on behalf of medical device manufacturers.
But the FDA reporting for safer medical products has also had a positive impact on the medical system and society in general. The reports submitted by health care professionals nationwide have lead to a decrease involving injuries or deaths caused by malfunctioning devices and have increased the safety of medical products that are currently allowed on the market. This has lead to not only a more efficient and secure medical system, but to a greater level of trust on behalf of patients and the general public.
Reporting Mechanism
Any health care professional that comes in contact with a malfunctioning medical device or product is required to make a complaint. Efficient reporting can be achieved several ways. The easiest option involves logging on to the FDA�s official website and filling out an application called Reporting Form 3500. The FDA also offers submission guidelines which practitioners have to take into account when submitting reports. Other options involve reporting the incidents over the telephone, via mail, or by fax machine.
These are some of the most important things you need to know about the FDA regulation and medical device reporting. Overall, the FDA reporting for safer medical devices initiative has had numerous positive outcomes. The more health care professionals realize the importance of reporting and of complying with FDA regulations, the safer and more efficient will the medical system work.
About The Author: For more information, please visit our FDA Reporting for Safer Medical Products website http://www.hipaaexams.com/fda-reporting-for-safer-medical-products.asp
Please use the HTML version of this article at:
http://www.isnare.com/html.php?aid=1837971
*********************** ARTICLE END ***********************
- To distribute your articles go to http://www.isnare.com/distribution.php
- For more free-reprint articles go to http://www.isnare.com
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