2016 FDA Guidance Documents You Should Know | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

View the annotated list:  2016 FDA Guidance Documents You Should Know | MDDI Medical Device and Diagnostic Industry News Products and Suppliers:

"This year FDA again issued several guidance documents that have substantial, positive implications for portfolio productivity and strategy. The following 2016 guidance documents merit careful consideration by every device manufacturer." . . .

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What the 21st Century Cures Act is, and who benefits from it - Business Insider

Read the full article: What the 21st Century Cures Act is, and who benefits from it - Business Insider:

"Sponsors of the 21st Century Cures Act call it a win-win: a fusion of funds for medical research with new rules that direct the Food and Drug Administration to approve drugs and devices with greater urgency. There's also money to help states fight the opioid epidemic, and a boost for mental health care."

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Medical Devices - A murky 510(k) world?!

"Critics say the F.D.A.’s process for reviewing medical technology, under which medical devices have become a $75 billion-a-year industry in this country, is often too lax," reports this New York Times news article, "Quickly Vetted, Treatment Is Offered to Patients." In general, the 510(k) process is intended to be a quick-review process that promotes innovation, and that most new devices improve upon an existing device so there is rarely is a need for full review.

Read the article for yourself. Some controversial issues are raised that you might be interested learning about. You be the judge.

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Structural Aspects of Biomaterials

Updated June 28, 2023

The original links broke.

You might still be interested in the same topic:

ME C117 Structural Aspects of Biomaterial - YouTube

---  the original post follows below  ---

As a taxpaying Californian, this is a pleasant find. In this free video lecture series, Bio Engineering/ME C117: Structural Aspects of Biomaterials, UC Berkeley Professor Lisa Pruitt provides an overview of medical devices, FDA regulatory issues, biocompatibility and sterilization technology. The lectures examine biomechanical properties: isotropy/anisotropy, stiffness, bending stresses, contact stresses, multiaxial loading, plasticity, fatigue, fracture, wear, corrosion, design issues. There are more than 20 lectures in this series . . .

All the available lectures in this series are found via the link above. I've provided the links to the first 2 lectures in the series:

1. ME C117 Lecture 01: Course Overview
2. ME C117 Lecture 02: Biocompatibility/FDA Regulatory Agency

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Top Picks - Health Self-Monitoring Kits (video)

If you should be monitoring your blood pressure, or your blood sugars, then you need to watch this. This CBS News video shouts out their top picks for blood pressure monitoring, and blood glucose monitoring, "The Top Self-Monitoring Kits." And the top picks are . . . Their Top Blood Pressure Monitoring Kit:

• Omron Elite 7300W Womens Avanced Blood Pressure Monitor

Their Top Blood Glucose Monitoring Kit:

• One Touch UltraMini Blood Glucose Monitoring System Kit - 1 Ea

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GMP News Sources - updated list for free

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Updated March 22, 2022

This is a collection of health, drug, and GMP news and industry publications. Use this to update your knowledge of current events, or to work the latest information and knowledge into your upcoming classroom or training event. This list is provided to you for free.

Biospace Newsfeeds - Biotech and Pharmaceutical News
BioWorld Online - the worldwide biotechnology news and information source
European Compliance Academy Newsfeeds (2022)
FDA WebView - the internet's fastest FDA news center
GMP Trends - an online and printed GMP information source
Health, Drug, Prescription, GMP Supersite - reference additional news sources on the Blog List
Pharmaceutical Business Review - the latest news, comment, and industry information
Pharmaceutical Online - the online industry standard

You might also be interested in the Health & FDA-related news, that displays on this blog's Blog List (just scroll down the left sidebar of this blog).

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Lasik - Pretty Safe . . . AND . . .

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Updated October 28, 2022

You might also be interested in:

Lasik - FDA.gov

---  the original post follows below  ---

 

OK, so I'm a holdout. I should have Lasik eye surgery, and get perfect vision. Reading articles like this one, Look closely before you seek 20/20, allows me to rationalize why I shouldn't get it done. Honestly, this is actually a well-written story. Lasik has gotten better over the years, and a very small percentage of folks end up with problems. I especially like the fact that more ophthalmologists are getting Lasik. That tells me that the technology and advancements have finally matured. Don't let me hold you back, think about getting Lasik! 

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GMP News Sources

• FDA GMP Online Training - respected CGMP online training courses offered by SkillsPlus International Inc.

Updated August 19, 2024:

This is a collection of health, drug, and GMP news and industry publications. Use this to update your knowledge of current events, or to work the latest information and knowledge into your upcoming classroom or training event. 

BioWorld Online - the worldwide biotechnology news and information source
FDA WebView - the internet's fastest FDA news center
Pharmaceutical Business Review - the latest news, comment, and industry information
Pharmaceutical Online - the online industry standard

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