Author Archives: admin

Pre-Submission Program – Final Guidance

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On February 18, the FDA issued the final guidance document for the Pre-Submission Program and Meetings with FDA Staff. The Pre-Submission process is a way for industry to get feedback from the FDA prior to the submission of a premarket …

Affordable Breakthrough Innovations

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Innovative ideas for medical devices are often costly for manufacturers to make and for patients to own. However, not all innovative medical devices will cost you an arm and a leg. Health Innovations to Save Women and Children Now featured …

Guidance Documents for 2014

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In an effort to help get safe and effective medical devices to market more quickly, the FDA publishes a list of proposed guidance documents each year. Here is FDA’s prioritized list of things you can expect to see in 2014: “A-list” …

Pediatric Subpopulations – Final Rule

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On Friday, January 10, 2014 the FDA issued a final rule, which amends the premarket approval (PMA) regulations. The final rule requires “submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended …

510(k) Pop Quiz!

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How well do you know the logistics of the 510(k) process? Today’s blog is interactive, as well as educational! Take this quiz (no cheating!). Comment on the post to tell me how many answers you got right! QUESTIONS What does …

3D Printing in Medicine

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As if 3D printers for rapid prototyping weren’t cool enough, researchers at the University of Wollongong and St. Vincent’s Hospital Melbourne, part of Australian Research Council Centre of Excellence for Electromaterials Science (ACES), have been using 3D printing to make some …

Transhumanism – Science from Fiction: Conclusion

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Trans∙hu∙man∙ism /tranz’hyoomənizm// Noun The belief or theory that the human race can evolve beyond its current physical and mental limitations, especially by means of science and technology.1   When I started writing this blog mini-series, I had initially thought that …

Devices for the Military

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This past weekend I travelled to the Chicago-land area to attend my brother’s graduation from Northern Illinois University and commissioning into the US Army. He will be reporting to Fort Leonard Wood, Missouri for officer training as part of the …

Veterinary Medical Devices – FDA Regulations

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I recently worked on a project that involved writing a regulatory strategy for a device used on animals. This was a new area for me and I got interested in learning even more about the topic afterwards. I was curious as to …

Transhumanism – Science from Fiction: Part III – Not So Vulcan Mind Melds

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Not So Vulcan Mind Melds Telepathy and telekinesis is a thing of comic book and sci-fi series history.  No longer do we have to wish that such technologies are available, in order to make us more like our super-hero or …