Medical Device Industry In Critical Condition - Forbes Op-Ed

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Updated April 17, 2021

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The U.S. Medical Device Industry is in Critical Condition - Orthostreams.com

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U.S. Medical Device Industry In Critical Condition - Forbes:

"The medical device industry is being ravaged by unwise public policy, including a devastating 2.3% excise tax took effect on Jan 1 as part of ObamaCare. This tax, which has already required the payment of more than $1 billion by device manufacturers, is especially pernicious because it is assessed on gross sales, not profits. To put this in perspective, imagine that you’re a manufacturer of medical devices and had a profit of $100,000 on sales of $1 million after all your costs and expenses—everything from materials and labor to research. The excise tax would be $23,000, wiping out almost a quarter of your profits."

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34 Kids/Day Seen in ER for Choking on Food

34 kids a day seen in ER for choking on food, study finds - NBC News.com:

"... children between the ages of birth to 4 were most likely to choke on food, with hard candy accounting for 15 percent of choking incidents. Other kinds of candy and gum were the culprit behind 13 percent of episodes, followed by meat — not including hot dogs — and bones. Nuts, seeds and hot dogs were the foods most likely to end up in a hospital stay — nuts and seeds because they’re difficult for little teeth to chew and hot dogs because they can be sucked into the airway and cause more serious choking."

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mHealth to see big growth, barriers | Healthcare IT News

mHealth to see big growth, barriers | Healthcare IT News:

"A new mobile health trends report released Wednesday underscores the mid- to low sophistication of current mHealth application technology but also emphasizes the explosive growth and integration headed for the market .

The Research and Markets mHealth trends report shows the industry poised for a compound annual growth rate of 61 percent by 2017, to reach a value of $26 billion. This revenue, researchers project, will be derived predominantly from mHealth hardware sales and services."

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FDA Says - Use Sunscreen Spray? Avoid Open Flame

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Updated July 28, 2021

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FDA reminds consumers spray-on sunscreens can catch fire - CBS News

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Consumer Updates > Use Sunscreen Spray? Avoid Open Flame:

"You love a good summer barbecue and wisely use sunscreen if you are out in the sun. What you may not know is that if you apply certain sunscreen sprays and then come close to a source of flame, you may risk the sunscreen catching fire and giving you a serious burn.

The Food and Drug Administration (FDA) has become aware of five separate incidents in which people wearing sunscreen spray near sources of flame suffered significant burns that required medical treatment."

Follow this link to more FDA Sunscreen resources and information

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FDA Draft Guidance Summarized: Delaying, Denying, Limiting, or Refusing a Drug Inspection

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Updated November 4, 2020

Some the links broke in the original post below.

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FDA Issues Draft Guidance on Definition of Denying, Delaying, Limiting or Refusing to Permit Inspection - The National Law Review

Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection - FDA.gov (PDF)

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Facility Inspection Guidance Issued by FDA: Delaying, Denying, Limiting, or Refusing a Drug Inspection - FDA Lawyers Blog:

" . . . in particular Section 707 of FDASIA, which added 501(j) to the FD&C Act, the FDA now deems as adulterated a drug that "has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection". (emphasis added)"

Read the draft guidance:
FDA - Draft Guidance for Industry - Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (PDF)

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Does Your Dentist or Doctor Use FDA Approved Steam Sterilizers?

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It's frightening to know that there are subpar sterilizers being purchased and potentially being used on the public (for example, by dentists/doctors & tattoo artists). What a public health risk!

Autoclave Manufacturers Make False Claims About FDA Approvals:

"FDA cleared devices follow strict, comprehensive testing models. The testing data is reviewed and approved by FDA prior to marketing. Sterilizers which have not been subjected to the FDA 510K process and marketed in the US could compromise patient safety."

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FDA Patient Network - What We Do

What We Do | Patient Network:

"You can use this Web site to learn more about how FDA works and how you can participate in the drug and medical device approval process."

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FDA Draft Guidance - Mobile Medical Apps - Practical Insights

A quick and insightful perspective on the much anticipated mobile medical app guidance . . .

Compliance Zen: Majority of Mobile Health Apps Class II Devices for FDA:

"FDA’s current draft guidance on mobile medical apps is woefully short of such practical specifics. And yet it’s these specifics that will get even the most forthright medical app developer in trouble with FDA-483s and Warning Letters. Warning Letters have been shown to reduce product sales by at least 8% the first year and for three years thereafter. For many of these developers, a Warning Letter might be the kiss of death and bring a painful chill to the innovation marketplace."

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New FDA Guidance - Cosmetic GMPs

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Updated July 22, 2021

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Cosmetics Guidance Documents - FDA.gov

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Guidance Documents > Guidance for Industry: Cosmetic Good Manufacturing Practices:

" . . . as part of an international harmonization effort with the International Cooperation on Cosmetic Regulations (ICCR), FDA (or we) agreed to consider the current International Organization for Standardization (ISO) standard for cosmetic GMPs (ISO 22716:2007) when revising this guidance. We reviewed ISO 22716 and decided to incorporate, modify, or exclude specific aspects of it into this guidance based on our experience."

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