Stethoscopes Do As Much Dirty Work As Hands In Spreading Germs : Shots - Health News : NPR

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Stethoscopes Do As Much Dirty Work As Hands In Spreading Germs : Shots - Health News : NPR:

"But while there are guidelines that recommend that all doctors wash their hands before and after visiting each patient, there are none mandating that small medical equipment like stethoscopes should also be disinfected after every single use."

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Hackers break into networks of 3 big medical device makers - SFGate

Hackers break into networks of 3 big medical device makers - SFGate:

"Hackers have penetrated the computer networks of the country's top medical device makers, The Chronicle has learned.

The attacks struck Medtronic, the world's largest medical device maker, Boston Scientific and St. Jude Medical sometime during the first half of 2013 and might have lasted as long as several months, according to a source close to the companies.

It's not clear what exactly the hackers were after, but federal laws meant to safeguard medical information require the companies to disclose any breach involving patient information. The companies have made no such disclosures."

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Overhaul of CDRH's Office of Compliance Creates Six-Division Structure, New Advertising Office

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Follow the link below to see who's going to be in charge . . .

Overhaul of CDRH's Office of Compliance Creates Six-Division Structure, New Advertising Office - RAPS:

"The Center for Devices and Radiological Health (CDRH), the US Food and Drug Administration's (FDA) medical device regulation and compliance-enforcement body, has announced that it has reorganized its Office of Compliance (OC) with the stated goal of better aligning its resources to its mission."

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FDA > Decorative Contact Lenses: Is Your Vision Worth It?

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Updated August 11, 2023

The original link broke.

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Colored and Decorative Contact Lenses: A Prescription Is A Must - FDA.gov

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Consumer Updates > Decorative Contact Lenses: Is Your Vision Worth It?:

"But before buying decorative lenses, here’s what you should know:

They are not cosmetics or over-the-counter merchandise. They are medical devices regulated by the Food and Drug Administration (FDA). Places that advertise them as cosmetics or sell them without a prescription are breaking the law."

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Mobile Medical Applications: Guidance Finalized - FDA Law Blog

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FDA Law Blog: Mobile Medical Applications: A Thoughtful Guidance Is Finalized:

"The final guidance is similar to the draft guidance – but with improved clarity. Hence, it has expanded from 29 to 43 pages. Most of the additional pages are appendices with examples and other supplementary information. This guidance is sensible and well written."

Follow this link to the Mobile Medical Applications - FDA Guidance for Industry and Food and Drug Administration Staff (PDF)

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Medical Device Industry In Critical Condition - Forbes Op-Ed

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Updated April 17, 2021

The original link broke.

You can still read a similar article here:

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

---  the original post follows below  ---

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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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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FDA - Mobile Medical App Guidance - Will it be delayed?

Final days of waiting for FDA mobile medical app guidance? | mobihealthnews:

"Now, on the eve of the FDA’s publication of the final guidelines, the Bipartisan Policy Center and companies that include McKesson, Microsoft, Oracle, athenahealth, Epocrates, Siemens, UnitedHealth Group, Teladoc, the Silicon Valley Chapter of Health 2.0 and StartUp Health have asked HHS to delay the FDA’s final guidelines on mobile medical apps until the workgroup [FDASIA workgroup] finishes."

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Medical Device Tax Repeal Applauded

Medical Device Manufacturing Coalition Applauds Passage of Medical Device Tax Repeal Amendment | MedicalDevices.org:

"“Today’s overwhelming support of the amendment shows that clear majorities in the Senate and the House of Representatives recognize that the medical device tax needs to be repealed so that America’s medical technology community can spur growth and create the great jobs that come along with it,” said Mark Leahey, President and CEO of MDMA. “Every day innovators in this dynamic industry are looking at how to improve the quality of life for patients, and the medical device tax is standing in the way of progress and threatening America’s leadership position. While we have more work to do, MDMA applauds this important step towards ensuring that the United States remains the global leader in medical technology innovation.”"

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Device-Makers Critical of Medicare Competitive Bidding

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Device-makers slam Medicare competitive bidding expansion - The Hill's Healthwatch:

"The medical-device lobby is railing against a new expansion of Medicare's competitive bidding program for durable equipment, a policy projected to save billions of dollars for beneficiaries and the Part B Trust Fund by 2022.

The Advanced Medical Technology Association (AdvaMed) said that the expansion could deprive patients of their preferred medical tools and tests.

"The competitive bidding program is built in such a way that the lowest bid — which may not be the right bid — may compromise patient access to products best suited for their needs," AdvaMed President Stephen Ubl said Thursday in a statement. "

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The Only Vote That Counts: FDA 483 Round-Up

The Only Vote That Counts: FDA 483 Round-Up:

"Looking at the FDA isn’t much different. Lots of folks like to predict what the FDA will do, or try to glean trends from the often cryptic public statements FDA officials make at conferences or other gatherings.  But the FDAs real “votes” are in the 483s they issue.

Reading through a recently-released crop of the agency’s medical device letters, it looks like the FDA is maintaing an interest in CAPA and employee training."

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ECRI Names Top 10 Health Technology Hazards for 2013

ECRI Names Top 10 Health Technology Hazards for 2013 | HITECH Answers:

"What topics made the list?  Here’s the rundown:

1. Alarm hazards
2. Medication administration errors using infusion pumps
3. Unnecessary exposures and radiation burns from diagnostic radiology procedures
4. Patient/data mismatches in EHRs and other health IT systems
5. Interoperability failures with medical devices and health IT systems
6. Air embolism hazards
7. Inattention to the needs of pediatric patients when using “adult” technologies
8. Inadequate reprocessing of endoscopic devices and surgical instruments
9. Caregiver distractions from smartphones and other mobile devices
10. Surgical fires

Of particular interest to us is that for the first time, three Health IT-related topics made the Institutes annual list."

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FDA regulators face daunting task as health apps multiply

Jenny Gold reports that, "In fact, there are 40,000 medical applications available for download on smartphones and tablets — and the market is still in its infancy. But that growth is in the cross hairs of new regulatory efforts from the Food and Drug Administration."

FDA regulators face daunting task as health apps multiply – USATODAY.com:

"Franko's goal is to make sure doctors and patients know what they're getting as quickly as possible. "These apps already exist," he says, "and people are using them in hospitals to make medical decisions, but no one knows if they're actually doing what they claim to be doing.""

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This is all about mobile, tablet, digital technologies intersecting the FDA's QSR regulations applicable to medical device manufacturers (i.e., 21 CFR 820).

You might also be interested in:
Essentials for Medical Device Manufacturers - Recommended QSR Training - SkillsPlus Intl Inc.
21 CFR 820 Essential Elements - The Best Online QSR Training - SkillsPlus Intl Inc.

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Device Manufacturing 101: Orthopedic Implants and Instruments

Updated May 31, 2025

One of the links broke.

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Popular FDA cGMP online training classes, programs, and courses by SkillsPlus International Inc.

---  the original post follows below  ---

. . .  and don't forget about all the FDA's QSR regulations that have to be followed!

Device Manufacturing 101: Orthopedic Implants and Instruments:

". . . have you ever wondered about the steps that go into manufacturing these devices? There’s a lot of work in the process that turns an idea into an actual physical product, and often times it’s something we don’t think about.

During our recent trip to Northeast Indiana, we had the opportunity to visit a number of manufacturing sites and learn the high-tech processes and technology that go into producing orthopedic implants and instruments. Here’s how it works!"

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2012 Crystal Ball Predicts a More Aggressive FDA

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Updated February 2, 2021

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- - -  the original post follows below  - - -

2012 Crystal Ball Predicts a More Aggressive FDA:

"According to the FDA website, 2012 will be a year of global regulatory operation and enforcement with emphasis on medical devices, drugs, and food products. "

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The article references:

The FDA Pathway to Global Product Safety and Quality

It's hard to believe 2011 is nearly over, and 2012 is around the corner.  Here's to future trends!

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FDA CDRH Learn - CDRH Learn Spanish Language Course List

FDA CDRH Learn; CDRH Learn Course List (Spanish):    'via Blog this'

The FDA CDRH offers the following courses in Spanish:

• Overview of Regulatory Requirements: Medical Devices
 [New! 9/2]

• Quality System Regulation 21 CFR Part 820 Basic Introduction

• Export Certificates for Medical Devices

• Overview of the Premarket Notification Process - 510(k)

• Bioresearch Monitoring (BIMO)
 [New! 7/25]

• Medical Device Reporting

According to Wikipedia's Languages of the United States, approximately 10% of the US population speaks Spanish.

Hope you find these free FDA resources helpful.

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FDA Approves New Device - Screens for Melanoma

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Image via WikipediaUpdated 9/6/2013:

The original link broke.

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New device uses light to screen for melanoma - NBC News

- - - - -

The Associated Press: New device uses light to screen for melanoma:    'via Blog this'

"The Food and Drug Administration (FDA) approved a first-of-its-kind device, called MelaFind, that makes detailed, digital images of skin growths and uses a computer to analyze them for signs of cancer, offering a sort of second opinion to doctors. The device is approved only for dermatologists and only for use on growths that don't have obvious signs of cancer but still have one or two worrisome traits."

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FDA Awards Two New Regulatory Research Centers

Image via WikipediaFDA launches two centers to improve approval of drugs, devices - The Hill's Healthwatch:  'via Blog this'

"The Food and Drug Administration (FDA) on Wednesday awarded $2 million to support the creation of research centers tasked with improving the way new medicines and medical devices are reviewed and evaluated."

The centers will be established at the University of Maryland and Georgetown University.

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Should Mobile Medical Apps Require FDA Approval?

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Updated June 10, 2021

The links in the original post broke.

You can read more about this topic here:

Device Software Functions Including Mobile Medical Applications - FDA.gov

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Should Mobile Medical Apps Require FDA Approval? - Healthcare - Mobile and Wireless - Informationweek:  

Mobile Medical Apps Meet The FDA, Part 2 - Healthcare - Mobile and Wireless - Informationweek: 

A nice pair of articles, fairly and delicately balancing how much is enough, versus too much FDA regulation.

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Surviving FDA Enforcement Actions - Free Tips

Life in FDA’s fast lane | News | Packaging World:  'via Blog this'

In the article, LeeAnn Rogus offers many tips. Here's just one of the many pearls of wisdom that's shared:

"The 15 days FDA gives a company to respond to a Form 483 inspectional observation has always existed, but the agency would usually let you have extra time. Not any more."

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