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 101 Digital Health Guide - Free Rock Health Report

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Does your mobile health app need FDA clearance? Checklist gives guidance for digital health entrepreneurs | MedCity News:

In a report dubbed “FDA 101,” health startup accelerator Rock Health has compiled a handy report to help digital health entrepreneurs assess whether their mobile health apps would be classified as medical devices by the FDA and require 510(k) clearance. Rock Reports - FDA 101 - A guide for digital health entrepreneurs

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FDA Asked About Mobile Apps and the FDA 510K Process

Congress asks FDA if “actual use” is factor in medical app regulation | mobihealthnews:

". . . The letter also asks whether the FDA will consider the “actual use” of a mobile medical app in addition to the “intended use” when making its determination about whether an app needs to go through the 510(K) process. Finally, the letter closes with a series of questions related to the final guidance document and the committee wants answers by March 15th."

'via Blog this'

Read the Letter Sent to FDA Commissioner Margaret Hamburg (pdf)

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Related articles

• FDA Free Tips - Don't Fall for Health Fraud Scams (video) (drughealth.blogspot.com)

CDRH Learn Course List (Spanish)

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

It's great to see the FDA continue to expand their free training offerings, especially these in Spanish

CDRH Learn Course List (Spanish)
Listed below are the courses CDRH currently offers in Spanish. Additional online courses are being developed.

Course List

1. Overview of Regulatory Requirements: Medical Devices [New! 9/2]
2. Quality System Regulation 21 CFR Part 820 Basic Introduction
3. Export Certificates for Medical Devices
4. Overview of the Premarket Notification Process - 510(k)
5. Bioresearch Monitoring (BIMO) [New! 7/25]
6. Medical Device Reporting

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FDA Should Revamp 510(k) Medical Device Clearance Process

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Updated November 4, 2022

Some of the links broke.

You can still read about the same topic here:

Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years - NAP.edu

---  the original post follows below  ---

The LA Times reports, FDA is urged to revamp its review process for medical devices.

In a nutshell, the Institute of Medicine (IOM), an arm of the National Academy of Sciences (NAS), recommended that the system be abolished and new procedures established, IOM - Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.

Webcast of the Institute of Medicine - Public Health Effectiveness of the FDA 510(k) Clearance Process - Public Briefing (July 29, 2011)

FDA Controversy - Regen Biologic's Menaflex Device

The FDA is reassessing the safety of a device (Regen Biologic's Menaflex Device) that it previously approved for patients. The FDA conducted a March 23, 2010: Orthopaedic and Rehabilitation Devices Panel Meeting. Although the panel expressed that they would have liked to have seen more data on the device, they largely backed it as a safe and effective therapy.

The larger looming issue now is whether this will become precendent setting and raise the prospect of FDA re-evaluating previously approved devices.

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FDA Medical Device Online Courses In Chinese - Free

Here's more from the FDA's CDRH Learn treasure trove of free online courses. ... and these are in Mandarin Chinese! As of this posting, there's only one FDA CDRH Learn course in Mandarin, but you can expect more courses to be on their way. Here's what's available so far: Quality System Regulation 21 CFR Part 820 Basic Introduction Online Video Presentation Transcript 

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FDA Medical Device Online Courses - Free

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This is a great example of your government dollars working for you.

The FDA offers several free CDRH Learn online courses. These courses are intended for industry on safety and effectiveness of medical devices and exposure to radiation from medical devices.

Here's what's neat about the courses. Each course includes a captioned video, slide set, and post-test.

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FDA Medical Device Controversies - Approvals and Clearance

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I thoroughly enjoyed reading this Health News Digest article, Is That Medical Device Safe And Effective? Who Knows? It's a great overview of:

• medical device classification
• premarket approval (PMA)
• premarket notification (510(k))
• substantially equivalent
• anecdotes that highlight controversies in the items above. This is the best part of the article.

For me, I get the sense that it's generally about business, and that some unethical companies might be putting our collective safety at risk.

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Is FDA Watching Over Cell Phones as Medical Devices?

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Updated March 24, 2021

People also search for the:

Digital Health Center of Excellence - FDA.gov

---  original post follows below  ---

Lately at work I've been noticing some buzz about mHealth, mobile health. The intersection of mHealth, cell phones, and FDA regulation of medical devices seems to be happening, reports this Bob on Medical Device Software post, When Cell Phones Become Medical Devices. According to the post:

Mobile devices are quickly becoming the conduit of choice for collecting and disseminating clinical data. The FDA will soon be forced to step in and take regulatory control. It’s going to happen eventually.

In a nutshell, it's time to start watching this, and paying attention to the possibility of having to follow FDA medical device regulations.  

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FDA Draft Guidance on Injectors

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To address the increasing popularity of drug-injector systems, the FDA (Food and Drug Administration) released a draft guidance, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products. 

The draft guidance applies to, but is not limited to, jet, pen, needle-free, and mechanically operated injectors as well as piston syringes and injectors with computerized or electronic elements. Injectors are categorized into three groups: those intended for use with a wide range of currently marketed drugs or biological products, those intended for use with a specific class or product line, and those intended for use with a specific product. 

 The FDA is providing this draft guidance document to assist industry in developing technical and scientific information to support a marketing application for a pen, jet, or related injector device intended for use with drugs and biological products. The marketing application would typically be a premarket notification submission (510(k)) or a premarket approval (PMA) application for the injector alone. 

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Avoid FDA 510k Medical Device Clearance Mistakes - 5 Free Tips

It's better to know what's needed upfront, than to get hung up at the last moment in the 510k process. "FDA medical device approval, also known as the FDA 510k process, can easily take much longer than anticipated due to common mistakes or omissions. Here are five tips to avoid some of those mistakes," reports Nicolaas Besseling in, "Five Tips for Quick FDA 510k Clearance for Medical Devices." In a nutshell . . .

1. Find out if the FDA regulates the device
2. Make sure the classification of the device is correct
3. Determine who will be the owner of the 510(k), and who will be the official correspondent
4. Use (a) predicate device(s) that is close to the new device
5. Pay close attention to the formatting of the submission

Following the 5 tips above won't necessarily guarantee success because there are many nuances and traps to avoid. If you're not expert in 510k filings, you might want to consider partnering with an industry consultant.

Related Posts:
Read Or Download The GAO Report - The FDA And High Risk Medical Devices (pdf)
FDA 510(k) Free Tips And Pearls Of Wisdom
Medical Devices - A murky 510(k) world?!

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cGMP basics training for newbies and seasoned staff

#FDA #GMP #cGMP #training #course #class

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Medical Device Sponsors - FDA Trends and Tips To Avoid 483s

Updated November 5, 2024

The original link broke

You might also be interested in this article by the same author, Carl Anderson:

The FDA 483 - https://carl1anderson.wordpress.com/wp-content/uploads/2009/03/the-fda-483.pdf

---  the original post follows below  ---

The Division of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration, released inspection statistics for the 2007 fiscal year. The statistics for the 40 Bioresearch Monitoring (BIMO) inspections of medical device sponsors showed serious concerns for compliance with good clinical practice (GCP) regulations. Author Carl Anderson explains the CDRH findings, identifies problem areas to avoid, and gives tips on how to avoid 483s, in his article, "Trends in FDA CDRH Bioresearch Monitoring Inspections." The following are the topics he covers in the article . . .

• About the Division of Bioresearch Monitoring Organization at CDRH
• Medical Device Sponsor Inspections
• Quality Systems in Clinical Trials
• Implications of BIMO Inspection Statistics - with a top 5 category list of deficiencies

Don't get caught flat-footed. Reading this article will help you steer clear of choppy waters, warnings, and 483s.

Related Posts:
More FDA 483 Resources - Comments and Pearls from Validation Online
FDA 483 Inspectional Observations - learn from these examples

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FDA 510(k) Free Tips And Pearls Of Wisdom

Updated July 6, 2023

The original links broke.

You might also be interested in:

510(k) Clearances - FDA.gov

---  the original post follows below  ---

If you're working on a 510(k) medical device submission, you might want to peek at this Medical Device Blog post that's full of great tips for avoiding heartaches, "510(k) Approval Timeline." There's some really good stuff there. Did you find those tips helpful? If you need more info, try the FDA's own site . . . The FDA's Information on Releasable 510(k)s: General Information Federal Register Notices Search the Releasable 510(k) Database Listing of CDRH Substantially Equivalent (SE) 510(k) Summaries or 510(k) Statements, for Final Decisions Rendered Downloadable 510(k) Files One gem is the FDA's "SCREENING CHECKLIST - ALL PREMARKET NOTIFICATION [510(k)] SUBMISSIONS" (free) that's used to assess whether your paperwork is complete enough or not for a substantive review. 

Previous 510(k) Posts: Medical Devices - A murky 510(k) world?! Medical Devices Containing Antimicrobial Agents - FDA Guidance Pending 

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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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Medical Devices Containing Antimicrobial Agents - FDA Guidance Pending

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Updated October 22, 2020

The link in the original post is no longer valid.

You might be interested in the guidance document:
Draft Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents (withdrawn 08/03/2018)

- -  original post follows below  - -

Here's a late-breaking scoop from FDA Legislative Watch, "FDA Finalizing Guidance For Devices Containing Antimicrobial Agents." Reportedly, revisions to a draft guidance on 510(k) submissions for devices or combination products that incorporate antimicrobial agents are awaiting final sign-off at the FDA. Apparently, one of the biggest issues for debate is whether a device is substantially equivalent to a marketed product with the same design, or whether it is a modification. Bottomline, modified devices require much more data.

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Wow! This New Home TeleHealth Device Brings The Future Closer

The future keeps getting closer. I never knew Intel had a hand in the home health care management arena for folks with chronic medical conditions. The FDA just approved their Intel Personal Health System. This is really exciting for me to read because over the last couple of decades, health care systems have attempted to connect to patients in their home via telemedicine or video devices with various degrees of success. What's going to be really important is how these kind of devices will get integrated with what will become the power players in the personal health record space. What I mean is, offerings like Google Health, and Microsoft HealthVault.

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