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

• Recommended FDA CGMP online training courses taught by SkillsPlus International Inc.

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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The Exemptee Institute
The Designated Representative Institute

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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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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 - CDRH 2011 Strategic Priorities

Another post on what you can expect in 2011.

The FDA's CDRH (Center for Devices and Radiological Health) published the broad strategies that they will implement in 2011 in alignment with four priority areas. It includes timeframes associated with each strategy, and specific actions they will take to meet those goals or make significant progress in 2011 achieving those goals.

The 4 priority areas are:

1. Priority 1. Fully Implement a Total Product Life Cycle Approach
2. Priority 2. Enhance Communication and Transparency
3. Priority 3. Strengthen Our Workforce and Workplace
4. Priority 4. Proactively Facilitate Innovation and Address Unmet Public Health Needs

Source:   FDA - CDRH 2011 Strategic Priorities

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Free QSR Training (video)

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Updated April 13, 2021

The original links broke.

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An Introduction to FDA's Regulation of Medical Devices - FDA.gov

PresentationExternal Link Disclaimer   Printable Slides   Transcript

---  the original post follows below  ---

According to the FDA, the quality system regulation includes requirements related to the methods used in and the facilities and controls used for: designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices. Manufacturing facilities undergo FDA inspections to assure compliance with the QS requirements.

Checkout this free training offering by the FDA, Quality System Regulation 21 CFR Part 820 Basic Introduction (video).

Here's what you get with the complete course offering:

1. Quality System Regulation 21 CFR Part 820 Basic Introduction - Online Video Presentation (with Captioning)
2. Quality System Regulation 21 CFR Part 820 Basic Introduction - Printable Slide Presentation

You might also be interested in:

Essentials for Medical Device Manufacturers - a training class by SkillsPlus International Inc.

Teaches employees the essential elements of QSR for beginning work in the medical device industry

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FDA Draft Guidance - Medical Device ISO - Voluntary Audit Report Submission Program

The Federal Register notice just announced the availability of the FDA Draft Guidance for Industry, Third Parties and FDA Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program.

The medical device ISO 13485:2003 Voluntary Audit Report Submission Program outlined in this draft guidance is another way in which FDA may leverage audits performed by other Global Harmonization Task Force (GHTF) regulators and accredited third parties in order to assist the agency in setting risk-based inspectional priorities.

The FDA recommends that a domestic or foreign device manufacturer that is subject to the requirements in 21 CFR Part 820, Quality System (QS) regulation be eligible to participate in the ISO 13485:2003 Voluntary Audit Report Submission Program under certain circumstances described on the FDA webpage (link provided above).

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Free FDA QSR Basic Intro Course In Spanish - Espanol

Kim Trautman of the FDA CDRH’s Division of Enforcement B, Office of Compliance, provides a basic FDA overview course on the Quality System Regulation covered in 21 CFR 820 in Spanish (free).

The course covers the material with spoken and written Spanish (Espanol).

Another fine offering from the FDA.

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FDA CDRH Announces Strategic Initiatives

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Updated Dec 7, 2015:
The link in the original post went stale. You might be interested in:
FDA CDRH Strategic Priorities and Updates

- - - -  original post follows below - - - -

There's a lot here. I recommend you view this or download the FDA PDF, CDRH FY 2010 Strategic Priorities.

Here's what you'll find:

Executive Summary
Priority 1. Fully Implement a Total Product Life Cycle Approach
Strategy 1.1. Enhance and Integrate Premarket, Postmarket, and Compliance Information and Functions
Strategy 1.2. Improve Guidance and Regulation Development
Strategy 1.3. Develop a Cross-Center Compliance Strategy
Priority 2. Enhance Communication and Transparency
Strategy 2.1. Develop a Strategic Approach to Public Communication
Strategy 2.2. Improve Internal Communications
Strategy 2.3. Increase Transparency in Decision Making
Priority 3. Strengthen Our Workforce and Workplace
Strategy 3.1. Recruit, Develop, and Retain High-Quality Employees
Strategy 3.2. Leverage External Expertise
Strategy 3.3. Establish Pathways for Resolving Differences of Opinion
Strategy 3.4. Improve Internal Administrative Processes
Strategy 3.5. Make CDRH's White Oak Facilities More Workplace-Friendly
Priority 4. Proactively Facilitate Innovation and Address Unmet Public Health Needs
Strategy 4.1. Foster Development of Medical Devices to Respond to Unmet Public Health Needs
Strategy 4.2. Develop a Personalized Medicine Program

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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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Our most popular course

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FDA - New CDRH Event Problem Codes

The FDA just published "CDRH Event Problem Codes. This CDRH website (with enhanced device and patient problem codes) provides you a PREVIEW to the updates that will be going live July 1, 2009. The FDA provides this information in advance to help you familiarize yourselves with Event Problem Code updates BEFORE the new codes ‘go live’ and are accepted in MAUDE. It's important to note that on July 1, 2009 - CDRH will begin accepting the updated codes. DO NOT submit these updated codes prior to that time because they will be rejected. Until that time FDA says to continue to use the current Event Problem Codes. April 2, 2010 is the target date to reject all inactivated and retired codes specified in this FDA update. The CDRH Event Problem Code initiative results in part, with updates to codes to reduce manufacturer reporting burden, improve adverse event report quality, and improve FDA’s ability to respond to device-related adverse events. 

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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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FDA CDRH Online Courses (Free)

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Very exciting! Check out these free courses at the CDRH Learn site. Here's why you want to go there . . .
CDRH Learn is the FDA’s Center for Devices and Radiological Health (CDRH) Web page for industry education. CDRH is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational and consumer products.

CDRH Learn offers training modules describing many aspects of medical device and radiological health regulation, covering both premarket and postmarket issues.
Expect more training modules to get released, and eventually associated post-tests.

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Mercury-Containing Dental Fillings - Health and Environmental Concerns

Updated June 26, 2024

The original links broke.

You might also be interested in:

Dental Amalgam Fillings - FDA.gov

---  the original post follows below  ---

Dental amalgam. You might also know these as mercury containing dental fillings. I've got them, you've got them, we've all got them. Yesterday there was a bit of a brouhaha over them in a hearing in Washington DC, Dental Industry Gets An Earful On Mercury. The hearing considered whether dentists should be required to keep pieces of fillings from getting into public wastewater, using special equipment. In any event, the hearing created opportunities for legislators to attack the dental industry on the purported health risks of having mercury-containing fillings in your mouth, and the ramifications of mercury getting into wastewater. If you're interested in the health risk aspect of this, I recommend this page on the FDA's website, Questions and Answers on Dental Amalgam. On a personal closing note, I rotted my teeth on childhood candy, resulting in amalgams in all my teeth; thankfully now, I have a mouthful of caps and crowns, and only one remaining amalgam.

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