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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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

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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 - New Process Validation Guidance Document

• FDA GMP QSR cGMP Training - recommended online GMP training courses by SkillsPlus International Inc.

The FDA just published this, FDA - Guidance for Industry - Process Validation: General Principles and Practices (pdf).

In a nutshell, the CGMP regulations require that manufacturing processes be designed and controlled to assure that in-process materials and the finished product meet predetermined quality requirements and do so consistently and reliably.

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FDA Webinar on FDA Inspection Process

When:     Thursday, March 25, 2010, at 2 p.m. ET

Where:    https://collaboration.fda.gov/inspectionprocess/

Host:       FDA’s Office of Regulatory Affairs (ORA), 301-827-3101

             ORAContactUs@FDA.HHS.GOV

Speaker: Michael C. Rogers, deputy director, Office of Regional Operations

To ensure the safety of marketed products, FDA experts inspect domestic and foreign establishments, check shipments of imported products, and collect and test product samples for signs of contamination.

During this webinar, FDA experts will present information on

• the organization within FDA that is charged with conducting inspections
• the facilities FDA is responsible for inspecting
• what an inspection involves
• inspection follow-up and enforcement actions
• the rigorous training that inspectors receive

The presentation will run approximately 30 minutes and will include an opportunity to ask questions.

To join the webinar:

1. Click https://collaboration.fda.gov/inspectionprocess/ (or cut and paste it into your Internet browser)
2. Click "Enter as a Guest," fill in your name, then click "Enter Room"
3. Dial 1-877-685-5350 and enter participant passcode: 969082

You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.

This class prepares plant personnel to participate in an FDA Inspection.

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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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FDA Quality by Design - QbD - Executive Guide (pdf)

According to Cerulean Associates' Why Quality by Design? - An Executive's Guide to the FDA's Quality by Design (pdf), "Quality by Design is one of the most misunderstood and misused tools available to biopharmaceutical and medical device executives." The guide is easily understood and closes by driving to a 7-step QbD start-up plan. According to the guide, "the best way to assess how to implement QbD in your organization without making the same mistakes that other companies have made is to utilize a simple 7 step process."

Here's to hoping you enjoy and find this guide a good read, as I found it.

Related Posts:
Quality by Design (QbD) For Analytical Methods (video)

#FDA #GMP #training #cGMP

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Read Or Download The GAO Report - The FDA And High Risk Medical Devices (pdf)

• FDA CGMP Online Training - trusted FDA GMP online training classes taught by SkillsPlus International Inc.

The FDA and medical device industry just got a wake-up call. Seems like this GAO report suggests greater rigor is needed in the premarket review process, MEDICAL DEVICES - FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process. In any event, seems like this industry sector can expect potentially more rigorous regulation in the future . . . Bottomline, the reports states, "We are recommending that the Secretary of Health and Human Services direct the FDA Commissioner to expeditiously take steps to issue regulations for each class III device type currently allowed to enter the market through the 510(k) process. These steps should include issuing regulations to (1) reclassify each device type into class I or class II, or requiring it to remain in class III, and (2) for those device types remaining in class III, require approval for marketing through the PMA process." From your perspective, would more stringent regulation be a good thing? 

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FDA Draft Guidance On Process Validation

The FDA recently released a draft guidance for new process validation. The guidance says that manufacturers would have to increase sampling and testing, and monitor process performance more closely during the early stages of commercial manufacturing, according to the FDA's Guidance for Industry - Process Validation: General Principles and guidance. Once finalized, this guidance replaces the FDA's process validation guidance issued in 1987. The new guidance applies to pharmaceuticals, biologics and active pharmaceutical ingredients. It will cover the 3 stages of process validation — process design, process qualification and continued process verification. Are you ready? 

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Nice Review of US FDA Medical Device Regulation

This is an excellent introduction to, and review of the FDA's Medical Device Regulations. This report, "Review of U.S. Medical Device Regulation," published in the Journal of Medical Devices, highlights the differences between regulations guiding medical devices versus pharmaceuticals and underscores the complexity of the approval process and post-market surveillance administered by the Food and Drug Administration (FDA). The report tackles the subject in the following sub-topics . . .

1. Introduction
2. Regulatory Definition of Medical Devices
3. Risk-Based Device Classification
4. Safety and Effectiveness Requirements
5. Food and Drug Administration Programs/Regulatory Pathways
6. Quality Systems Regulation (QSR)
7. Regulation of Drug-Device Combinations (Combination Products)
8. Guidance Documents Available to the Device Industry
9. Conclusions

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The FDA Drug Approval Process - free video

Updated May 23, 2025

The original link broke.

You might also be interested in the following FDA video:

https://youtu.be/fZ-Msidi7EE?si=rzphqPYBxwWlPgxV

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For those of you wanting something a little more in-depth, here's this free 24 minute video, produced by peRX (prescribing evidence-based therapies), "Why and how are drugs approved?" Here's what the video presents . . .

1. Overview of drug research and development in the United States, and
2. The FDA drug approval process

A side note about peRX and this video. The peRX site states, "On May 13, 2004, Warner-Lambert, a division of Pfizer, Inc., entered into an Assurance of Voluntary Compliance/Discontinuance with the Attorneys General of 50 States and the District of Columbia to settle allegations that Warner-Lambert conducted an unlawful marketing campaign for the drug Neurontin® that violated state consumer protection laws. Among other things, the settlement provides for a $21 million Consumer and Prescriber Education grant program." The peRX Project is an educational program funded by the Consumer & Prescriber Education grant program.

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The FDA Drug Approval Process

Updated July 15, 2020

The link in the original post broke.

You might also be interested in this:
Development & Approval Process | Drugs (on the FDA.gov website)

- - -  the original post follows below  - - -

I always have to remind myself what's involved in getting a drug to market. This eSSORTMENT article is short, sweet, and a great overview of the process, "The FDA drug approval process - The FDA has an elaborate clinical process that examines new drugs for distribution to the public with its seal of approval." I've seen it stated in some other places I've read, that it can take about 15 years to 'birth' a new drug.

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