FDA Should Revamp 510(k) Medical Device Clearance Process

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)

Related articles

• Study Faults Approval Process for Medical Devices (nytimes.com)
• 510(k) approval process is 'too big to fail - no matter how flawed it may be (medcitynews.com)
• Flawed Medical Device Approval Process Needs Public Comments, Says The FDA (medicalnewstoday.com)

FDA Finds Faked Documentation At Cetero

This is a really good example of how improper documentation practices can get a company into real trouble.

Read this Reuter's release, FDA finds drug research firm faked samples, documents.

In a nutshell:

"The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame," the FDA said, warning drugmakers they might have to repeat or confirm any studies Cetero did in support of their applications between April 2005 and June 2010.

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Related articles

• FDA Finds U.S. Cetero Research Falsified Records About Drug Studies-Probably Hidden in the Algorithms Used for Reporting (ducknetweb.blogspot.com)
• FDA says CRO Cetero faked trial data; pharmas may need to redo tests (medcitynews.com)

What?! No Hot Dogs! ... But I Love Them!

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Today is National Hot Dog Day, yay!   I love a good hot dog every now and again.

However, the D.C.-based Physicians Committee for Responsible Medicine bought a billboard that tells me that "hot dogs can wreck your health." 


What's worse, I guess all those other processed meats that I love will catch up with me too! (bacon, sausage, ham, deli meats, pepperoni)

FDA Issues Guidance For Mobile Medical Applications

The U.S. Food and Drug Administration (FDA) announced it is seeking input on its proposed oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications ("apps") that are designed for use on smartphones and other mobile computing devices. This approach encourages the development of new apps, focuses only on a select group of applications and will not regulate the sale or general consumer use of smartphones or tablets.

Today, mobile medical applications or "mobile medical apps," include a variety of functions, ranging from monitoring calorie intake, helping people maintain a healthy weight, and allowing doctors to view a patient’s radiology images on their mobile communications device. According to Research2Guidance 2010, 500 million smartphone users worldwide will be using a health care application by 2015.

"The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery," said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. "Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended."

The agency’s draft guidance defines a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices. This subset includes mobile medical apps that:

A. are used as an accessory to medical device already regulated by the FDA

(For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet); or

B. transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices

(For example, an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack).

For more information:

FDA: Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications

FDA: Consumer Update - FDA Proposes Health 'App' Guidelines

FDA:  Mobile Medical Applications

Related articles

• Health care apps under FDA scrutiny (nvmedtech.com)
• FDA to Review Medical Smartphone Apps (readwriteweb.com)
• Mobile Medical Apps Supervision By FDA, Agency Seeking Input (medicalnewstoday.com)
• FDA seeking to regulate mobile medical apps (news.cnet.com)

Serious Gaps in US Drug Safety

This caught my eye in the National Journal, Pew Study Finds Gaps in FDA Oversight of Imported Drugs.

In a nutshell, Pew Finds Serious Gaps in Oversight of U.S. Drug Safety points to the Pew white paper that finds that increased outsourcing of manufacturing, a complex and globalized supply chain and criminal actors create the potential for counterfeit or substandard medicines to enter the supply chain and reach patients.

Related articles

• What is Supply Chain Risk Management, Exactly? Stepping Back to Address the Challenge (spendmatters.com)

Free BMI Calculator - No, I'm Not Too Skinny!

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The other day, someone was giving me grief because they thought I might be too skinny.

I just had to comfort myself by finding a body mass index (BMI) calculator to confirm that I'm just right.

Turns out, I'm in the normal range, according to The National Heart, Lung, and Blood Institute (NHLBI), and their webpage, NHLBI - Calculate Your Body Mass Index.

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