FDA proposes changes to biological review of medical devices

English: Logo of the . (Photo credit: Wikipedia)

The FDA has issued draft guidance intended to help companies prepare regulatory submissions for devices that come into contact with the human body directly or indirectly. The guidance, which is up for comment until July 22, outlines changes to how the international standard ISO-10993 should be used to identify possible toxicity issues tied to those devices.

View Full Article in: Clinica (subscription required)

 

 

 

Related articles

• FDA Proposes Mandatory Cancer Warning Labels For Tanning Beds (hngn.com)
• Know the Risks of Indoor Tanning (fda.gov)
• What’s behind the FDA’s push for more patient engagement (hint: it’s not that everyone else is doing it) (medcitynews.com)
• Debate: The FDA’s Caution Is Hazardous To Our Health (fora.tv)
• FDA Wants To Increase Budget By Nearly $1 Billion, 94% Coming From Drug Industry – 11 May 2013 (lucas2012infos.wordpress.com)
• FDA accepts Biogen’s application for hemophilia A candidate (bizjournals.com)
• If Tanning Beds Were a Drug, They’d Be Illegal (forbes.com)

Publications: Ask an Expert about Off-Label Promotion By Sara Dyson, Esq.

Question:  What risk management precautions should a firm take if significant sales are derived from off-label use of its drug or device?

 

Sara Dyson, Esq.

Answer: Promoting medical devices and drugs for uses that have not been approved by the Food and Drug Administration (FDA) constitutes off-label promotion, which is forbidden by the Federal Food, Drug and Cosmetic Act (FDCA).  Companies that promote off-label face severe criminal and civil penalties.  In recent years, off-label promotion has been the subject of countless Warning Letters, cost the industry billions in fines, led to jail time for company executives, resulted in Corporate Integrity Agreements and Deferred Prosecution Agreements, and triggered costly products liability lawsuits.  Yet, even so, many medical device and drug companies continue to profit significantly from the off-label uses of their products.

Read more here…

 

 

Food and Drug Administration logo (Photo credit: Wikipedia)

Related articles

• Update on the Status of the FDA’s Regulation of Mobile Apps (projecthealthdesign.typepad.com)
• Public Agencies Can Address The Obesity Epidemic (medicalnewstoday.com)
• Is limited social media guidance from FDA resulting in more violations for pharma? (medcitynews.com)
• When Is Off-Label Use Not Off Label? (druganddevicelaw.blogspot.com)
• Federal mHealth Policy 101 (slideshare.net)
• Freeman Dyson speaks out about climate science, and fudge (wattsupwiththat.com)
• Monster Energy Drinks: FDA Food Label Requirements v. FDA Dietary… (prweb.com)
• Freeman Dyson Answers Questions (science.slashdot.org)
• 1.02 Where There’s a Will, There’s a Fae (aceofflamingos.wordpress.com)

WEBINAR: The AdvaMed Code of Ethics: What it Means for the Industry & Your Company

Wednesday, May 22, 2013 at 2:00 PM EDT

Andrew Van Haute, Esq. is Associate General Counsel of Advanced Medical Technology Association (AdvaMed).

Interactions between health care professionals and medical technology companies fuel the advancement of new technology and improve the quality of medical care through training and education. However, it is important that these relationships never cross the line to impropriety, particularly in today’s age of the Sunshine Act and state and federal anti-kickback regulations. Even the appearance of misconduct in this respect can have serious regulatory, products liability, and even criminal consequences for life sciences companies. The AdvaMed Code of Ethics provides guidance and a set of standards for companies to follow in order to ensure that their interactions with healthcare professionals are appropriate, and thus that the healthcare professionals’ selection of particular products are only reflections of their independent medical judgments and cannot be attributed to the influence of company personnel.

This webinar will address:

• What the AdvaMed Code of Ethics is and what it covers
• The impact the Code has had on life sciences companies
• How its implementation can help your company

Register and learn more here…

Related articles

• Medical device makers push against new tax (poststar.com)
• #AdvaMed2013 Now Accepting Company Presentations & Panel Submissions (ibiojohn.wordpress.com)
• #AdvaMed2013 Now Accepting Company Presentations (catalyzingillinois.com)
• Hologic Appoints Scott Garrett to Board (pehub.com)
• Legislative Train Wrecks – ACA’s Medical Device Tax (ceosforliberty.wordpress.com)
• US HealthConnect Acquires Assets of Complemedia, Broadening Its Technologies with Mobile Apps, Mobile-to-Web Interfaces, App Codes, and Tools to Enable Mobile Education (prweb.com)
• Handy Photo for iOS and Android Now Available on the Apple App Store and the Google Play Store (prweb.com)
• ADVA Optical Networking Q1 2013 Financial Results Conference Call Information (sys-con.com)
• US HealthConnect Acquires Assets of Complemedia, Broadening Its… (prweb.com)
• Medical Device Sales – The Book of Knowledge is Expanding (business2community.com)