QA/RA Updates for Medical Device Professionals

FDA Hosts Public Hearing to Address the Internet and Social Media and how they Relate to Product Regulation

The FDA is holding a public hearing on November 12 and 13, 2009 from 8am to 5pm each day to discuss the increasing challenges that social media and the internet have presented to product regulation. The hearing will be at the National Transportation Safety Board Conference Center in Washington, D.C. In addition to the public meeting, the FDA will also accept comments (electronic and hard copy) until February 28, 2010.  By mid December, the transcript for the meeting will be available under the Division of Dockets Management, available online.

Issues that will be discussed include the distinction between when a product is being promoted and when it is being advertised, and the reporting of adverse event data. Further, how often and to what extent companies, consumers, and health care professionals use social media (Twitter, Facebook, wikis, blogs, video sharing, etc) to promote topics of public health and how they are impacted by such promotion will also be examined.

The following discussion questions are a sample of those that will be posed at the public hearing. For more information, visit the official notice in the Federal Register

• For what online communications are manufacturers, packers, or distributors accountable?
• How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, postmarketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., microblogs, mobile technology)?
• What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
• When is the use of links appropriate? (The FDA prohibits manufacturers, packers, or distributors from promoting their product for unapproved uses. This is an issue with use of the internet because providing links, for example, may cause the user to view an unapproved use listed on another site.)
• Questions specific to Internet adverse event reporting (the submission of postmarketing adverse even reports are required by the FDA)

You can submit your comments online on http://www.regulations.gov. When you are on the site, use docket No. FDA-2009-N-0441 to identify your comment.

US FDA may get large increase in funding

Today the Wall Street Journal published an article noting that President Obama has requested an additional $300,000,000 in funding for the US FDA, from $2.06 billion to $2.35 billion. That’s a 14% increase.  If the funding is approved by Congress, the agency will likely hire more inspectors which will lead to more frequent visits from the FDA to medical device manufacturers. The WSJ article quotes: “The FDA’s budget has shrunk or been held flat since the mid 1990s. Mr. Hubbard (with the FDA) said this increase, along with an increase of about $172 million from the previous year, will help the agency hire more inspectors, more scientists…  The budget would bring the FDA’s staffing back to the same levels it had in 1994, the year before the agency’s budget began falling and getting held back.”  Read the full article.

US FDA announces new website

The Food and Drug Administration has said that it plans to launch a redesigned website, presumably in 2009. This should be good news for users of the site. Hopefully, guidance documents and other relevant information will be easier to find, and databases will be easier to use. Here’s the brief announcement. Keep your fingers crossed. http://www.fda.gov/redesign/launch.html

US FDA issues notice on preamendment Class III devices

The Food and Drug Administration (FDA) just posted a notice in the April 9, 2009 Federal Register notifying manufacturers of 25 types of Class III medical devices that their products will be subject to scrutiny soon. The 25 products are all “preamendment” Class III devices that were already being sold on the US market prior to 1976. The manufacturers of devices falling into one of those 25 categories will need to submit more information on their safety and effectiveness before August 7, 2009. The result of this is that some products that have been on the market for 30+ years MAY be subject to the rigorous Premarket Approval (PMA) process, or be down classified to Class I or Class II. You can read more about this on our website, which lists all 25 products and provides links to the Federal Register and FDA notices.

Updated list of recognized Standards published by US FDA

The Center for Devices and Radiological Health (CDRH) within the US Food and Drug Administration has published an updated list of recognized standards used in premarket reviews of medical device submissions. This list is generally updated every 3-6 months by FDA. You can download the most recent list published in the Federal Register.