QA/RA Updates for Medical Device Professionals

PMDA Issues List of Pre-Market Certificates Issued by RCBs in Japan

The PMDA has just recently released a spreadsheet enumerating the pre-market certificates issued by each of the 12 Registered Certification Bodies (RCBs) sanctioned under the Pharmaceutical Affairs Law (PAL), Article 23. This release was in response to a request from the Ministry of Health, Labor, and Welfare (MHLW) to improve the transparency of the agency. 

The data covers the certificates issued for each model of designated controlled medical devices, which are low risk, Class II devices, from April 2008 through November 2009.  It is important to note that as a result of issuing separate certificates for each model, rather than one for each device family, the total number of certificates issued is high: 3,520 during a 19 month period.

House Increases FDA Funding for Medical Devices

The US House of Representatives has passed a bill that will increase funding for the FDA’s Center for Devices and Radiological Health (CDRH), to US$315M in fiscal year 2010. Industry exponents and lobbyists have praised the efforts for the advancement of the device industry, but the increase falls below the $350M originally sought. Still, the $35M boost is welcomed and represents a 12% increase over fiscal year 2009. What’s left? The bill must be approved by the Senate and signed by President Obama, but opposition is not expected. What a propitious move for the device industry- hopefully this is augury for a good new year!

Faster medical device approval times in Japan may be in store

As part of Japan’s Five Year Action Plan, Japan has set goals for specific in-house improvements to ease the process of obtaining clearance from the Pharmaceuticals and Medical Devices Agency (PMDA) and reduce lengthy review times. The PMDA hopes to more than double their review staff by 2013 and is establishing three distinct review divisions for “brand new” devices, improved versions of “existing” devices and “me-too” devices.

What does this mean for review times? At present, review of brand-new devices takes approximately 21 months; with the increase in staff, and improved efficiency of the process, that number is planned to drop to 14 months by 2013. Similarly, the goal is to shorten the review time for “improved” devices from 16 (or 11 if no clinical data) to 10 months, and “me-too” products from 8 to 4 months.

We will pass along more information on this as it becomes available.

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.

Health Canada to require STED format for Class 3/4 medical device submissions

Health Canada just put out an official notice that they are going to require the STED format for most Class 3 and Class 4 medical device license submissions by July 2010. The agency says it will “most likely occur in a phased in approach” and is expected to be fully implemented by July 1, 2010. There is a new version of the STED guidance document in the works and it is expected to be released for industry comment in the fall of 2009 – just a few months away. We’ll keep you posted as we learn more.

MHRA publishes updated guidance document for clinicals conducted in UK

In July, the MHRA issued an updated guidance document on clinical investigations to be carried out in the UK. It’s an update on previously available guidance that takes into account the impact of 2007/47/EC, the revision to the directives which takes effect in March 2010. One of the major updates in this document is the confirmation that it will be much more difficult to obtain regulatory approval using only clinical literature and that more products will require a clinical investigation. In addition the guidance talks about how to complete an application, outlines how it will be processed and what documentation will be required. You can download the document here.

Redesigned US FDA website an improvement

The US FDA recently launched a new website, with a new look and organization. It is certainly better than the old site, but it still could use some improvement in the way information for consumers versus industry is presented. In any case, check out the medical devices section of the new FDA site for yourself . Also see the revised section with FDA Guidance Documents. k3jt6excvi

European Commission issues important guidance document on 2007/47/EC

The EU has just released an important guidance document that should be read by every company selling medical devices in Europe. It provides guidance on an amendment to the original Medical Devices and Active Implantable Medical Devices Directives. Probably the most important part of the 2007/47/EC guidance for medical device companies is that the amended directive goes into effect on 21 March 2010 and there will be no transitional period. This means that companies must comply by March 21. There are other points you should read about as well. You can download the entire 2007/47/EC guidance document and read our analysis of the changes made by 2007/47/EC to 93/42/EEC on our website.

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