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
Regulatory Affairs | Chris Schorre June 25, 2009 |
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.
Tags: 2007/47/EC, 93/42/EEC
Regulatory Affairs | Chris Schorre June 11, 2009 |
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.
Tags: FDA
Regulatory Affairs | Chris Schorre May 8, 2009 |
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
Tags: FDA
Regulatory Affairs | Chris Schorre May 1, 2009 |
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.
Tags: FDA
Regulatory Affairs | Chris Schorre April 9, 2009 |
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.
Regulatory Affairs | Chris Schorre March 19, 2009 |
Effective April 1, 2009 manufacturers of electrical medical devices and manufacturers of electrical components that are to be sold into the Province of Ontario are required to register with the Ontario Electrical Safety Authority. Companies will have from April 1 to August 30, 2009 to comply with this new registration requirement. You can read more about Ontario’s electrical safety requirements on the Electrical Safety Authority website.
Regulatory Affairs | Chris Schorre March 13, 2009 |
A lot of people know that the US Department of Commerce publishes short research reports on the medical device industry in specific countries, but it’s worth repeating in case you have not visited in some time. You can read regulatory process overviews on 20+ countries at the DOC website. If you want to read the actual regulations for a specific countries, we have many of them posted in our Learning Library on our website.
Tags: DOC, regulations
In case you missed our newsletter on the topic, Evangeline Loh, our VP of Regulatory Affairs, provided some information on new European clinical data guidance documents released late last year. If you manufacture or sell stents, you’ll definitely want to read it but the information is useful to all medical device manufacturers.
Tags: MEDDEV
Regulatory Affairs | Chris Schorre March 3, 2009 |
In 2007 the European Commission released MEDDEV 2.14/3 REV 1 which opened the door for IVD companies with professional use products to place their Instructions for Use (IFU) online instead of placing multilingual paper inserts inside product packaging. That could be a huge cost savings to some IVD companies but one key requirement makes it difficult for IVD companies to take advantage of elabeling. The MEDDEV stipulates that companies must provide a toll-free number in every European country where the product is sold. That’s a big challenge since there is no real pan-European toll-free phone number. However, we thought that you might be interested in knowing that one of our partners offers a reasonably priced elabeling service for IVD companies.
Regulatory Affairs | Chris Schorre February 18, 2009 |