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.
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.
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.
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.
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.
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.
We recently did a study of our medical device and IVD clients and asked them how they use their mobile phones. Of the 260+ people who responded, about 27% said they currently use their mobile phone to access information online. That was higher than we had expected. Another 43% said they do not use their phone for internet searches, but do use it for emailing or texting. About 30% only use their phones for calls.
The research is interesting because it shows that companies serving the medical device industry need to develop mobile phone friendly websites. Just trying accessing your own website using your mobile phone and see if it is user friendly on your screen. I know we’ll be doing some work on this soon!
As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That’s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you’ll enjoy the content.
Regulatory Affairs | Chris Schorre, Emergo Group April 9, 2009 | 