FDA Proposes Change to Device Labels: Symbols Without Text

FDA has recently proposed allowing primary labels on medical devices to have symbols without accompanying English text.  For medical devices sold in Europe, for example, primary labels can have symbols without any textual explanation adjacent to the symbol on the device primary label (per ISO 15223-1:2012, “Symbolsto be used with medical device labels, labeling and information to be supplied-Part 1: General requirements).  Examples of such symbols are shown below:

[Photo - http://www.leone.it/english/quality/product-symbols.php]

The proposed changes would affect medical devices, biologics, and in vitro diagnostics as regulated by 21 CFR Parts 660, 801, and 809, and would allow certain symbols to “stand alone” on primary labeling so long as a glossary with symbol explanation accompanies the product - think in the Instructions for Use document. 

RAPS.Org

A well known professional society in the biotech regulatory space is the Regulatory Affairs Professional Society or RAPS (link to home page: www.raps.org).

An excerpt from their "About" page:

The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices in Europe and Asia, and chapters and affiliates worldwide.

Medical Device News: Stay Informed

After putting out any fires that arise overnight, the first thing I do every morning for work is browse the email  news briefs and various medical device/regulatory websites.  A range of topics strike my interest including product approvals, industry mergers and acquisitions, recalls, company lawsuits and settlements, and newly proposed or published guidance documents and legislation.

It's taken me a few years to understand just where I like to poke around every morning, and depending on the daily news, I tend to hold a non-standard routine according to content of the first headlines of interest.  Some days I jump right to industry publications and news sources to get the whole picture of a recent company acquisition - think when a large medical device company announces the purchase of a smaller company.  Other days I dig into the bowels of the FDA website for as much public information I can find about a recently approved or recalled product, curious about its approval path and timeline to market.  My favorite mornings are those when a new or draft guidance document pertaining to some relevant issue is released by FDA as this usually leads me down the path of dredging up the existing guidance on the matter or mapping out how the new information can or will affect the products with which I'm working.

But where to get started?  Which news briefs and websites do I frequent?  How can one better stay abreast medical device industry noteworthy happenings?  Here are a few resources to consider during your breakfast browsing sessions: