OCRA’s eNEWSLETTER            September 2004

 

Message from the Editor

 

I wanted to thank those of you who offered us their comments and suggestions on the first OCRA eNEWSLETTER that was distributed last month.  All comments will be considered for subsequent newsletters in an effort to maximize the value of this benefit to OCRA members.

 

Thanks,

 

Paul Kramsky 

 

Message from the OCRA President

 

Hello OCRA Members,

 

As we enter the “back to school” season, OCRA’s focus should be clear to all 611 members…education, education, education.  Even though we are all very busy and find it tough to devote time to educational opportunities (or allow members of our staff to attend), we as Regulatory Affairs Professionals need to continue to support the exchange of information, promote collaboration within the industry and with regulatory bodies, and educate each other with the vast knowledge we have in the areas of devices, pharmaceuticals, IVDs, and biologics.    Through educational opportunities provided by OCRA, we hope to better equip all members. If there are topics that members would like to be covered in future meetings, please continue to provide suggestions and volunteers are always welcome!  Remember to also visit the website for current information…www.ocra-dg.org.

 

Barbara Niksch

 

 Congratulations to Rusty Lusk!

 

OCRA's own Rusty Lusk, Programs Chair on the OCRA Board of Director's, will receive a RAPS Special Recognition Award for Local Outreach and Networking at this year's RAPS annual meeting. This award is designed to recognize innovative and effective efforts to increase professional awareness and involvement in local areas or regions. OCRA would like to thank Rusty for his commitment to bringing quality programs to our members and helping our members become RAC certified. Please help us congratulate Rusty on this well deserved award.

 

 Update on Programs

 

We are having a great year with Programs and the next few months are no exception. For instance, the following sessions are coming up before the end of the year:

August - Part 11 program was a great success -- more than 100 attendees!

August 30 -- Regulatory Ethics - Everything you need or want to know.

October 6th - Mexico & South American Regulatory Environment, it's changing and you don't want to be caught off-guard.

November 16 - World-Wide Clinical Requirements (and we do mean World-wide). Imagine one- clinical protocol supports all your regulatory submissions. It can be done.  Come and find out how.

The Program Committee is already mapping 2005 and the sessions are taking great shape. Stay tuned for more information and visit our website to keep current. Additionally, if you have any topics you would like us to consider, please email Rusty Lusk (me) at qualitysys@sbcglobal.net. With your help and ideas, we can keep the programs going and help us all stay informed.

 

Bringing Medical Devices to Market

 

 

King & Spalding's FDA Practice Group is presenting a one-day conference on navigating regulatory issues and the challenges of bringing new medical devices to market.  This conference, entitled Bringing Medical Devices to Market, will be held on Tuesday, October 5, 2004 at the Hilton Costa Mesa, Costa Mesa, California from 8:30 am – 5:30 pm PDT.  A special discount is being offered for OCRA members -- $100.00 off the regular registration fee of $249.00.  Topics include 510(k)s, IDEs, PMAs, combination products, FDA enforcement activities, as well as advertising and promotion. Get the scoop on recent FDA regulations, and the most effective go-to-market strategies from former FDA employees and longtime counselors.  For details on this conference, please go to the King & Spalding flyer on OCRA’s website.

 

CDRH News

 

Medical Device Advertising

There are currently no plans in place by CDRH to reinstate a separate division to handle medical device advertising enforcement.  The former Promotion and Advertising Policy Staff (PAPS), the group responsible for monitoring medical device promotion, had merged with the Office of Compliance (OC) in spring 2003, in an effort to adopt a more product-focused approach within the OC.  While the likelihood of reconstituting PAPS is probably remote but still envisioned as a possibility, according to Timothy Ulatowski, Director of the OC, Ulatowski maintains that CDRH is dedicated to medical device advertising enforcement.  They are working on a website that would feature advertising-related Warning Letters and Untitled Letters issued to medical device companies.  Stay tuned!

 

Medical Device User Fees

Look for important information on Medical Device User Fee Rates for 2005 at http://www.fda.gov/cdrh/mdufma/fy2005summary.html.

 

Are You Planning to take an RAC Examination in November?

                                                                                           

The registration deadline for the November 6 certification examinations is September 15, 2004. Visit the RAPS website at www.RAPS.org for additional information. OCRA has assisted our members by providing study groups for either the US RAC or the EU RAC examinations. If you are interested in participating in a study group for these exams, please e-mail OCRA's Administrator, Kimberly Syre, at ksyre@cox.net.

 

Advance your regulatory education!

 

If you are interested in expanding your regulatory knowledge and advancing your education and credentials in this burgeoning profession, you may want to take a look at USC Master's of Science Regulatory Science Program.  Detailed information on this program, including the Fall 2004 schedule, may be found by going to http://regulatory.usc.edu/schedule.cfm.

 

OCRA MDR Network

 

The next meeting of the OCRA MDR Network will be September 22nd at 4 pm.  The meeting will be held at Alcon Labs on Alton Parkway.  Julie Taylor will be our speaker - and will discuss the complaint requirements as related to service reports.  This is an important complaint issue that medical device equipment companies must decide when managing service calls.

 

There is no charge to attend the OCRA MDR Network Meetings.  We try to meet once a month - but the meetings do vary.  We have just completed a 4-part meeting series, "Complaint Handling - Back to Basics".  The MDR Network is a great opportunity to discuss the regulations and share experiences with others in the field.  If you would like to be added to the MDR Network meeting notification list, please contact Chris Posin at christineposin@msn.com.

 

New MedWatch 3500A Form mandatory

 

For those who manage MDR responsibilities, please remember that August 17, 2004 was the cutoff date for using the old 3500A form.  The new 3500A MedWatch form should now be used.  This form includes changes in Section D to cover the use of reprocessed devices.  This form may be obtained at http://www.fda.gov/medwatch/safety/3500a.pdf.   If you would like a form that you can complete on your PC, the form may be obtained at http://www.fda.gov/medwatch/SAFETY/FDA3500A_fillable.pdf.  You must have the full version of Adobe Acrobat to use the fillable form (not the free version).

 

FDA-OCRA 2005 Educational Conference

 

We are already working on the 2005 annual conference.  If you have ideas on topics that you would like to see on the meeting agenda, please send them to christineposin@msn.com.  We will do our best to select topics that are interesting to all who attend.