August 18th, 2014

Secrets to Success: Pre-Subs, 510(k)s, and FDB

Wednesday, September 10, 2014

You are Invited to an Evening Meeting

Secrets to Success
Pre-Subs, 510(k)s, and FDB  


What you need to know to write and submit successful Pre-Submissions and 510(k)s and how to be a compliant medical device manufacturer within the State of CA.

Orange County Regulatory Affairs Discussion Group (OCRA) 


Wednesday, September 10, 2014

5:30 – 8:45 pm 


HORIBA Medical 

9755 Research Drive, Irvine, CA  92618

Program Host: 

Azita Hedayati, MS, CMQ/OE, CQA, Director, Regulatory & Compliance HORIBA Medical 


Program Manager and Moderator:

Kim Walker, MS, RAC (US & EU), Global RA & QA Consultant
Kim Walker Consulting


Harlan Loui, Medical Device Safety Section Chief, State of CA, Public Health Department, Food and Drug Branch

Deborah Morris, Senior Director, Clinical, Myraqa, Inc.

Barb Stevens, RAC, Regulatory Consultant


The 510(k) program has been a hot topic lately and the FDA has implemented improvements to the review process. Many companies (large and small) struggle with creating comprehensive submissions that minimize FDA questions and, conversely, delays to market entry. Come learn how Pre-Submissions can improve your 510(k) clearance times, the basics of 510(k) submissions, hear good submission practices from 510(k) proficient professionals, and learn about the recent changes to the Pre-Submission and 510(k) FDA review processes.


Additionally, many California-based companies do not know that the State of CA requires medical device manufacturers to obtain Medical Device Manufacturing Licenses prior to conducting validation studies using human samples or subjects and prior to placing a device on the market. During this program, you will hear directly from the State of CA Food and Drug Branch about the regulation governing medical devices in the State of CA, inspection requirements or opt-out options, and the new online export certificate application process.

Please join us for these learning opportunities and open discussions with seasoned industry professionals and regulators.




No on-site or walk-in registrations will be accepted for this program.

Space is limited at this facility and registrations will be accepted on a first-come-first-serve basis.



Schedule of Presentations:

5:30 – 6:00 pm           
Registration, Networking, and Refreshments


6:00 – 6:45 pm
FDB Updates and Discussion on New Online Export Certificate Application Process

Harlan Loui, Medical Device Safety Section Chief, State of CA, Public Health Department Food and Drug Branch


6:45 – 7:30 pm
Pre-Submission Program and Best Practices

Deborah Morris, Senior Director, Clinical, Myraqa, Inc.


7:30 – 8:15 pm             

510(k) FDA Review Process and Submission Best Practices

Barb Stevens, RAC, Regulatory Consultant


8:15 – 8:45 pm                         

Panel Discussion, Speaker Q&A, and Closing Remarks



OCRA Members: $50

Non Members: $100 (includes OCRA Membership for one year)

Government and Students: $25

FREE for HORIBA Employees (please email Azita to be added to the list)



Registration fee includes light dinner, beverages and parking.


After the meeting, electronic access to the presentations will be made for all attendees.  


Dress code is business casual.



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