FDA Regulatory Forum 2016

September 14th in Cleveland, Ohio

Each year BioOhio teams up with Laura Green, LLC, representatives from the FDA, and industry experts to bring you a program focused on regulatory issues pertinent to Ohio’s medical products industry. This year’s event will focus on topics such as ISO 13485, management of suppliers & contractors, purchasing controls, CAPA, medical device single audit program, FDA inspections, 510(k), new FDA guidance documents, and clinical trials for medical devices and drugs.

The day features presentations by FDA and industry experts, as well as panel discussions for you to ask the experts your unanswered regulatory questions. The event facilitates great industry and professional networking in addition to the valuable content.

The FDA Regulatory Forum is consistently one of our most popular and well attended events.

This event is made possible by generous sponsorship of companies and organizations that value the power of partnerships and networking. Click here to learn more about sponsoring this event.


8:15 am- 8:45:  Registration, Networking, Breakfast

8:45 – 9:00:  Introductions, Opening Remarks

9:00 – 12:00:  Morning Session

What is changing with ISO 13485:2016?

The new revision places a greater emphasis on the QMS throughout the supply chain and product lifecycle, a Risk-Based Quality System, as well as device usability and post-market surveillance requirements. Examine the requirements of ISO 13485:2016, the major changes and the 3-year transition plan.

Management of Suppliers & Contractors – Risk-Based Approach

  • Presented by Dan Debrah, Director of Global Supplier Quality, Hill-Rom

Outsourced materials and services represent a significant and critical part of most medical device companies.  In an industry where it is becoming more challenging to maintain compliance, ensure product quality, and control cost, it is critical to establish a Purchasing Controls Program that minimizes risk within your supply chain but is also sustainable.  This presentation will provide guidance on how to design such a Purchasing Controls Program utilizing a risk-based approach.

Purchasing Controls

A Risk-Based CAPA Process

“Death by CAPA” – Does this sound like your CAPA process? Does every problem result in a CAPA, causing late CAPAs or those that simply do not get resourced?  This presentation will provide some practical guidance and tools for incorporating Risk-based criteria into your CAPA process and satisfy FDA’s expectations for risk-based CAPAs.

Medical Device Single Audit Program (MDSAP)

MDSAP is an international initiative led by Regulatory Authorities (RA) to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer that would be accepted by multiple regulators to address ISO, QMS/GMP requirements. Understand what will happen at the end of the pilot in December, 2016. What is the impact on industry and medical device certifications?  Discuss critical dates and planning considerations for companies who currently or plan on marketing in Canada.

12:00 – 12:45 pm:  Lunch

12:45 – 4:15:  Afternoon Session

FDA Inspection Issues and Expectations

510(k) Process

  • Presented by Marjorie Shulman, Director, Premarket Notification [510(k)] Program, FDA

A discussion on FDA 510(k) trends and submission issues.

New FDA Guidance Documents for Medical Devices

The FDA has been more active than ever in publishing new guidance documents to help industry understand FDA’s thinking on product and policy topics.  This presentation will discuss interpretation and implementation of recent FDA Final Guidance documents:

  • General Wellness: Policy for Low-Risk Devices
  • Applying Human Factors and Usability Engineering to Medical Devices.

An overview of proposed draft guidance documents:

  • Use of Real-World Evidence to Support Regulatory Decision Making for Medical Devices
  • Deciding When to Submit a 510(k)s for Changes to Existing Devices (modifications and software)

Clinical Trials for Medical Devices and Drugs: When Do You Need Them and What Are the Cost Drivers

When do I need human clinical trials for my product?  For drug products, the simple answer is always. For medical device products, the need for human trials is driven by FDA guidelines and regulations.  However, there are other reasons that are not so obvious for running human clinical trials for medical device products.  Once a company has committed to running human clinical trials, there are several questions that then arise:  What are the cost drivers for a clinical trial?  Why are they the cost drivers?  How do these cost drivers differ between a Phase III oncology drug study and a 510K study for a dental medical device?  What are the options for saving money in the conduct of a clinical trial?  This talk will address the answers to all of these questions and others concerning the clinical trial process.

4:15 – 4:20:  Wrap-Up

4:20 – 5:00:  Networking Reception

In partnership with


Sponsored by





Hosted by



Hosted by Thompson Hine

127 Public Square #3900

Cleveland, OH 44114

This event is a part of the [M]EDNEXT series. Presented by MAGNET, in partnership with BioOhio, [M]EDNEXT is a program designed to connect established manufacturing companies to critical biomedical knowledge and resources that will help them diversify their revenue streams by entering the growing medical manufacturing industry to create jobs and strengthen the local and state economy. The series is sponsored by JPMorgan Chase. Learn more about this series here.

Complimentary registration is available for auto or aerospace suppliers interested in becoming a medical device supplier. Contact jgoldsberry@bioohio.com for the discount code.