Agenda

9:00–10:30 am

Device Classification, Strategy and Presubmission Research
Candice Burns, RAC manager, regulatory affairs, Boston Scientific Inc.
Marjorie Shulman, acting director, premarket notification (510(k)) section, ODE, CDRH, FDA

• Determining device classification and submission type
• Recent 510(k) updates
• Insight into presubmission strategy development, including classification and pre-Investigational Device Exemptions (IDEs)
• Development of 510(k) and PMA submission strategies

10:45 am–12:00 pm

Presubmission Meetings and Communications With the US Food and Drug Administration (FDA) for 510(k)s, IDEs and Premarket Approval Applications (PMAs)
Laura Byrd, MS, PMA staff, ODE, CDRH, FDA
Lynn Henley, MS, MBA, IDE staff, ODE, CDRH, FDA
Angela Krueger, regulatory advisor and CDRH Product Jurisdictional Officer, ODE, CDRH, FDA
Sharon Timberlake, MS, RAC, CCRA, director, regulatory affairs, Palomar Medical & Technology Inc.

• Pre-IDE meetings—what they mean
• Communicating: When and with whom
• Do’s and Don’ts of interacting with FDA—processes and tips

1:00–2:15 pm

Premarket Notification Background, Substantial Equivalence and Techniques for Identifying Predicates for 510(ks)s
Jeffrey Shapiro, JD, director, Hyman, Phelps & McNamara, P.C.
Marjorie Shulman, acting director, premarket notification (510(k)) section, ODE, CDRH, FDA

• Legal background of 510(k) and substantial equivalence
• Techniques for identifying predicates
• Relationships between quality systems and design control benefiting 510(k)

2:30–3:30 pm

Best Practices and Useful Tips for 510(k)s, IDEs and PMAs
Candice Burns, RAC manager, regulatory affairs, Boston Scientific Inc.
Lynn Henley, MS, MBA, IDE staff, ODE, CDRH, FDA

An interactive dialogue geared toward troubleshooting and avoiding common mistakes, including:

• Data collection outside the US
• The reviewer’s viewpoint: what are the most common issues reviewers identify
• Guidance on how to construct a 510(k)

3:30–4:30 pm

Addressing Combination Products
Candice Burns, RAC manager, regulatory affairs, Boston Scientific Inc.
Angela Krueger, regulatory advisor and CDRH Product Jurisdictional Officer, ODE, FDA

9:00–10:30 am

What Regulatory Ought to Know About Clinical Investigations & Inspections
Matthew Tarosky, PharmD, EJD, CCRP, deputy director, Division of Bioresearch Monitoring, Office of Compliance FDA
Sharon Timberlake, MS, RAC, CCRA, director, regulatory affairs, Palomar Medical & Technology Inc.

• Reasonable assurance of safety and effectiveness
• Good Clinical Practice
• Bioresearch Monitoring inspections

10:45–11:30 am

Postmarket: Event Reporting, Supplements and More
Eugene Reilly, public health analyst, Office of Surveillance and Biometrics, CDRH, FDA
Sharon Timberlake, MS, RAC, CCRA, director, regulatory affairs, Palomar Medical & Technology Inc.

• Understand postmarketing requirements for medical device reports (MDRs)
• Periodic reports, supplements, and product changes
• Complaint handling procedures and investigation processes
• eMDR; industry experience; lessons learned

11:30 am–12:30 pm

Advertising & Labeling
Jeffrey Shapiro, JD, director, Hyman, Phelps & McNamara, P.C.

1:30–3:00 pm

Compliance
David Kalins, consumer safety officer, special assistant to the director, Office of Compliance, CDRH, FDA

• How to prepare and file establishment registrations and device listings with FDA
• Examining Quality System Regulation (QSR), current Good Manufacturing Practices (CGMPs) for medical devices and medical device manufacturer inspections
• Staying on top of corrections and removals (recalls) and medical device tracking
• US requirements for exporting devices

3:15–4:30 pm

Final Review—Device Jeopardy

8:30–10:30 am

e-submissions and eSubmitter: An overview
Antoinette Azevedo, president, e-SubmissionsSolutions.com
Julie “Brandi” Stuart, branch chief, Information Analysis Branch, Office of Surveillance and Biometrics, CDRH, FDA

• Paper or electronic? – 510(k) submissions to OIVD

10:45–11:30 am

Managing for Success: Issues Regarding the Content of an Electronic Submission
Antoinette Azevedo, president, e-SubmissionsSolutions.com

11:30 am–12:30 pm

Best Practices in Use of MS Word and Adobe Acrobat Professional

Antoinette Azevedo, president, e-SubmissionsSolutions.com