ETLS 721 Medical Device – Regulatory Submissions

Course Description

Class Outline

About the Instructor

E-Mail Instructor

Grad Engineering Home

Instructor:

Bob Klepinski

Time:

Section 01, Monday, 6:00 – 9:00 p.m.

Location:

St. Paul Campus, OWS 251

Telephone:

612 492 7336 (Office)

rklepinski@fredlaw.com

Required

Text:

• Class Handouts
• References to be provided

Suggested Readings:

• Familiarity with FDA Website (http://www.fda.gov/default.htm)
• Familiarity with Code of Federal Regulations Title 21 (http://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfcfr/cfrsearch.cfm)

Course Description:

This course teaches the student about submissions for regulatory approval of medical devices.  Topics include: medical device law, custom and research devices, significant and nonsignificant risk devices, FDA investigational device exemption, 510(k) substantial equivalence determination, pre-market approval (PMA), PMA supplements, combination devices, European economic area CE mark, international harmonization, MDR, device tracking, post market surveillance, annual post approval reporting, and the basics of reimbursement for medical devices. 

Course Objectives:

To provide insights into the key elements of contemporary medical device regulatory affairs including:

1.    US Food Drug and Cosmetic Act and its medical device amendments

2.    US Code of Federal regulations: 21 CFR Parts 50 and 56 Part 800

3.    Requirements and methodology for clinical and marketing applications to notified bodies and regulating authorities in the USA and Europe

4.    Essential understanding FDA non-quality system related enforcement practices.

5.    Overview of US reimbursement practice

Learning Outcomes:

Course Methodology:

The instructor will serve as a facilitator and lecturer, with expert guest speakers on many topics. Extensive group participation is expected. Outside readings are assigned and are expected to be maintained on schedule, regardless of their inclusion in the following class’s discussion.

Major
Assignments:

Assignments:

Two Take-home mid course exam: (T)   20 points each

Closed Book Final Exam                           40 points

Class Attendance & Participation: (CP)   20 points

                                                               100 points

Grading Policy:

Tests and papers must be completed on time.  Effective class participation is essential.

    100-95 A
      94-92 A-
      91-89 B+
      88-86 B
      85-83 B-
      82-80 C

See also:  Term Paper Evaluation Criteria

Academic Integrity:

All students are expected to understand and follow the University of St Thomas policies on Academic Integrity. These are described at: http://www.stthomas.edu/engineering/graduate/policies

Exams:

Exams are one of the instruments used to evaluate the knowledge gained by an individual student of the class subject matter, and the progress towards meeting the outcomes of the class and the degree.  To this end all exams (in class or take home) are intended to represent the effort of the individual and not a group effort unless specifically stated otherwise.

Attendance
Policy:

Students are expected to attend all class sessions. Circumstances which prevent attendance will be honored up to two instances. Absences in excess of two times may result in a lower grade for the course. Contact the instructor when a special situation arises. All absences require that the instructor be informed in advance.

Students with Disabilities

Qualified students with documented disabilities who may need classroom accommodations should make an appointment with the Enhancement Program – Disability Services office during the first two weeks of the semester.  Appointments can be made by calling 651-962-6315 or in person in O’Shaughnessy Educational Center, room 119.

Instructor Background:

Robert Klepinski is an Officer with Fredrikson & Byron and practices in the Food and Drug Administration, Health Care Fraud & Compliance and Intellectual Property service areas. Robert is also recognized as one of the leading FDA compliance attorneys. Prior to joining the firm, Robert counseled pharmaceutical, medical device, biotech, food and nutritional supplement companies on FDA policy. Robert was a regulatory attorney for Medtronic, Inc., the world's leading medical technology company specializing in implantable and invasive therapies. While at Medtronic, he set the legal strategy for FDA compliance, including advertising and promotion, quality systems, regulatory and clinical.

Robert frequently speaks at both local and national trade associations on FDA policy. He has been a guest lecturer at law schools, including University of Minnesota, Northwestern, Hamline University and William Mitchell. He is currently an adjunct professor at St. Thomas University in their mini MBA program.

Education

·                   William Mitchell College of Law, J.D., 1980, cum laude

·                   University of Minnesota, B.A., Mathematics, English

Bar Admissions

·                   Minnesota, 1980

·                   United States Patent Office

Professional Activities

·                   Minnesota State Bar Association, Founder, Food and Drug Law Section

·                   University of St. Thomas Adjunct Professor

·                   Medical Alley, Co-Chair, Regulatory Special Interest Group

·                   Regulatory Affairs Professional Society

·                   Food and Drug Law Institute, Editorial Board

Community Involvement

·                   AFDO Endowment Foundation, Board Member

ETLS 721-01

Medical Device – Regulatory Submissions

Spring 2008

Class / Date

Topics

Assignments