1. FDA Resources and Meetings
FDA/EMA Orphan Designation and Grant Workshop
Silver Spring, Maryland
FDA Campus (White Oak)
October 12, 2012
Bill Sutton
Deputy Director
Division of Small Manufacturers, International and Consumer Assistance
Office of Communication and Education
Center for Devices and Radiological Health
U.S. Food and Drug Administration

2. Agenda
Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
Device Advice
CDRH Learn
Presubmission Program

3. Division of Small Manufacturers, International and Consumer Assistance (DSMICA)

4. Evolution of DSMICA 1976 - Medical Device Amendments (Section 10)
mandated "an identifiable office to provide technical and other nonfinancial assistance to small manufacturers of medical devices”
1990 – SMDA (Section 15)
established an office of international relations to participate in meetings and enter into agreements with foreign countries to facilitate commerce in devices between the U.S. and such countries.
2002 – MDUFMA I (Section 738)
established a fee reduction for small business; fee waiver and fee reduction regarding premarket approval fees and premarket notification fees. 4 4

5. Who is DSMICA 21 employees:
in Office of Communication, Education and Radiation Programs (OCER)
21 employees:
Division Director, Mr. Elias Mallis
Science Background
International Relations specialists
Consumer communications specialists
Former FDA investigators, ODE reviewers, QS specialists, Industry and Medical Professionals. 5 5

6. What We Do
Respond to a range of questions and needs that are as broad as the medical device industry, itself!
Serve as CDRH point person for the implementation of the Third Party Programs;
Communicate important safety notices via s and letters to CDRH Stakeholders;
Belief: education fosters voluntary compliance. 6 6

7. Major Program Areas industry assistance (premarket)
industry assistance (postmarket)
small business determination (SBD)
consumer assistance
international program
Center notifications
industry education/training modules 7 7

8. Industry Assistance - pre-market
Device classification
Electronic Registration & Listing
Premarket Notification & Premarket Approval processes
Quality Systems (Design Controls)
User Fees
Investigational Device Exemptions
Explanation of laws (FDAAA), regulations & policies. 8 8

9. Industry Assistance – postmarket
Quality Systems
Reporting adverse events
Changes to existing devices
Detentions of imported devices
Recalls and other corrective actions
Exporting medical devices
Reporting changes in device ownership, company names, etc. 9 9

10. Small Business Determinations (SBDs)
Applicant that qualifies as a small business is eligible for reduced fees ($100 million or less / $30 million or less - first PMA free)
Applicant must qualify as a small business at least 60 days before their first submission in a fiscal year
Small Business status expires at the end of the fiscal year
1400 Determinations per year (20% from Foreign Firms) 10 10

11. Consumer Assistance FDA the premier “consumer protection agency”.
Direct response to medical device and radiation-emitting product related concerns from the public.
Explanation of the duties, responsibilities and authorities of CDRH. 11 11

12. External Training Modules
Device Advice
CDRH Learn

13. Device Advice
Self-service site for medical device and radiation-emitting electronic product information
Is my product a medical device?
What is device classification?
How to market your device?
Postmarket Requirements
Import/Export 13 13

14. CDRH Learn www.fda.gov/cdrh/cdrhlearn
Newest Online Resource for Industry Education
Categories of Modules:
Overview of Regulatory Requirements: Medical Devices
Quality System Regulation 21 CFR Part 820 Basic Introduction
Device Establishment Registration and Listing
Overview of the Premarket Notification Process – 510(k)
How to Get Your Electronic Product on the U.S. Market
Bioresearch Monitoring (BIMO) [very prolific area]
Interagency Agreement (IAG) with U.S. State Department to translate all modules into Chinese (Mandarin) and Spanish.
Certificate Available for each Topic upon Successful Completion of a Post Test.

15. The Pre-Submission Program and Meetings with FDA Staff
July 13, 2012 – Draft Guidance issued.
Purpose is to provide feedback to applicant on all submission types, including HDEs.
Pre-Sub Package
Pre-Sub Meeting with CDRH

16. Telephone/Fax/
Toll-Free Number
Phone: or
Fax:
Medical Device Specialists
Monday - Friday 8:00 a.m. to 5:00 p.m. EST 16 16

17. www.fda.gov/Medical Devices
Questions?
Devices