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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

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Fda resources and meetings

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


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

  • Device Advice

  • CDRH Learn

  • Presubmission Program

Evolution of dsmica
Evolution of DSMICA Assistance

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.



Who is dsmica
Who is DSMICA Assistance

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.



What we do
What We Do Assistance

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 e-mails and letters to CDRH Stakeholders;

Belief: education fosters voluntary compliance.



Major program areas
Major Program Areas Assistance

industry assistance (premarket)

industry assistance (postmarket)

small business determination (SBD)

consumer assistance

international program

Center notifications

industry education/training modules



Industry assistance pre market
Industry Assistance - Assistancepre-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.



Industry assistance postmarket
Industry Assistance – postmarket Assistance

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.



Small business determinations sbds
Small Business Determinations (SBDs) Assistance

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)



Consumer assistance
Consumer Assistance 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.



External training modules
External Training Modules Assistance

  • Device Advice

  • CDRH Learn

Device advice
Device Advice Assistance

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





Cdrh learn www fda gov cdrh cdrhlearn
CDRH Learn Assistancewww.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.

The pre submission program and meetings with fda staff
The Pre-Submission Program and Meetings with FDA Staff Assistance

  • 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

  • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm310375.htm

Telephone fax email
Telephone/Fax/Email Assistance

Email: [email protected]

Toll-Free Number

Phone: 800-638-2041 or 301-796-7100

Fax: 301-847-8149

Medical Device Specialists

Monday - Friday 8:00 a.m. to 5:00 p.m. EST



Questions? Assistance

www.fda.gov/Medical Devices