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

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

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

44 Evolution of DSMICA 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 – MDUFMA I (Section 738) –established a fee reduction for small business; fee waiver and fee reduction regarding premarket approval fees and premarket notification fees.

55 Who is DSMICA 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.

66 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 e- mails and letters to CDRH Stakeholders; Belief: education fosters voluntary compliance.

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

88 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.

99 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.

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)

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.

External Training Modules Device Advice CDRH Learn 12

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 gulationandGuidance

CDRH Learn 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. 14

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 dGuidance/GuidanceDocuments/ucm htmhttp:// dGuidance/GuidanceDocuments/ucm htm 15

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

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