# Presentation: 725677

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

**William M. Sutton**
**Deputy Director**

## Why DSMICA?

- Section 10 of the “Medical Device Amendments of 1976” required:
- “an identifiable office to provide technical and other nonfinancial assistance to small manufacturers of medical devices”

## Who We Are

- DSMICA is a small Division, within the Office of Health and Industry Programs
- Currently 24 employees
- Science background
- Radiological health specialist
- Latex devices specialist
- Former FDA investigators, ODE reviewers and other oddities including a Pharmacist.
- Consumer communications specialists

## What We Do

**Manufacturers Assistance**
**International Assistance**
**Consumer Assistance**
**Radiological Devices**
- We respond to inquiries from an extremely broad audience: device manufacturers, distributors, inventors, device users, buying agents, import brokers, attorneys, academicians, patients, the general public and students.

## What We Do - 2

- We respond to a range of questions and needs that are as broad as the medical device industry, itself!
- While founded in the law, our function is based on the belief that education fosters voluntary compliance.

## What We Do - 3

- IF we do our jobs well, there is less need for inquiries to ODE, OIVD, and OC
**We work very closely with our colleagues in other Offices.  We are DEPENDENT on ****YOU**** to keep us informed of policy changes.**

## Manufacturers AssistancePremarket guidance

- Assistance with device classification
- Assistance with Registration & Listing
- Explanation of the Premarket Notification & Premarket Approval processes
- Explanation of User Fees
- Investigational device guidance
- Explanation of laws, regulations &  policies.

## Manufacturers AssistancePostmarket guidance

- Guidance for reporting changes in device ownership, company names, etc.
- Guidance regarding reporting adverse events
- Guidance regarding changes to existing devices
- Guidance regarding detentions of imported devices.
- Guidance regarding legal actions
- Guidance regarding recalls and other corrective actions
- Assistance for exporting medical devices

## International Assistance

- Assistance to foreign device firms to assure the safety & effectiveness of devices coming to our ports of entry
- Assistance to foreign governments
- Explanation of our laws, regulations, policies and procedures
- Cooperation in many areas including adverse event reporting
- Sharing of important information

## International Assistance

- Participation in the Global Harmonization Task Force (GHTF)
- Explanation of device importation requirements
- Participation in international standard setting bodies

## Consumer Assistance

- Direct response to inquiries from the public
- Home of the FDA’s breast implant consumer expert
- Explanation of the duties, responsibilities and authorities of the Center

## Goals of DSMICA

- Provide regulatory assistance and develop educational programs for Industry
- Support International Activities:
- U.S. -  EC MRA
- GHTF Study Groups
- Government to Government Assistance
- Provide medical device information to consumers

## Assistance Programs

**Telephone/Email/Fax**
**Educational Programs**
-  Web Pages
- Guidance Development
- Presentations/Exhibits
**Support CDRH Programs**
- Guidance Distribution
- Mailings/Broadcast Faxing/510(k) Status

## Telephone/Fax/Email

- Automated Document Fax Back System
- Toll-Free Number
**Phone: 800-638-2041 or 301-443-6597**
**Fax: ****	****301-443-8818**
**Email: dsmica@cdrh.fda.gov**
- Medical Device Specialists
**Monday - Friday 8:00 a.m. to 4:30 p.m. EST**

## A Volume Business

- In FY 2003 (rounded to nearest 1,000)
- Domestic industry contacts = 50,000
- International contacts = 6,000
- Consumer contacts = 6,000
- Our Device Advice website, alone, had >108,000 “hits”
- We distributed 110,000 documents

## Guidance Development

- Write plain language “How To” guidance to help industry comply with regulatory requirements.
- Examples:
- Premarket Notification 510(k)
- Quality Systems/GMP Manual
- Medical Device Reporting
- Medical Glove Guidance Manual

## Guidance Distribution

**Over 1,000 Publications**
**FY02 - 38,000**
**World Wide Web**
**FY02 - 1,027,000**

## DSMICA Web Pages

**Device Advice**:
- www.fda.gov/cdrh/devadvice
**Third Party**:
- www.fda.gov/cdrh/thirdparty
**International Homepage**:
- www.fda.gov/cdrh/international
**U.S./EC MRA Homepage**:
- www.fda.gov/cdrh/mra
**Consumer Homepage**:
- www.fda.gov/cdrh/consumer/index.html

## DSMICA Page 

- www.fda.gov/cdrh/industry/support/
- Contents
- Contact Information
- Resources, e.g. Device Advice
- CDRH Initiatives, e.g. Third Party
- Documents/Manuals
- Workshop Calendar
- Over 4,500 accesses per month

## Device Advice

- Self-service site for medical device and radiation emitting electronic product information
- Is my product a medical device?
- What is the device classification?
- How to market your device?
- www.fda.gov/cdrh/devadvice
- Recently updated, MDUFMA

## Slide 21

## Slide 22

## DSMICA Contact Information

- Industry Phone: 800-638-2041 or              301-443-6597 or Fax: 301-443-8818
- International Phone: 301-443-6597 or  Fax: 301-443-8818
- Consumer Phone: 301-827-3990 or     Fax: 301-443-9535
- Email Address: **dsmica@cdrh.fda.gov**