# Presentation: 725678

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

**Bill 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”*
**Section 15 of the SMDA of 1990 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.*

## Who We Are

- DSMICA is a small Division, within the Office of Communication, Education and Radiation Programs (OCER)
- Currently 20 employees:
- Science background
- International Relations specialist
- Consumer communications specialists
- Radiological health specialist
- Latex devices specialist
- Former FDA investigators, ODE reviewers and other specialists.

## What We Do

**Manufacturers Assistance *****(Section 10 MDA)***
**International Assistance *****(Section 15 SMDA)***
**Small Business Determination *****(MDUFMA)***
**Consumer Assistance *****(Pure Food & Drug Act 1906)***
***Inquiries come 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 (cont.)

- We respond to a range of questions and needs that are as broad as the medical device industry, itself!
- We function as the CDRH point person for the implementation of Third Party Programs and assessment of third parties  [AP for 510(k) review, AP for Inspection, and US/EC MRA].
- While founded in the law, our function is based on the belief that education fosters voluntary compliance.

## What We Do (cont.)

- IF we do our jobs well, submissions and compliance are improved.
**	****We work very closely with our colleagues in other Offices.  We especially  DEPEND on ****ODE****, ****OIVD**** and ****OC**** to keep us informed of policy changes.**

## Stakeholder Requests

- 510(k)						22%
- Quality System					16%
- New Company					12%
- Registration/Listing	  			12 %
- Import/Export		  			  9%
- Labeling			  			  8%
- IDE			  			  7%
- PMA			  			  6%
- Inspectional		 			  4%
- Other (e.g. classification/standards)	  4%

## 	Manufacturers Assistance	Premarket guidance

- Device classification
- Registration & Listing
- Premarket Notification & Premarket Approval processes
- User Fees
- Investigational Device Exemptions
- Explanation of laws, regulations &  policies.

## 	Manufacturers Assistance	Postmarket guidance

- Reporting changes in device ownership, company names, etc.
- Reporting adverse events
- Changes to existing devices
- Detentions of imported devices
- Compliance with Q.S.
- Recalls and other corrective actions
- Exporting medical devices

## International Assistance

- CDRH focal point/coordinator for international activities
- Primary interface with the agency’s OIP
- Explanation of device importation requirements
- Participation in international standard setting bodies

## Small Business Determinations

- Applicant that qualifies as a small business ($30 or $100 million or less) eligible for reduced fees
- 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
- 600 – 700 Determinations per year.  Average review time 6 hours per determination.

## Consumer Assistance

- FDA the premier “consumer protection agency”
- Direct response to device related concerns from the public
- Explanation of the duties, responsibilities and authorities of the Center

## Goals of DSMICA

**Provide regulatory assistance and participate in educational programs to improve industry compliance**
**Support International Activities:**
**U.S. -  EC MRA**
**GHTF Study Groups**
**Government to Government Assistance**
**Respond to requests for Small Business Designation in a timely manner**
**Provide medical device information to consumers to assist in their health related decisions**

## 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 2005 (rounded to nearest 1,000)
- Domestic industry contacts = 50,000
- International contacts = 7,000
- Consumer contacts = 7,000
- Our Device Advice website, alone, had >134,000 “hits”
- We distributed 83,000 hard copy 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
- Impact Resistant Lens Guide
- Medical Glove Guidance Manual

## 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

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## 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
**Small Business Determination Phone**:  301-443-0806 ext. 115
**Consumer Phone**: 301-827-3990 or Fax: 301-443-9535
**Email Address**: **dsmica@fda.hhs.gov**

## Questions?