Home | Online Resources | UB Catalog | Campus Libraries | About UB Libraries | Forms | Search | Help

Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health

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

[image: man working at computer and talking on a telephone]

Why DSMICA?

The Division of Small Manufacturers, International and Consumer Assistance (DSMICA) was mandated by the 1976 medical device legislation to provide technical and regulatory assistance to small manufacturers to help them comply with Food and Drug Administration (FDA) requirements for medical devices. Promulgation of the Safe Medical Devices Act of 1990 and the FDA Modernization Act of 1997 expanded DSMICA's role in providing assistance.

Manufacturers Assistance Staff

Representing the needs and interest of the small manufacturers is a basic function of DSMICA.

• We identify ways in which FDA requirements can be developed so they are neither unfair nor unduly burdensome to small business.
• We encourage participation by small firms in the regulatory process itself, especially at the early stage when comments are sought on proposals that will have impact on the device industry.
• We educate CDRH staff on medical device manufacturer's needs and problems with meeting FDA's regulatory requirements.

We Develop Guidance

DSMICA develops and makes available electronically a wide variety of "How To" guidance to help industry comply with regulatory requirements. Examples include premarket notification [510(k)], premarket approval (PMA), investigational device exemptions (IDE), GMP/ QS, Registration and Listing. For new medical device companies, DSMICA provides a "general marketing package" that contains information on the basic FDA requirements for marketing a medical device in the United States (U.S.)

We Participate at Regulatory Conferences

DSMICA staff routinely participates at workshops, symposiums, seminars, and conferences speaking on medical device and radiological health regulations. For the current schedule of workshops with CDRH participation, please visit: www.fda.gov/edrh/dsma/

We Administer the 510(k) Status Request Program

Applicants may request information on the status of their 510(k) review 60 days after the initial log-in date of the 510(k). To obtain a 510(k) review status, the applicant should complete a status request form, which is available at: http://www.fda.gov/cdrh/dsma/858.html DSMICA responds within 3 working days.

We Administer the Accredited Persons Program for the Review of 510(k)s by Third Parties

The purpose of the program is to improve the efficiency and timeliness of the 510(k) process. FDA has accredited 12 organizations to conduct 510(k) reviews for selected class I and II devices. The average 510(k) reviewed by an Accredited Person received clearance by FDA 29% faster. For more information on the Accredited Persons Program visit: www.fda.gov/cdrh/thirdparty/

International Affairs Staff

CDRH's International Affairs Staff identifies and supports global harmonization activities, implementation of the U.S./EC Mutual Recognition Agreement (MRA), educates foreign governments on the U.S. medical device regulatory process, and directs U.S. firms to sources of information on foreign requirements for medical devices. For more information visit: www.fda.gov/cdrh/internationalissues.html

Consumer Staff

CDRH's Consumer Staff provides information to consumers regarding medical devices and radiation-emitting products so they can make informed decisions about the risks and benefits of such products. For more information visit: www.fda.gov/cdrh/consumer/index.shtml

Obtaining Information on the Web

Manufacturers and others who are interested in the regulatory requirements for marketing medical devices and radiation-emitting electronic products can quickly obtain the latest information on policies and procedures through the CDRH website at: www.fda.gov/cdrh, including:

• Information on CDRH programs, the latest medical device regulations. and how to sign up to receive daily E-mails of new items posted to the CDRH web site.
• Device Advice, a CDRH self-service site for medical device and radiation-emitting product information. Device Advice is a step-by-step system for obtaining information concerning medical device requirements and is available at: www.fda.gov/cdrh/devadvice
• Guidance documents are prepared for CDRH Staff, Regulated Industry, and the public. You can search the Good Guidance Practices (GGP) database at: www.fda.gov/cdrhl guidance.html
• Overview of Electronic Radiation Control Laws and Regulations. For a listing of electronic products and associated performance standards, please visit: www.fda.gov/cdrh/radhlthlindex.html

Contacting DSMICA

Division of Small Manufacturers, International and Consumer Assistance
Office of Health and Industry Programs
Center for Devices and Radiological Health

Top of page