SonoSite is comprised of an innovative team of professionals with many years of experience in medical diagnostic ultrasound technology. SonoSite is at the forefront of defining a world-class standard of quality management for ultrasound manufacturing. FUJIFILM SonoSite, Inc. is an FDA registered firm as a specification developer and manufacturer of medical devices.
SonoSite products are designed, manufactured, and distributed in full accordance with the requirements of FDA’s Quality System Regulation. We are regularly inspected by our European notified body under the medical device directive. Regulatory documents for both individual devices and SonoSite’s quality management system are available upon request.
REGULATORY AFFAIRS CONTACT
Sr. Director, Regulatory Affairs and Quality Assurance
For Regulatory Affairs general information requests, please click here.
UNITED STATES/ CANADA
The 510(k) pre-market notification process is the most common method used in the United States for describing the design and manufacture of medical devices which the US Food and Drug Administration (FDA) uses to determine a "substantial equivalence" decision to authorize marketing of a medical device within the United States.
The Canadian regulatory process for determining safety and effectiveness of medical devices is managed by Health Canada’s Therapeutic Products Directorate.
US FDA 510(k) database where copies of 510(k) substantial equivalence decisions along with SonoSite summaries of safety and effectiveness.
Health Canada Medical Devices Active License Listing database for each product listed.
To place a medical device on the market within the European Union, CE marking of the device is required and the manufacturer must comply with European Union Medical Device Directive (MDD) - Council Directive 93/42/EEC of 14 June 1993 concerning medical products as amended by 2007/47/EC. SonoSite maintains technical documentation files (TDF) on each device covered by CE marking. The TDF is made available to the notified body or national authorities for Conformity Assessments according to MDD 93/42/EEC Annex II, MDD 93/42/EEC Annex V or MDD 93/42/EEC Annex IX.
For each SonoSite device marketed within the European Union SonoSite prepares a declaration of conformity with the MDD and applies CE marking. For other countries, outside of the European Union, additional documentation is available.
To request a copy of the product's Declaration of Conformity Certificate, please click here.
ALL OTHER COUNTRIES
For marketing authorization applications to the regulatory authorities in a particular country, relevant technical details concerning SonoSite devices can be supplied upon request. This technical information is formatted in the style used within the European Union.
In addition, the US FDA provides export certificates, known as Certificates to Foreign Government (CFG) that certify a particular device may be marketed in, and legally exported from the United States of America and that the manufacturing plants in which the device is produced is subject to periodic inspections and that the last inspection showed that the plant appeared to be in substantial compliance with good manufacturing practice requirements.
To request a copy of the product's Certificate to Foreign Government, please click here.