Everything You always Wanted to Know About the Medical Device Amendments andWeren't Afraid to Ask. Third Edition

摘要

The purpose of the booklet is to provide the interested reader with anintroduction to medical devices and with answers to questions frequently asked about device regulation. Many guidance documents have also been issued to complement these regulations. The answers to a few of the questions in the booklet may change with future policy decisions. Therefore, the booklet should not be viewed as established policy, binding on the Agency. Rather, it is an attempt to clearly portray current views of CDRH officials to provide general guidance for individuals and firms wishing to comply with the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Act. Contents: Articles Subject to the Medical Device Amendments of 1976; Classification of Devices; General Controls; Performance Standards; Premarket Approval; Exemption of Devices for Investigational Use; Custom Devices; Preemption of State and Local Requirements; Inspections Relating to Devices; Trade Secrets and Confidential Information; Traceability; Assistance for Small Manufacturers of Devices; Import and Export of Devices; Color Additives for Devices; Medical Device Reporting.