PUBLICATIONS - Medical Devices - Obtaining FDA Market Clearance:
This article was originally published in Clinica
Executive Summary
Medical Devices: Obtaining FDA Market Clearance is a comprehensive reference on the US regulatory clearance process by Jonathan Kahan, a partner at lawyers Hogan & Hartson. Drawing on the experience of the firm's medical device practices group, the book contains detailed analyses of key statutory and regulatory device reforms of the 1990s. Priced at $275 (plus shipping and handling), it is available from Parexel International, 195 West Street, Waltham, MA 02154, US. Tel: +1 (617) 487 9900. Fax: +1 (617) 466 8497; or Jonathan Kahan, Hogan & Hartson, Columbia Square, 555 Thirteenth Street, NW, Washington, DC 20004-1109, US. Tel: +1 (202) 637 5600. Fax: +1 (202) 637 5910.