Medical device development : regulation and law /

Title:

Medical device development : regulation and law /

Author:

Kahan, Jonathan S., author.

Format:

Book

Institution:

MCPHS Boston

Contents:

The framework for regulation of medical devices -- The 510(k) premarket notification process -- Device modifications requiring a 510(k) notice -- FDA regulation of medical device software -- The investigational device exemption application : overview of the IDE process and humanitarian devices -- Medical device clinical studies -- The premarket approval application -- Review of a premarket approval application -- PMA supplements -- Medical device reclassification -- The regulation of in vitro diagnostics -- The quality system regulation -- Compliance -- Medical device exports and imports -- Product jurisdiction and the regulation of combination products -- Working well with FDA.

Online access:

No online access

Library holdings:

MCPHS Circulation - Boston Campus
KF3827.M4 K34 2014 – Available

• Available Temporarily at MCPHS Reserve Desk - Boston Campus
  On reserve for DRA817 Devel. & Prod. of Med. Devices (DRA (Regulatory Affairs & Health Policy): Sands)
  On reserve for DRA817 Devel. & Prod. of Med. Devices (DRA (Regulatory Affairs & Health Policy): Morello)