Page 244 - Assurance of Sterility for Sensitive Combination Products and Materials

CHAPTER 9

Regulatory pathway for labeling

combination products as sterile ☆

b
a
Trabue D. Bryans , Eamonn Victor Hoxey , Steven Turtil c
a BryKor, LLC, Marietta, GA, United States
b E V Hoxey Ltd, Cirencester, United Kingdom
c U.S. Food and Drug Administration/CDRH, Silver Spring, MD, United States
Contents
9.1 Labeling products as sterile 222
9.1.1 Communicating with regulatory authorities 222
9.2 Seeking FDA feedback 223
9.2.1 Additional points to consider 224
9.3 EU submission process 225
9.3.1 Regulatory classification 225
9.3.2 Marketing authorization as a medical product 226
9.3.3 CE-marking for a medical device 227
9.4 FDA guidance on labeling devices as sterile 228
9.4.1 Methods of sterilization 229
9.4.2 Content recommendations for 510(k)s 230
9.5 Documents pertaining to terminal sterilization and SAL 231
9.5.1 Guidance from the Association for the Advancement of Medical
Instrumentation 231
9.5.2 European standards for terminal sterilization 232
9.5.3 New guidance from ISO 233
9.5.4 Documents pertaining to aseptic processing and assurance of sterility 234
9.5.5 ISO 13408 series 234
9.5.6 EN 556-2 235
9.5.7 Evaluation of medicinal products 235
9.6 Summary 236
Further reading 236

☆ The sections of this chapter entitled “Seeking FDA feedback” and “FDA guidance on la-
beling devices as sterile” have been authored by Steven Turtil. They reflect the views of the
author and should not be construed to represent FDA’s views or policies.

Assurance of Sterility for Sensitive Combination Products and Materials © 2020 Elsevier Inc.
https://doi.org/10.1016/B978-0-12-805082-8.00009-8 All rights reserved. 221