ASTM F1441-03 (Reapproved 2014)

Standard Organization:

ASTM F1441-03 (Reapproved 2014)
Standard Specification for Soft-Tissue Expander Devices

• Recognition Date: 2015-08-14
• Recognition List: 040
• Recognition Number: 6-110
• Extent: Complete standard
• Standards Orgs: ASTM ASTM International http://www.astm.org/
• STG: General Plastic Surgery/General Hospital
• FDA Tech: David Kraus FDA/OMPT/CDRH/ODE/DSD 301-796-6970 david.kraus@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

1.1 This specification covers the requirements for single use saline inflatable, smooth and textured tissue expansion devices to be used intraoperatively or implanted for typically less than 6 months and then removed.

1.2 Limitations:

1.2.1 This specification applies only to soft-tissue expander devices fabricated with elastomer shells. It does not necessarily cover any custom fabricated soft tissue expander device manufactured to any other specification.

1.2.2 This specification applies, in part, to combination "expander/mammary" devices as classified in Section 4.

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
Unclassified	Expander, Skin, Inflatable		LCJ

FDA Guidance:

There is no relevant guidance developed at this time.