Issue Date: 03/15/1995
Issued By: Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of Device Evaluation
This guidance was written prior to the February 27, 1997 implementation of FDA's Good Guidance Practices, GGP's. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be up dated in the next revision to include the standard elemnt s of GGP 's .
Guidance on Premarket Notification 510(k) Submission for Short-Term Long-Tern Intravascular Catheters reflects a perceived need to address complications associated with this device. Manufacturing technology and clinical expertise have evolved such that commercially available catheters (and their associated labeling) may no longer adequately reflect the current expectation for safe and effective application.