cpdguy
11-22-2006, 06:05 AM
I would suggest downloading this document. The topic from time to time comes up on tracking of various products. This document contains some changes. It could have an impact on your practice.
REVISED GUIDANCE REQUIRES DEVICE TRACKING ONLY WITH FDA ORDER
The FDA has revised industry guidance on device tracking, noting that manufacturers are not required to track devices unless the agency has issued them an order to do so.
The tracking provisions of the Federal Food, Drug and Cosmetic Act had previously called for mandatory tracking of certain devices, even if the FDA had not ordered it. In 1993 the agency provided a guidance listing the devices it felt should be tracked, such as permanently implanted devices and life-supporting devices used outside facilities such as nursing homes or hospitals.
The updated tracking guidance was issued concurrently with guidance on FDA recommendations on premarket approval applications for breast implants.
The guidances were issued as the agency announced its approval of silicone gel-filled breast implants, which were pulled from the market in 1992 due to safety concerns.
The device tracking guidance can be viewed at www.fda.gov/cdrh/comp/guidance/169.pdf.
The silicone gel implant guidance can be viewed at www.fda.gov/cdrh/ode/guidance/1239.html.
REVISED GUIDANCE REQUIRES DEVICE TRACKING ONLY WITH FDA ORDER
The FDA has revised industry guidance on device tracking, noting that manufacturers are not required to track devices unless the agency has issued them an order to do so.
The tracking provisions of the Federal Food, Drug and Cosmetic Act had previously called for mandatory tracking of certain devices, even if the FDA had not ordered it. In 1993 the agency provided a guidance listing the devices it felt should be tracked, such as permanently implanted devices and life-supporting devices used outside facilities such as nursing homes or hospitals.
The updated tracking guidance was issued concurrently with guidance on FDA recommendations on premarket approval applications for breast implants.
The guidances were issued as the agency announced its approval of silicone gel-filled breast implants, which were pulled from the market in 1992 due to safety concerns.
The device tracking guidance can be viewed at www.fda.gov/cdrh/comp/guidance/169.pdf.
The silicone gel implant guidance can be viewed at www.fda.gov/cdrh/ode/guidance/1239.html.