Update Feb, 99"Medical Device Inspection
Evaluation"
Pilot Customer Satisfaction Survey
In a January 28, 1999, Federal Register Announcement, the FDA announced a one year
pilot of a customer satisfaction survey entitled "Medical Device Inspection
Evaluation."
The purpose of the evaluation is to provide a means whereby the medical device industry
can provide feedback in an anonymous way to the FDA's Office of Regulatory Affairs (ORA)
regarding the medical device inspectional process. ORA intends to utilize a third party to
collect the evaluations and trend the data submitted.
This program is supposed to go into effect on March 1, 1999 through February 28, 2000
and anyone can send in written comments on the program to the FDA during this time.
The preprinted forms with the name of the firm and the investigator's name will be left
at the firm for completion and will be set in a preaddressed supplied envelope to UCI
Center of Statistical Consulting where the information will tabulated.
This program was as a result of the Medical Device Initiative Grassroots Taskforce
which included both the industry and the FDA.
For a copy of the form please contact mdi's office or the FDA using Docket No.
99N-0053.
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