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82 FDA section As a topic for this column, I have been invited to comment on FDA satisfaction with the degree of regulatory compliance demonstrated by in- vestigators in the intraocular lens clinical investi- gation. The extensive monitoring activities made necessary by the unprecedented size of this study have disclosed a few minor irregularities in the records of some investigators visited by our field personnel. The vast majority of these deficiencies however have been administrative in nature and were satisfactorily resolved following discussion with the investigator and/or the study sponsor. I would also like to add that, as of the first ten months of the study, no investigators have been disqualified by sponsors or by the FDA-a fact which we feel proves the excellent regulatory compliance exhibited by study investigators. I n short then, the FDA is satisfied with investigator compliance. In fact, we encourage AIOIS members and other investigators to main- tain their high standard of performance. It is our hope that the very admirable record achieved in the investigation's first months will serve as a benchmark for the continuation of this study, and for all subsequent medical device investigations. Best wishes for a prosperous and success- ful 1979. Max W. Talbott, Ph . D. Executive Secretary Ophthalmic Device Classification Section Bureau of Medical Devices Editor's Note: Dr. Talbott has expressed willingness to respond in this column to specific questions on clinical study protocol and other issues of general interest pertinent to the FDA's involvement with intraocular lenses. Your questions or comments should be addressed to Dr . Max W. Talbott, c/o AIOISJ, P. O. Box 3140, Santa Monica, CA 90403. AM INTRA-OCULAR IMPLANT SOC J-VOL. V. JANUARY 1979

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Page 1: FDA section

82

FDA section

As a topic for this column, I have been invited to comment on FDA satisfaction with the degree of regulatory compliance demonstrated by in­vestigators in the intraocular lens clinical investi­gation. The extensive monitoring activities made necessary by the unprecedented size of this study have disclosed a few minor irregularities in the records of some investigators visited by our field personnel. The vast majority of these deficiencies however have been administrative in nature and were satisfactorily resolved following discussion with the investigator and/or the study sponsor. I would also like to add that, as of the first ten months of the study, no investigators have been disqualified by sponsors or by the FDA-a fact which we feel proves the excellent regulatory compliance exhibited by study investigators.

I n short then, the FDA is satisfied with investigator compliance. In fact , we encourage AIOIS members and other investigators to main­tain their high standard of performance. It is our hope that the very admirable record achieved in the investigation's first months will serve as a benchmark for the continuation of this study, and for all subsequent medical device investigations.

Best wishes for a prosperous and success­ful 1979.

Max W. Talbott, Ph.D. Executive Secretary Ophthalmic Device Classification Section Bureau of Medical Devices

Editor's Note:

Dr. Talbott has expressed willingness to respond in this column to specific questions on clinical study protocol and other issues of general interest pertinent to the FDA's involvement with intraocular lenses. Your questions or comments should be addressed to Dr. Max W. Talbott, c/o AIOISJ, P.O. Box 3140, Santa Monica, CA 90403.

AM INTRA-OCULAR IMPLANT SOC J-VOL. V. JANUARY 1979

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