Don F. Palme II, Ph.D., Sr Principal Product Development Strategist, Medical Research Scientist, Regulatory, NAMSA. His opinion is as follows:
Based on the wording and examples provided, Use of the Markman Surfacing Device does not change the risk or material, formulation or chemical composition of the materials. Based on this analysis, the changes induced by the Markman Surfacing Device does not reach the level of change considered a major change to the device so resubmission of the device should not be required. A letter to the device file describing the change(s) and justification of regulatory position should address the regulatory requirements.
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