Zdrowie i gospodarka · 12.02.2003
Medical Device Warning Letter Pilot Termination
The Food and Drug Administration (FDA) is announcing the termination of the Medical Device Warning Letter Pilot (MDWLP). This pilot concerns the issuance of warning letters for quality system, premarket notification (510(k)), and labeling violations. The intent is to inform the medical device industry of FDA's decision to discontinue this pilot program.