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Zdrowie i gospodarka · 10/07/1997

FDA Denies Petition to Reclassify Ostomy Pouch and Accessories

The FDA has rejected a request by Abraham L. Lastnik to move the ostomy pouch and accessories from Class I to Class II classification, citing a lack of new scientific evidence to support the claim that current safety and effectiveness controls are insufficient.

Source: Federal Register — Food and Drug AdministrationOpen original release →