Business · 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.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →