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Zdrowie i gospodarka · 21.12.1999

Premarket Notification; Requirement for Redacted Version of Substantially-Equivalent Premarket Notification

The Food and Drug Administration (FDA) is proposing to amend its premarket notification regulations to require applicants to submit a redacted version of each premarket notification submission for which FDA has issued an order declaring a device to be substantially equivalent to a legally marketed predicate device. The purpose of this requirement is to provide applicants improved opportunity to protect nonpublic information contained in their premarket notifications while facilitating the release of information to which the public is entitled under the Federal Food, Drug, and Cosmetic Act (the act); the Freedom of Information Act; and FDA's Public Information regulations. The proposed rule does not require submission of a redacted version of any premarket notification received by FDA prior to the effective date of the regulation.

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