FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 004. (15NOV00)
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Guidance for Industry and for FDA Reviewers: Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997; Availability. (09AUG00)
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The Guidance

Report to Congress on Pediatric Exclusivity; Request for Comments.  (05MAY00)
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DOCKET , OC00, "Agency Information Collection Activities; Announcement of OMB Approval; Reporting and Recordkeeping Requirements for Manufacturers, Importers, User Facilities, and Distributors of Medical Devices Under FDAMA. (13APR00)
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Supporting Statement

Guidance for Industry on Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act; Availability. (30MAR00)
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The Guidance

Agency Information Collection Activities; Submission for OMB Review; Comment Request; Reporting and Recordkeeping Requirements for Manufacturers, Importers, User Facilities, and Distributors of Medical Devices Under FDAMA.  (26JAN00)
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FDA Modernization Act of 1997; Guidance on Medical Device Tracking; Availability. (24JAN00)
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The Guidance