------------------------------------------------------------------------

Contents (.PDF)                   Federal Register

Contents (.TXT)                   Vol. 63, No. 215

                                               Friday, November 6, 1998

------------------------------------------------------------------------

Food and Drug Administration

Some of these documents may also contain internal hyperlinks to other documents

RULES

Mutual Recognition of Pharmaceutical Good Manufacturing Practice Inspection Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports Between the United States and the European Community. Pages 60121-60164 [FR Doc. 98-29609] (OC 98181, Docket No. 98N-0185) [TEXT] [PDF]

PROPOSED RULES

General Hospital and Personal Use Devices: Proposed Classification of Liquid Chemical Sterilants and General Purpose Disinfectants. Pages 59917-59921 [FR Doc. 98-29566] (CDRH 9757, Docket No. 98N-0786) [TEXT] [PDF]

NOTICES

Memorandum of Understanding Between the Food and Drug Administration and The Office of the United States Trade Representative. Pages 60165-60166 [FR Doc. 98-29608] (OC 98269) [TEXT] [PDF]

GUIDANCE

Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry; Availability. Pages 60009-60010 [FR Doc. 98-29750] (CDRH 98111, Docket No. 98D-0924) [TEXT] [PDF]

This is the guidance

Guidances for the Medical Device Industry on PMA Shell Development and Modular Review; Availability. Pages 60010-60011 [FR Doc. 98-29752] (CDRH 9878, Docket No. 98D-0896) [TEXT] [PDF]

This is the guidance