ABSTRACT
Hematology Kits And Packages; Hematology And Pathology Devices A, FACTOR 866.5330 FACTOR XIII, A, S, IMMUNOLOGICAL TEST SYSTEM
Immunological Test Systems; Immunology And Microbiology Devices A, FIBRINOPEPTIDE 866.5350 FIBRINOPEPTIDE A IMMUNOLOGICAL TEST SYSTEM
Immunological Test Systems; Immunology And Microbiology Devices A, IMMUNOGLOBULIN 866.5510 IMMUNOGLOBULINS A, G, M, D, AND E IMMUNOLOGICAL TEST SYSTEM
Immunological Test Systems; Immunology And Microbiology Devices A, VITAMIN 131.127 NONFAT DRY MILK FORTIFIED WITH VITAMINS A AND D
Requirements For Specific Standardized Milk And Cream; Milk And Cream A, VITAMIN 184.1930 VITAMIN A
Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
A, VITAMIN 582.5930 VITAMIN A Nutrients And/or Dietary Supplements; Substances Generally Recognized As Safe
A, VITAMIN 582.5933 VITAMIN A ACETATE Nutrients And/or Dietary Supplements; Substances Generally Recognized As Safe
A, VITAMIN 582.5936 VITAMIN A PALMITATE Nutrients And/or Dietary Supplements; Substances Generally Recognized As Safe
A, VITAMIN 862.1805 VITAMIN A TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices
ABANDONMENT 1303.27 ABANDONMENT OF QUOTA Individual Manufacturing Quotas; Quotas
ABBREVIATED APPLICATION 314.92 DRUG PRODUCTS FOR WHICH ABBREVIATED APPLICATIONS MAY BE SUBMITTED Applications For FDA Approval To Market A New Drug
ABBREVIATED APPLICATION 314.94 CONTENT AND FORMAT OF AN ABBREVIATED APPLICATION Applications For FDA Approval To Market A New Drug
ABBREVIATED APPLICATION 314.96 AMENDMENTS TO AN UNAPPROVED ABBREVIATED APPLICATION Applications For FDA Approval To Market A New Drug
ABBREVIATED APPLICATION 314.97 SUPPLEMENTS AND OTHER CHANGES TO AN APPROVED ABBREVIATED APPLICATION Applications For FDA Approval To Market A New Drug
ABBREVIATED APPLICATION 314.99 OTHER RESPONSIBILITIES OF AN APPLICANT OF AN ABBREVIATED APPLICATION Applications For FDA Approval To Market A New Drug
ABBREVIATED APPLICATION 314.105 APPROVAL OF AN APPLICATION AND AN ABBREVIATED APPLICATION Applications For FDA Approval To Market A New Drug
ABBREVIATED APPLICATION 314.122 SUBMITTING AN ABBREVIATED APPLICATION FOR, OR A 505(J)(2)(C) PETITION Applications For FDA Approval To Market A New Drug
ABBREVIATED APPLICATION 314.150 WITHDRAWAL OF APPROVAL OF AN APPLICATION OR ABBREVIATED APPLICATION Applications For FDA Approval To Market A New Drug
ABBREVIATED APPLICATION 314.152 NOTICE OF WITHDRAWAL OF APPROVAL OF AN APPLICATION OR ABBREVIATED APPLICATION FOR A NEW DRUG Applications For FDA Approval To Market A New Drug
ABBREVIATED APPLICATION 314.430 AVAILABILITY FOR PUBLIC DISCLOSURE OF DATA AND INFORMATION IN AN APPLICATION OR ABBREVIATED APPLICATION Applications For FDA Approval To Market A New Drug
ABBREVIATED APPLlCATIONS 314.100 TIME FRAMES FOR REVIEWING APPLICATIONS AND ABBREVIATED APPLICATIONS Applications For FDA Approval To Market A New Drug
ABBREVIATED APPLlCATIONS 314.440 ADDRESSES FOR APPLlCATIONS AND ABBREVIATED APPLICATIONS Applications For FDA Approval To Market A New Drug
ABBREVIATED NEW DRUG 314.107 EFFECTIVE DATE OF APPROVAL OF A 505(B)(2) APPLICATION OR APPLICATION ABBREVIATED NEW DRUG APPLICATION
Applications For FDA Approval To Market A New Drug ABBREVIATED NEW DRUG 314.127 REFUSAL TO APPROVE AN ABBREVIATED NEW DRUG APPLICATION
APPLICATION Applications For FDA Approval To Market A New Drug ABBREVIATED NEW DRUG 314.151 WITHDRAWAL OF APPROVAL OF AN ABBREVIATED NEW DRUG
APPLICATION APPLICATION UNDER SECTION 505(J)(5) Applications For FDA Approval To Market A New Drug
ABBREVIATED NEW DRUG 314.153 SUSPENSION OF APPROVAL OF AN ABBREVIATED NEW DRUG APPLICATION APPLICATION Applications For FDA Approval To Market A New Drug
ABBREVIATED NEW DRUG 5.106 SUBMISSION OF AND EFFECTIVE APPROVAL DATES FOR ABBREVIATED APPLICATIONS NEW DRUG APPLICATIONS AND CERTAIN NEW DRUG APPLICATIONS
APPLICATIONS NEW ANIMAL DRUG APPLICATIONS AND CERTAIN NEW ANIMAL DRUG
APPLICATIONS Animal Drugs; Redelegations Of Authority; Delegations Of Authority And Organization
ABBREVIATED REPORTS 1002.12 ABBREVIATED REPORTS Required Manufacturers’ Reports For Listed Electronic Products; Records And Reports
ABDUCTION 890.3665 CONGENITAL HIP DISLOCATION ABDUCTION SPLINT Physical Medicine Prosthetic Devices; Physical Medicine Devices
ABDOMINAL 884.5225 ABDOMINAL DECOMPRESSION CHAMBER Obstetrical And Gynecological Therapeutic Devices; Obstetrical And Gynecological Devices
ABNORMAL 864.7415 ABNORMAL HEMOGLOBIN ASSAY Hematology Kits And Packages; Hematology And Pathology Devices
ABORTION 884.5050 METREURYNTER-BALLOON ABORTION SYSTEM Obstetrical And Gynecological Therapeutic Devices; Obstetrical And Gynecological Devices
ABORTION 884.5070 VACUUM ABORTION SYSTEM Obstetrical And Gynecological Therapeutic Devices; Obstetrical And Gynecological Devices
ABRASIVE AGENT 872.6030 ORAL CAVITY ABRASIVE POLISHING AGENT Miscellaneous Devices; Dental Devices
ABRASIVE DEVICE 872.6010 ABRASIVE DEVICE AND ACCESSORIES Miscellaneous Devices; Dental Devices
ABROAD, ENVIRONMENTAL 25.60 ENVIRONMENTAL EFFECTS ABROAD OF MAJOR AGENCY ACTIONS IMPACT Other Requirements; Environmental Impact Considerations
ABSORBABLE 878.4490 ABSORBABLE HEMOSTATIC AGENT AND DRESSING Surgical Devices; General And Plastic Surgery Devices
ABSORBABLE IMPLANT 886.3300 ABSORBABLE IMPLANT (SCLERAL BUCKLING METHOD) Prosthetic Devices; Ophthalmic Devices
ABSORBABLE POWDER 878.4480 ABSORBABLE POWDER FOR LUBRICATING A SURGEON’S GLOVE Surgical Devices; General And Plastic Surgery Devices
ABSORBABLE SUTURE 878.4493 ABSORBABLE POLY(GLYCOLIDE/L-LACTIDE) SURGICAL SUTURE Surgical Devices; General And Plastic Surgery Devices
ABSORBENT 868.5300 CARBON DIOXIDE ABSORBENT Therapeutic Devices; Anesthesiology Devices
ABSORBENT 880.5300 MEDICAL ABSORBENT FIBER General Hospital And Personal Use Therapeutic Devices; General Hospital And Personal Use Devices
ABSORBENT 880.6025 ABSORBENT TIPPED APPLICATOR General Hospital And Personal Use Miscellaneous Devices; General Hospital And Personal Use Devices
ABSORBER 868.5310 CARBON DIOXIDE ABSORBER Therapeutic Devices; Anesthesiology Devices
ABSORBER 872.6050 SALIVA ABSORBER Miscellaneous Devices; Dental Devices
ABSORPTION 862.2850 ATOMIC ABSORPTION SPECTROPHOTOMETER FOR CLINICAL USE Clinical Laboratory Instruments; Clinical Chemistry And Clinical Toxicology Devices
ABUSE, DRUGS OF 809.40 RESTRICTIONS ON THE SALE, DISTRIBUTION, AND USE OF OTC TEST SAMPLE COLLECTION SYSTEMS FOR DRUGS OF ABUSE TESTING Requirements For Manufacturers And Producers; In Vitro Diagnostic Products For Human Use
ABUSE, DRUGS OF 864.3260 OTC TEST SAMPLE COLLECTION SYSTEMS FOR DRUGS OF ABUSE TESTING Pathology Instrumentation And Accessories; Hematology And Pathology Devices
ABUSE, POTENTIAL 314.104 DRUGS WITH POTENTIAL FOR ABUSE FDA Action On Applications; Applications For FDA Approval To Market A New Drug
ACACIA 184.1330 ACACIA (GUM ARABIC) Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe
ACACIA 872.3400 KARAYA AND SODIUM BORATE WITH OR WITHOUT ACACIA DENTURE ADHESIVE Prosthetic Devices; Dental Devices
ACCEPTABLE LEVEL, OZONE 801.415 MAXIMUM ACCEPTABLE LEVEL OF OZONE Special Requirements For Specific Devices; Labeling
ACCEPTANCE 5.606 ACCEPTANCE OF ASSISTANCE FROM STATE AND LOCAL AUTHORITIES FOR ENFORCEMENT OF RADIATION CONTROL LEGISLATION AND REGULATIONS Radiation Control; Redelegations Of Authority; Delegations Of Authority And Organization
ACCEPTANCE 820.80 RECEIVING, IN-PROCESS, AND FINISHED DEVICE ACCEPTANCE Acceptance Activities; Quality System Regulation
APPLICATIONS Registration Of Manufacturers, Distributors, And Dispensers Of Controlled Substances
ACCEPTANCE 1309.34 ACCEPTANCE FOR FILING; DEFECTIVE APPLICATIONS Registration Of Manufacturers, Distributors, Importers And Exporters Of List I Chemicals
ACCESS 20.21 UNIFORM ACCESS TO RECORDS General Policy; Public Information
ACCESS 21.40 PROCEDURES FOR SUBMITTING REQUESTS FOR NOTIFICATION AND ACCESS Procedures For Notification Of And Access To Records In Privacy Act Record Systems; Protection Of Privacy
ACCESS 21.43 ACCESS TO REQUESTED RECORDS Procedures For Notification Of And Access To Records In Privacy Act Record Systems; Protection Of Privacy
ACCESS 21.65 ACCESS TO RECORDS IN EXEMPT SYSTEMS Exemptions; Protection Of Privacy
ACCESS 806.30 FDA ACCESS TO RECORDS Medical Devices; Reports Of Corrections And Removals
ACCESS 876.5540 BLOOD ACCESS DEVICE AND ACCESSORIES Therapeutic Devices; Gastroenterology-urology Devices
ACCESS 1401.4 ACCESS TO INFORMATION Public Availability Of Information
ACCESS 1403.42 RETENTION AND ACCESS REQUIREMENTS FOR RECORDS Reports, Records, Retention, And Enforcement; Uniform Administrative Requirements For Grants And Coop. Agreements To State And Local Gov.
