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  1. Inspection References

Field Management Directives

The FDA’s Field Management Directives (FMD) are public-facing directives regarding the management of Office of Regulatory Affairs (ORA) field activities that fall outside the scope of other manuals or procedural documents.  They were originally intended to communicate field policy information from headquarters to the field. The scope was later broadened to include both policy and process information. The directives continue to provide field managers with instructions on the management of field activities in both program and operational areas. The first manual providing guidance to field staff was implemented in 1970 and titled Field Policy Directives. By the end of 1972, the manual's title was changed to Field Management Directives. FMDs are issued on the authority of the Associate Commissioner for Regulatory Affairs (ACRA) and approved by an Assistant Commissioner in ORA.

All Current Field Management Directives

NUMBER SUBJECT AREA FMD DATE WEB POSTING DATE STATUS
13 International Travel Operations Management 03/16/09   Revised
13 Att. A Memo - Justification for Late Submission of International Travel Operations Management 11/01/02   Revised
13 Att. B Memo - Justification for Two or More Travelers Operations Management 11/01/02   Revised
13 Att. C Model Letter of Invitation Operations Management 11/01/02   Revised
13 Att. D Model Letter of Acceptance Operations Management 11/01/02   Revised
13 Att. E General Information about FDA Employee Who Attend, Participate in or Speak at Non-Federal Meetings, Conferences, and Symposiums Operations Management 11/01/02   Revised
13 Att. F Sponsor Certification Operations Management 11/01/02   Revised
13A Foreign Inspection Program Operations Management 10/05/10   Revised
13A Att. A Request for Nomination to the FDA International Inspection Cadre Operations Management 03/16/09   Revised
13A Att. B Criteria Required for Nomination to the FDA International Inspection Cadre Operations Management 03/16/09   Revised
15 Product Shortage Communication Operations Management 07/31/12 09/24/12 New
29 Implementing the FDA/National Oceanic & Atmospheric Administration (NOAA) MOU - FMD#-029 DACRA 10/31/11   New
30 ORA Program Committee Operations Management 01/05/10   Revised
30A ORA/CFSAN Human Food Program Committee Office of Human and Animal Food Operations (OHAFO) 08/31/2020 09/012020 New
30B ORA/CVM Animal Food Program Committee Office of Human and Animal Food Operations (OHAFO) 08/31/2020 09/01/2020 New
37 ORA Procedures for Responding to Foreign Visitor or Information Requests Operations Management 03/25/10   Revised
50 State Correspondence State Program Management 05/02/11   Revised
56 ORA Weekly Management Review Operations Management 04/05/10   Revised
76 State Contracts-Evaluation of Inspectional Performance State Program Management 08/22/2023   Revised
86 Establishment Inspection Report Conclusions and Decisions Operations Management 12/14/2022 12/14/2022 Revised
127 Employee Requested Transfers Operations Management 01/04/13   Revised
134 Pesticide Coordination Teams Operations Management 06/30/94   Revised
135 Pre-operational Reviews of Manufacturing Facilities Operations Management 11/13/09   Revised
137 Badge Retirement Policy Operations Management 04/01/17 03/28/17 Revised
145 Procedure for Release of Establishment Inspection Report to the Inspected Establishment Operations Management 07/31/19 08/26/19 Revised
147 Communicating Laboratory Analytical Findings for Food Products and Environmental Samples Directive Human and Animal Food Operations and Office of Regulatory Sciences 05/04/2020 05/11/2020 Revised
149 Procedures for Requesting ORA International Technical Assistance or Site Visits Operations Management 03/25/10   Original
152 Produce Safety Dispute Mitigation and Resolution Procedures Operations Management 01/31/19 02/04/19 Original
DIR-000088 Investigations of Facilities engaged in the Manufacturing, Packaging, Labeling, and Testing of Medical Products that may be subject to an Emergency Use Authorization (EUA)

Office of Medical Products and Tobacco Operations (OMPTO)

 03/17/21 03/25/21 New

 

 

 

 



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