Field Management Directives

The FDA’s Field Management Directives (FMD) are public-facing directives regarding the management of Office of Inspections and Investigations (OII) 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 Inspections and Investigations (ACII) and approved by an Assistant Commissioner in OII.

All Current Field Management Directives

NUMBER	SUBJECT	AREA	FMD DATE	WEB POSTING DATE	STATUS
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
56	ORA Weekly Management Review	Operations Management	04/05/10		Revised
134	Pesticide Coordination Teams	Operations Management	06/30/94		Revised
135	Pre-operational Reviews of Manufacturing Facilities	Operations Management	11/13/09		Revised
145	Procedure for Release of Establishment Inspection Report to the Inspected Establishment	Operations Management	07/31/19	08/26/19	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