Attachment C - Data Item Description (REFERENCE ONLY)

DATA ITEM DESCRIPTION

Title: RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS REGULATED

BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA)

Number: DI-TCSP-82040
AMSC Number: 9651
DTIC Applicable: Yes
Preparing Activity: MD3

Approval Date: 20160503
Limitation: n/a
GIDEP Applicable: n/a
Project Number: TCSP-2016-001

Applicable Forms: All forms required to be completed by the contractor in preparation of the data product are identified below.
Use/relationship: This Data Item Description (DID) is published by the U.S Army Medical Research & Materiel Command (USAMRMC) to facilitate the acquisition of technical data to support the research and development of drugs, biologics, medical devices, or some component thereof regulated by the U.S. Food and Drug Administration (FDA). This DID contains the format, content, and intended use information for the data deliverable resulting from the work task described in the solicitation.
Requirements: See table of contents and description of the requirements below.

Source: https://assist.dla.mil -- Downloaded: 2026-07-17T19:15Z Check the source to verify that this is the current version before use.

DI-TCSP-82040

1. Administration

2. Drugs and Biologics

a. Product Development Planning Documents
(1)
Regulatory Strategy
(2)
Regulatory Development Plan
(3)
Pre-clinical Development Plan
(4)
Clinical Development Plan
(5)
Manufacturing Development Plan
b. FDA Interactions
(1)
Meetings
(2)
Communications
(3)
Submission Packets
(4)
Inspections and Enforcement
(5)
Registration and Listing
c. Pre-clinical Testing and Trials
d. Clinical Trials
e. Manufacturing
f. Quality Assurance
(1)
Quality Agreements
(2)
Quality Management Plan

3. Medical Devices

a. Product Development Planning Documents
(1)
Regulatory Strategy
(2)
Regulatory Development Plan
(3)
Pre-clinical Development Plan
(4)
Clinical Development Plan
(5)
Manufacturing Development Plan
b. FDA Interactions
(1)
Meetings
(2)
Communications
(3)
Submission Packets
(4)
Inspections and Enforcement
(5)
Registration and Listing
(6)
Post-marketing Commitments
(7)
Clinical Laboratory Improvement Amendments (CLIA) Waivers and supporting documentation
c. Pre-clinical Testing and Trials
d. Clinical Trials
e. Manufacturing
Source: https://assist.dla.mil -- Downloaded: 2026-07-17T19:15Z Check the source to verify that this is the current version before use.