Description
This document provides current specifications for submitting individual case safety reports (ICSRs) and ICSR attachments in electronic form. The specifications apply to electronic submission of ICSRs for drug and biological products, studied under an investigational new drug application (IND); ICSRs from bioavailability/bioequivalence (BA/BE) studies conducted without an IND, and ICSRs for marketed drug and biological products and combination products to the FDA Adverse Event Reporting System (FAERS). The specifications do not apply to the following marketed biological products: prophylactic vaccines, whole blood or components of whole blood, human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated by FDA.
Scope & Applicability
Product Classes
4Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Drugs not FDA-approved undergoing lower regulatory standards
Excluded from the scope of this document
Human cells, tissues, or cellular or tissue-based products defined in 21 CFR Part 1271
Stakeholders
5Entity responsible for submitting applications under section 524B
Entity submitting development data and knowledge; Entity performing the work process for change
Responsible for qualifications, training, and trial conduct; Individual responsible for trial conduct and data governance at a site.; May delegate tasks but retains overall responsibility; Person responsible for the conduct of the clinical trial at a trial site; Responsible for trial conduct and participant safety; Responsible for trial conduct, data integrity, and investigational product management.; Individual responsible for trial conduct at a site and informing the institution.; maintaining
Person operating the device
Entity responsible for submitting NDINs
Regulatory Context
Attributes
10Electronic transport format headers
Data element B.4.k.2.2
Data element B.4.k.2.1
Suspect product assessment
Local criteria for expedited reporting
Reporting timeframe for expedited safety reports
Indicate whether the device constituent part was labeled for single use
Date the device was manufactured
Date of device explant from the patient
Date of device implant in the patient
Identified Hazards
Hazards
1The type of reportable event covered under the VMSR program
Related CFR Sections (5)
- 21CFR310.305§ 310.305 Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
(a) Scope. FDA is requiring manufacturers, packers, and distributors of marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application to establish and maintain records and make reports to FDA of all serious, unexpected adverse drug experiencRead full regulation →
- 21CFR600.80§ 600.80 Postmarketing reporting of adverse experiences.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR314.80§ 314.80 Postmarketing reporting of adverse drug experiences.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR312.32§ 312.32 IND safety reporting.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR4.101§ 4.101 How does the FDA define key terms and phrases in this subpart?
Abbreviated new drug application (ANDA) has the same meaning given the term “abbreviated application” in § 314.3(b) of this chapter .Read full regulation →
Related Warning Letters (10)
- 2025-11-25
Compounding Pharmacy/Adulterated Drug Products
Wells Pharma of Houston, LLC
- 2025-05-13
Compounding Pharmacy/Adulterated Drug Products
Tailstorm Health Inc. dba Medivant Health
- 2025-03-25
Compounding Pharmacy/Adulterated Drug Products
Annovex Pharma, Inc.
- 2025-03-04
Compounding Pharmacy/Adulterated Drug Products
ProRx, LLC
- 2024-10-22
Compounding Pharmacy/Adulterated Drug Products
Stokes Healthcare Inc. dba Epicur Pharma
- 2023-08-08
Compounding Pharmacy/Adulterated Drug Products
US Specialty Formulations, LLC
- 2022-01-18
Compounding Pharmacy/Adulterated Drug Products
Apothecary Health Solutions/Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop
- 2021-10-26
Compounding Pharmacy/Adulterated Drug Products
Empower Clinic Services, LLC dba Empower Pharmacy
- 2021-08-31
Compounding Pharmacy/Adulterated Drug Products
AnazaoHealth Corporation
- 2021-08-03
Compounding Pharmacy/Adulterated Drug Products
Farmakeio Outsourcing LLC
See Also (8)
- Electronic Submission of IND Safety Reports Technical Conformance Guide : Guidance for Industry (Status: Final)
- Providing Submissions in Electronic Format — Postmarketing Safety Reports (Status: Final)
- Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies: Draft Guidance for Industry (Status: Draft)
- Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic (Status: Final)
- Postmarketing Safety Reporting for Combination Products: Guidance for Industry and FDA Staff (Status: Final)
- Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Status: Final)
- Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines: Guidance for Industry (Status: Final)
- Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies: Guidance for Industry and Investigators (Status: Final)