Scope & Applicability
Product Classes
1FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices
Stakeholders
10The guidance is specifically prepared for medical device reporting by user facilities.; Entities required to develop written procedures for reporting adverse medical device events; Entities required to notify manufacturers and/or FDA of reportable events.; Entities required to report medical device-related deaths and serious injuries.
A person designated by a facility for FDA correspondence.
Entities required to comply with requirements for imported seafood products
Responses should be generated by medical or scientific personnel
A type of device user facility required to report adverse events
A type of device user facility required to report adverse events
A type of device user facility required to report adverse events
Acute care facility engaged in reprocessing; Entity that may reprocess single-use devices; Entity that may ship devices for reprocessing
A type of device user facility required to report adverse events
Official who may enter an order of default in CMP proceedings; presiding officer for administrative hearings and summary decisions
Regulatory Context
Attributes
7characterizing the safety of individual drugs
Documentation required when information is missing from a report.
Device labeling indicating it is intended for one use only; device labeled for single use only
The standard of information a user facility must report.
Retention period for records related to an adverse event
Evidence of benefit from everyday medical practice.
Timeframe for user facilities to submit individual reports
Identified Hazards
Hazards
1The consent form requires description of any reasonable foreseeable risks or discomforts.
Related CFR Sections (9)
- 21CFR803.32§ 803.32 If I am a user facility, what information must I submit in my individual adverse event reports?
You must include the following information in your report, if reasonably known to you, as described in § 803.30(b) . These types of information correspond generally to the elements of Form FDA 3500A:Read full regulation →
- 21CFR803.3§ 803.3 How does FDA define the terms used in this part?
Some of the terms we use in this part are specific to medical device reporting and reflect the language used in the statute (law). Other terms are more general and reflect our interpretation of the law. This section defines the following terms as used in this part:Read full regulation →
- 21CFR803.30§ 803.30 If I am a user facility, what reporting requirements apply to me?
(a) You must submit reports to the manufacturer or to us, or both, as specified in paragraphs (a)(1) and (a)(2) of this section as follows:Read full regulation →
- 21CFR803.33§ 803.33 If I am a user facility, what must I include when I submit an annual report?
(a) You must submit to us an annual report on Form FDA 3419. You must submit an annual report by January 1, of each year. You may obtain this form on the internet at: https://www.fda.gov/media/72292/download .Read full regulation →
- 21CFR803.19§ 803.19 Are there exemptions, variances, or alternative forms of adverse event reporting requirements?
(a) We exempt the following persons from the adverse event reporting requirements in this part:Read full regulation →
- 21CFR803.17§ 803.17 What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
If you are a user facility, importer, or manufacturer, you must develop, maintain, and implement written MDR procedures for the following:Read full regulation →
- 21CFR803.18§ 803.18 What are the requirements for establishing and maintaining MDR files or records that apply to me?
(a) If you are a user facility, importer, or manufacturer, you must establish and maintain MDR event files. You must clearly identify all MDR event files and maintain them to facilitate timely access.Read full regulation →
- 21CFR803.9§ 803.9 What information from the reports do we disclose to the public?
(a) We may disclose to the public any report, including any FDA record of a telephone report, submitted under this part. Our disclosures are governed by part 20 of this chapter .Read full regulation →
- 21CFR803.16§ 803.16 When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?
No. A report or other information submitted by you, and our release of that report or information, is not necessarily an admission that the device, or you or your employees, caused or contributed to the reportable event. You do not have to admit and may deny that the report or information submitted Read full regulation →
Related Warning Letters (10)
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-09-30
Medical Device Reporting/Misbranded
Insung Medical Co. Ltd.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-08-19
CGMP/QSR/Medical Devices/Adulterated
Les Encres LLC
- 2025-08-05
CGMP/QSR/Medical Devices/Adulterated
Mectronic Medicale S.R.L.
- 2025-07-22
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
O3UV, LLC
- 2025-07-08
Medical Device Reporting/Misbranded
Insightra Medical Inc.
- 2025-06-24
CGMP/QSR/Medical Devices/Adulterated
Aju Pharm Co., Ltd.
- 2025-06-03
CGMP/QSR/Medical Devices/Adulterated
DFI Co., Ltd.
See Also (8)
- Questions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA Staff (Status: Final)
- Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Safer Technologies Program for Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Content of Human Factors Information in Medical Device Marketing Submissions: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Off-The-Shelf Software Use in Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)