The Federal Food, Drug, and Cosmetic (FD&C) Act, Section 519 grants FDA the authority to require mandatory MDRs for device related adverse events and certain malfunctions from manufacturers, importers, and device user facilities. Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these device types. Requirements of MDRs are found in 21 CFR Part 803 and are applicable to Premarket Notifications (510(k)), Premarket Approvals (PMA), De Novo Classification Requests (De Novo Requests), Humanitarian Device Exemptions (HDE), as well as devices licensed as biological products (BLAs) under section 351 of the Public Health Service Act .
What type of mandatory MDRs are required under 21 CFR Part 803?
Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities provide a summary of the types of mandatory reports and reporting time frames.
What are MDR reportable events?
The Medical Device Reporting for Manufacturers guidance document describes and explains the FDA’s current regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for device-related adverse events and certain malfunctions. The Manufacturer and User Facility Device Experience (MAUDE) database contains mandatory reports submitted to FDA by mandatory reporters (manufacturers, importers and user facilities) and voluntary reporters such as health care professionals, patients and consumers.
What is Voluntary Malfunction Summary Reporting?
The Voluntary Malfunction Summary Reporting (VMSR) program was established in 2018 and permits manufacturers to report certain device malfunction MDRs in summary form on a quarterly basis.The eligibility status of a given device product code for summary reporting under the VMSR program is listed in the FDA’s searchable Device Product Classification Database.
What are Medical Device Classification Product Codes?
Medical Device Classification Product Codes are a method of internally classifying and tracking medical devices. Product codes consist of a three-letter combination (e.g. KSR) that associates a device’s type with a product classification designated for the application, such as device name, regulation, medical specialty, device class, or device review panel. Please refer to Medical Device Classification Product Codes – Guidance for industry for additional information.
The product codes for licensed devices are generated using the principles which apply to most other FDA regulated products; therefore, they follow a different, seven-character alphanumeric product code structure (e.g. 57 V H-05). These product codes are primarily used for importation and inspection purposes. Additional information related to import product codes can be accessed using the link provided under the Related Additional Resources section below.
For the purpose of MDR, CBER has created product codes listed below for devices licensed as biological products under the Public Health Service Act (i.e., manufacturers of licensed in vitro diagnostics required for blood donor screening and related blood banking practices).
- QHM: Serology tests used for infectious disease screening of blood and plasma donations
- QHO: Licensed NAT tests used for infectious disease screening of blood and plasma donations
- QHR: Blood Grouping Reagents
- QHS: Anti-Human Globulin
- QHT: Red Blood Cell Reagents
How do I submit MDRs for devices licensed as biological products?
On February 13, 2014, the FDA published a final rule on Electronic Medical Device Reporting (eMDR) that requires manufacturers and importers to submit MDRs to the FDA in an electronic format in accordance with 21 CFR 803.12(a) and 803.20, unless granted an exemption under 21 CFR 803.19.
Links to the form, form instructions, questions and answers, and related resources on the eMDR (e.g. applicable regulations) system are found below.
- Electronic Medical Device Reporting - eMDR
- Federal Register – Medical Device Reporting: Electronic Submission Requirements
- Guidance Document - Questions and Answers about eMDR – Electronic Medical Device Reporting
- eMDR - Electronic Medical Device Reporting
- General Instructions – for Form FDA 3500A MedWatch (for Mandatory Reporting)
Are there any special instructions for submission of MDRs for licensed medical devices?
To improve quality of MDRs for licensed medical devices, CBER strongly encourages reporters to include the following information under Section D (Suspect Medical Device) and G (All Manufacturers) of the CDRH-MedWatch Form 3500A.
- Device brand name
- BLA number
Procodes are included on the BLA, PMA, De Novo, HDE approval and 510k clearance letter. In the event the procode is unknown, it can be identified using the Product Classification Database.
Where can I obtain help if I have questions about MDR reporting for devices licensed as biological products or the MDR regulations?
For questions regarding submissions of MDRs for devices licensed as biological products
- Call: (800) 835-4709 or (240) 402-8010
- Email: email@example.com
Or Write to:
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002
For general questions on MDRs including interpretation of MDR policy:
- Call: (301) 796-6670
- Email: MDRPolicy@fda.hhs.gov
Or write to:
MDR Policy Branch
Division of Postmarket Surveillance
Office of Surveillance and Biometrics
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
WO Bldg. 66, Room 3217
Silver Spring, MD 20993-0002
Related additional resources: