Medical Device Reporting for Manufacturers : Guidance for Industry and Food and Drug Administration Staff

Description

Thisguidance documentdescribes and explains the Food and Drug Administration’s (FDA, we, us) current regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for device-related adverse events and certain malfunctions. These requirements are contained in our Medical Device Reporting (MDR) regulation at Title 21, Code of Federal Regulations (CFR), Part 803, as authorized by section 519 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). References to FDA regulations and Federal Register documents, as well as cross-references within this guidance document, are hyperlinked for your convenience.

Scope & Applicability

Regulatory Context

• 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 →

• 21CFR803.50§ 803.50 If I am a manufacturer, what reporting requirements apply to me?

  (a) If you are a manufacturer, you must report to us the information required by § 803.52 in accordance with the requirements of § 803.12(a) , no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a deviRead full regulation →

• 21CFR803.52§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse event reports?

  You must include the following information in your reports, if known or reasonably known to you, as described in § 803.50(b) . These types of information correspond generally to the format of Form FDA 3500A:Read full regulation →

• 21CFR803.20§ 803.20 How do I complete and submit an individual adverse event report?

  (a) What form must I complete and submit ?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 →

• 21CFR803.1§ 803.1 What does this part cover?

  (a) This part establishes the requirements for medical device reporting for device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintaiRead 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 →

• 21CFR803.18§ 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 →

• 21CFR803.22§ 803.22 What are the circumstances in which I am not required to file a report?

  (a) If you become aware of information from multiple sources regarding the same patient and same reportable event, you may submit one medical device report.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 →

• 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 →

• 21CFR803.42§ 803.42 If I am an importer, what information must I submit in my individual adverse event reports?

  You must include the following information in your report, if the information is known or should be known to you, as described in § 803.40 . These types of information correspond generally to the format of Form FDA 3500A:Read full regulation →

• 21CFR803.12§ 803.12 How do I submit initial and supplemental or followup reports?

  (a) Manufacturers and importers must submit initial and supplemental or followup reports to FDA in an electronic format that FDA can process, review, and archive.Read full regulation →

• 21CFR803.13§ 803.13 Do I need to submit reports in English?

  Yes. You must submit all reports required by this part in English.Read full regulation →

• 21CFR803.15§ 803.15 How will I know if you require more information about my medical device report?

  (a) We will notify you in writing if we require additional information and will tell you what information we need. We will require additional information if we determine that protection of the public health requires additional or clarifying information for medical device reports submitted to us and Read full regulation →

• 21CFR806.10§ 806.10 Reports of corrections and removals.

  (a) Each device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer if the correction or removal was initiated:Read full regulation →

• 21CFR7.3§ 7.3 Definitions.

  (a) Agency means the Food and Drug Administration.Read full regulation →

• 21CFR803.56§ 803.56 If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?

  If you are a manufacturer, when you obtain information required under this part that you did not provide because it was not known or was not available when you submitted the initial report, you must submit the supplemental information to us within 30 calendar days of the day that you receive this inRead full regulation →

• 21CFR803.10§ 803.10 Generally, what are the reporting requirements that apply to me?

  (a) If you are a device user facility, you must submit reports (described in subpart C of this part ), as follows: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 →

• CGMP/QSR/Medical Devices/Adulterated

  Envoy Medical Inc.

  2025-12-09

• CGMP/QSR/Medical Devices/Adulterated/Misbranded

  Royal Philips

  2025-10-28

• CGMP/QSR/Medical Devices/Adulterated

  LEVO AG

  2025-10-21

• CGMP/QSR/Medical Devices/Adulterated

  Technological Medical Advancements LLC

  2025-10-07

• Medical Device Reporting/Misbranded

  Insung Medical Co. Ltd.

  2025-09-30

• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device

  SeniorLife Technologies, Inc.

  2025-09-16

• CGMP/QSR/Medical Devices/Adulterated

  Les Encres LLC

  2025-08-19

• CGMP/QSR/Medical Devices/Adulterated

  Mectronic Medicale S.R.L.

  2025-08-05

• CGMP/QSR/Medical Devices/Adulterated/Misbranded

  Visgeneer, Inc

  2025-08-05

• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device

  O3UV, LLC

  2025-07-22

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• CPG Sec. 300.500 *Reprocessing of Single Use* Devices (Status: Final)
• Medical Device Reporting for User Facilities (Status: Final)
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• Sterilized Convenience Kits for Clinical and Surgical Use: Final Guidance for Industry (Status: Final)
• Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers (Status: Final)