Contains Nonbinding Recommendations

Medical Device Reporting for

Manufacturers

This guidance represents the current thinking of the Food and Drug Administration (FDA or

Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or

statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office

You may submit written comments and suggestions at any time for Agency consideration to

http://www.regulations.gov. Submit written comments to the Division of Dockets

Rockville, MD 20852. Identify all comments with the docket number FDA–2013–D–0743.

Comments may not be acted upon by the Agency until the document is next revised or

updated.

1. Introduction ........................................................................................................................... 1

2. Manufacturer Reporting Requirements ................................................................................. 4

4. Specific Issues and Situations ............................................................................................. 27

................................................................................................................................................. 45

approach satisfies the requirements of the applicable statutes and regulations. If you

want to discuss an alternative approach, contact the FDA staff responsible for

implementing this guidance. If you cannot identify the appropriate FDA staff, call the

appropriate number listed on the title page of this guidance.

This guidance document describes and explains the Food and Drug Administration’s

references within this guidance document, are hyperlinked for your convenience.

FDA’s guidance documents, including this guidance, do not establish legally enforceable

responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and

should be viewed only as recommendations, unless specific regulatory or statutory

requirements are cited. The use of the word should in guidance documents means that

something is suggested or recommended, but not required.

(79 Fed. Reg. 8832, February 14, 2014,

03279.htm). FDA has modified this guidance based on that final rulemaking to ensure that the

recommendations in this guidance are consistent with the final rule.

1.2 What is the purpose of the MDR regulation?

The MDR regulation provides a mechanism that allows us (the FDA), as well as you (the

device manufacturer), to identify and monitor adverse events (deaths and serious injuries)

and certain malfunctions involving your medical devices. The goal is to detect and

4112). The Baseline Reporting requirement was removed from the regulation effective October 27, 2008

(73 FR 33692 and 73 FR 53686).

receive reports directly from user facilities, importers, or voluntary reporters. We may

prevent a risk of substantial harm to the public has occurred). Employees should be

trained to properly identify, collect, and report complaints to your formally designated

complaint handling unit [see 21 CFR 820.198(a) for requirements related to complaint

that it becomes aware of a reportable event. If the report involves a death, the user

If a user facility or importer uses the Form 3500A to report information to you about a

reportable event, you can add your manufacturer information to that form and submit it to

reportable). If a user facility or importer does not use the Form 3500A to report

information to you about an adverse event that is reportable under MDR, you need to

provide information for all appropriate sections of the 3500A (or an electronic

equivalent).

You may also receive adverse event information on a voluntary MedWatch Form 3500 or

report. This should be completed in a timely manner. Once you determine that the event

is MDR reportable, you must submit the report to us within the required time frame [refer

to 21 CFR 803.10, 803.11, 803.20, 803.50, and 803.52]. You must submit the report to

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2.12 What are my responsibilities for investigating a voluntary report

when the source of the report is unknown to me?

You will need to evaluate the available information in the complaint to determine

2.13 What is a “serious injury”?

803.3]:

It should also be noted that a device does not have to malfunction for it to cause or

contribute to a serious injury. Even though a device may function properly, it can still

Implants, Inc. v. U.S. Dep’t of Health & Hum. Servs., 584 F.3d 1290, 1301 (10th Cir. 2009).

11

The preamble reference is section 519(f), but the appropriate designation for the section is now section

12

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caused or contributed to a death or serious injury, a presumption that the malfunction is

the malfunction has not caused or contributed to further deaths or serious injuries and that

the likelihood of another death or serious injury occurring as a result of the malfunction is

the device, incidence rate for the malfunction, and assurance that complaints were

investigated to support the rationale for the decision to cease reporting. For further

information on exemption requests, refer to section 2.27 of this guidance. In this

situation, your firm should continue to report until FDA has responded and granted the

exemption request.

2.16 When does a complaint concerning a possible MDR reportable

• You have information that would enable a person who is qualified to make a

medical judgment to reasonably conclude that your device did not cause or

contribute to a death or serious injury, or that a malfunction would not be likely to

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• You determine that the information that you received is erroneous in that a

You should retain documentation of erroneous complaints and your conclusion that an

event is not an MDR reportable event in your MDR files for two years from the date of

the event or a period equivalent to the expected life of the device, whichever is greater.

[21 CFR 803.22(b)(2)].

2.17 If I am a contract manufacturer, when do I need to obtain an

The MDR regulation at 21 CFR 803.3 defines a “manufacturer” to include a firm that

initiates specifications for devices that are manufactured by a second party for subsequent

distribution by the person initiating the specifications. A contract manufacturer who does

not distribute or market the devices it manufactures for a specifications developer would

not have an MDR reporting obligation under 21 CFR 803.50 and would not require an

exemption. However, if the contract manufacturer (Firm A) distributes or markets the

exemption should provide a description of any agreement between the firms pertaining to

MDR reporting for events involving the device. Both firms should maintain

documentation of such agreement in their MDR procedures. Such an agreement does not

negate a manufacturer’s responsibilities to comply with any exemptions, variances, or

reporting alternatives that the FDA grants, or any other applicable requirement.

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2.18 What types of reports are required by the MDR regulation?

You are required to submit three types of MDR reports. Each type of report must be

submitted within the mandatory time frame. The following are the three types of reports:

2.19 What are 30-day reports?

must be submitted as described in section 2.7 of this guidance. You will ordinarily

submit 30-day reports for MDR reportable events, but you may be required to submit 5-

day reports under certain circumstances as described in section 2.20 of this guidance.

• Patient information [21 CFR 803.52(a)];

• Device information [21 CFR 803.52(c)];

• Initial reporter information [21 CFR 803.52(d)];

• Reporting information, including manufacturer contact information, and the report

sources, date, type, and number [21 CFR 803.52(e)]; and

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2.20 What are 5-day reports?

substantial harm to the public.

However, when you receive a written request for 5-day reports from us, you must submit

the applicable reports within 5 work days after the day any employee becomes aware of

the event [21 CFR 803.10(c), 803.20, 803.53].

2.21 What is a “remedial action,” and are all adverse events associated

with “remedial actions” reportable to FDA as 5-day reports?

Under the MDR regulation, a “remedial action” is any action, other than routine

A decision that a remedial action is necessary can be based on any information, including

to the public health [21 CFR 803.50] the reportable adverse events should be submitted

See 60 Fed. Reg. at 63581-63582.

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decision to initiate the remedial action because this is a remedial action to prevent an

unreasonable risk of substantial harm to the public health, and have filed 5-day reports

subsequent additional reportable events associated with that specific remedial action (i.e.,

The Remedial Action Exemption (RAE) Guidance document [RAE Guidance] lists

criteria under which FDA will consider granting an exemption from a reporting

requirement under 21 CFR 803.19.

information required under 21 CFR 803.50 that was not known or available to you at the

time you submitted your initial 30-day or 5-day report [21 CFR 21 CFR 803.56]. We

consider a supplemental report to be required when new facts prompt you to alter or

supplement any information or conclusions contained in the original MDR or in any prior

supplemental reports.

The supplemental information must be submitted within one month (30 calendar days)

following receipt of the information [21 CFR 803.56]. Supplemental reports must be sent

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• List the appropriate identification number of the report that you are updating

with the supplemental information (i.e., the manufacturer report number of the

initial MDR).

supplemental report for new information if you would not have been required to report

that information had it been known or available at the time you filed your initial MDR.

You must maintain all supplemental reports in your MDR files [21 CFR 803.18]. You

must also document in your files when you decide not to submit any new information in a

supplemental report [21 CFR 803.18].

2.23 What level of effort must I make to obtain additional information

(including email) request for information. Your MDR files should include a record of

each attempt to obtain information, and the nature of the response by the reporter [see 21

then your initial report must reflect that fact [21 CFR

803.52(b)]. If your initial report

was submitted as a malfunction and you learn a patient died or suffered a serious injury,

then your supplemental report should change the event type to death or serious injury, as

appropriate [21 CFR 803.52(f)(1)].

All of this information is subject to review by us to determine if you made a good faith

2.24 When will you request additional information from me about an

event for which I submitted an MDR report?

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• Information in your possession or references to information related to the adverse

investigations), including all documentation of the deliberation and decision-

You should also include the name and title of the person who made the decision.

When applicable, the final assessment should indicate the cause of the event and

what action, if any, you took to assure that the cause of the event was corrected or

otherwise mitigated.

of the initial record and information related to the event. These records should

include the available information needed to complete your report. The record

may be a documented telephone call, a letter or fax, a service report, a voluntary

3.3 What information contained in my MDR reports is subject to public

disclosure and what information will not be disclosed?

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• Names and other identifying information of a third party that voluntarily submits

information [21 CFR 803.9(b)(2)].

When a user facility submits a report concerning one of your devices, as required by the

MDR regulation, we will not disclose the identity of the facility except in connection

with [21 CFR 803.9(c)]:

No, the submission of a report or related information to us and our release of that

information is not necessarily an admission that you, your employees, or your device

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4.1 Delay in Surgery

4.1.1 For several years our firm has submitted an MDR for any

issue?

by you would be likely to cause or contribute to a death or serious injury if the