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Document issued on: February 13, 2014
The draft of this document was issued on August 21, 2009.
For questions regarding this document contact Sharon E. Kapsch, 301-796-6104, Sharon.Kapsch@fda.hhs.gov.
U.S. Department of Health and Human ServicesYou may submit written comments and suggestions at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, (HFZ-305), Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register. Comments may not be acted upon by the Agency until the document is next revised or updated.
Additional copies are available from the Internet. You may also send an e-mail request to CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number 1679 to identify the guidance you are requesting.
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the 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.
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This guidance is intended to answer questions related to FDA’s final rule requiring device manufacturers and importers to submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs), to the Agency in an electronic format that FDA can process, review, and archive (hereinafter referred to as the eMDR Final Rule).1 Electronic reporting is also available to user facilities, however, the eMDR Final Rule permits user facilities to continue to submit only written reports to FDA. The requirements of this final rule will take effect on August 14, 2015. This guidance provides general information regarding how to prepare and send an electronic postmarket medical device report to the Center for Devices and Radiological Health (CDRH) in FDA. The guidance also identifies where you can find more detailed information on the preparation and transmission of the reports.2
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 Agency guidances means that something is suggested or recommended, but not required.
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For over 20 years, FDA received postmarket MDRs in a paper format through the mail. The eMDR Final Rule requiring the electronic submission to FDA of manufacturer and importer MDRs is an important step toward improving the Agency’s systems for collecting and analyzing postmarket MDRs. When FDA receives data elements in a paper format, the information must be manually entered into our internal electronic database before it can be effectively reviewed and analyzed. This process is extremely time consuming, costly, and susceptible to data entry errors. Electronic submission of MDRs will have the following benefits:
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Specific requirements for the submission of postmarket MDRs to FDA are in 21 CFR Part 803. This guidance document addresses general issues related to the electronic submission of postmarket MDRs and provides links to more detailed information on the preparation of an electronic MDR (eMDR) submission.
What is an electronic MDR submission?
For the purposes of this guidance, an eMDR submission is a file containing one or more medical device reports in an electronic format that FDA can process, review, and archive.
What information do I need to include in my electronic MDR?
The MDR regulation (21 CFR Part 803) specifies the types of reports and the data elements required in an MDR. An eMDR contains the same data elements. Importers must include the information specified in 21 CFR 803.42. Manufacturers must include the information specified in 21 CFR 803.52. User facilities must include the information specified in 21 CFR 803.32. Although the eMDR Final Rule permits user facilities to continue to submit MDRs on paper, user facilities may instead choose to submit MDRs in an electronic format.
What is the format of an electronic MDR?
FDA's current data system was developed to process, review, and archive MDRs configured according to the Health Level Seven Individual Case Safety Report (HL7 ICSR) message format. An MDR is made up of data element identifiers and the associated data element value in a machine-readable format. For specific information on data element identifiers used by both of the reporting options discussed below, see the Health Level Seven (HL7) Individual Case Safety Report (ICSR) Release 1: Implementation Guide for FDA Medical Device Reporting.
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What do I need to do to start submitting MDRs electronically to FDA?
To submit MDRs electronically, you will need to set up a Web Trader Account and then submit test data that is successfully processed through the ESG before you receive a production account to use for your MDR submissions. Here is the process for beginning to file eMDRs:
Detailed instructions can be found at: Setting up a WebTrader Account Checklist
Additional information about the ESG is available at: Electronic Submissions Gateway.
How do I prepare an electronic MDR submission?
You can choose from two options to create your eMDR submission. More information on the two options for filing eMDRs is available at: Electronic Medical Device Reporting (eMDR).
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The eSubmitter program is a free, downloadable application that allows users to create one report at a time. With eSubmitter, the user manually enters the required MDR information into the eSubmitter program. The program contains data elements that correspond with 21 CFR 803.32, 803.42, and 803.52, and generates the .xml message, in HL7 ICSR format, needed to successfully transmit the report via the ESG.
The eSubmitter program allows the user to print a copy of the submitted report(s) and allows the attachment of labeling or other documents to the initial report or to a supplemental or follow-up report.
The eSubmitter program and installation instructions are free and available at: eSubmitter Download and Installation.
This option provides the capability to create and submit eMDRs either individually or in batches (containing multiple individual reports in a single submission). Entities who choose this option are encouraged to develop systems that can save or print the resultant report and that can encode attachments into their eMDRs.
You can find more detailed information on these two methods of preparing an eMDR at: eMDR – Electronic Medical Device Reporting.
How should I complete a data field (a field where a user can type information) if I do not have information for the field?
For Health Level Seven (HL7) Individual Case Safety Reporting users, the HL7 ICSR schema provides for several values that may be used when there is no information to enter in an optional field:
These “null values” are added to the code of the HL7 ICSR message to further clarify why data is not being provided. Information on how to properly implement null values is found at: Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files.
(At that site, click the link for "Complete Packet: eMDRHL7files.zip" and select the ICSR Implementation Technical Specification document, which answers the question "How do I address null values?").
For eSubmitter users, if you have no information to provide for a given data field, and eSubmitter does not allow the selection of a null value for that field, you should leave the field blank.
How do I know if my submission of an electronic MDR was successful?
FDA’s system will automatically route three separate electronic acknowledgments to the user's ESG account. These acknowledgements indicate the stage of processing that the eMDR has reached:
If there are no errors, we anticipate that the three acknowledgement letters will be generated the same day or within 24 hours of the submission.
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What date does FDA consider the receipt date for an electronic MDR?
FDA considers the receipt date for an eMDR to be the date the eMDR arrived at the ESG (Acknowledgment 1), but only if the eMDR is successfully loaded in the CDRH database (a passing Acknowledgment 3). If a failure occurs during the validation or loading process, the error is described in Acknowledgment 3. The reporting entity should correct the error(s) and resubmit the eMDR. If the resubmitted eMDR is successfully loaded, (a passing Acknowledgment 3), the receipt date will be the date that the resubmitted eMDR arrived at the ESG, as documented in the Acknowledgment 1 issued for the resubmitted eMDR.
The time zone should not be a concern for timely reporting under MDR. Although Acknowledgment 1 displays both the date and time according to the Eastern Standard Time (EST)/Eastern Daylight Time (EDT) zone, MDR considers only the date for the purposes of calculating timely reporting. If the report is successfully loaded, this processing should take no more than an hour. Although Acknowledgment 1 displays EST/EDT, FDA will consider the local time of the submitter when determining the submission date, just as a postmark date is used for mailed paper reports.
What should I do if Acknowledgment 3 notifies me of validation and loading error(s) in my electronic MDR?
If you submit an eMDR individually (not as part of a batch), and receive an Acknowledgment 3 that states that your report has failed to load, the Acknowledgment 3 will describe the error(s). You should correct the error(s) and resubmit the eMDR, at which time you will receive another set of three acknowledgments.
If you submit an eMDR as part of a batch, Acknowledgment 3 will list all the reports in the batch and indicate whether each report has passed or failed to load. You should correct the error(s) for the failed reports and resubmit the FAILED reports ONLY. You should not resubmit the entire original batch. When you resubmit the report(s) that contained errors, you will get another set of three acknowledgments for the resubmitted eMDR(s).
Errors that will prevent successful loading in the CDRH database of an eMDR include:
If you need help interpreting error messages in Acknowledgment 3, send an e-mail to eMDR@fda.hhs.gov.
What should I do if I send my eMDRs and do not receive one or more of the acknowledgments?
If you do not receive Acknowledgment 1 or 2, check the status of the ESG at: Electronic Submissions Gateway (ESG) - System Status. If the ESG system status website indicates the ESG is operating normally, contact the ESG Staff at ESGHelpDesk@fda.hhs.gov.
If you do not receive Acknowledgment 3, check the eMDR Status Page. If the eMDR system status website indicates that eMDR is operating normally, contact eMDR@fda.hhs.gov.
Should I keep a copy of the eMDRs that are in my electronic MDR submission? Should I keep the acknowledgments?
Yes, under 21 CFR 803.18(b)(1)(ii) of the eMDR Final Rule, an entity is required to keep paper or electronic copies of all reports submitted to us or to importers, distributors, or manufacturers. In addition, under 21 CFR 803.18(b)(1)(iii) of the eMDR Final Rule, an entity must keep copies of all electronic acknowledgments sent by FDA in response to the entity's eMDRs.
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How do I update a report?
Under 21 CFR 803.12 of the eMDR Final Rule, manufacturers and importers must submit supplemental or follow-up reports to FDA in an electronic format that FDA can process, review and archive. User facilities may submit follow-up reports to FDA in an electronic format, but are still allowed to report only on paper in accordance with 21 CFR 803.12(b).
The options for preparing and transmitting a supplement or follow-up report are the same as those for initial reports, discussed above. For all updates, you should include the initial report number and state that the type of submission is a follow-up report. Limit your additional entries to those where you need to update previously provided information. For example, if patient age and sex are unchanged, do not include them in your supplement or follow-up report. If you are updating or correcting the model number, provide the corrected information only. A submitter should use electronic submissions for supplemental or follow-up reports even for MDRs that were initially filed on paper.
Can a reporting entity respond to an FDA Request for Additional Information (AI) electronically?
If FDA requests additional information for an MDR under 21 CFR 803.15, you are encouraged to submit the response electronically.
A manufacturer responding to an FDA request for additional information, using the 3500A format, should enter the initial report number, indicate in Block H2 that the type of follow-up is a “Response to FDA Request,” and provide the requested information in Block H10/11, Additional Manufacturer Narrative. Any discrete data elements should also be reported in Block H10/11. You may submit the letter you received as an attachment to the submission.
The FDA request for AI may give the manufacturer the option to respond using email to the FDA sender. The manufacturer's email response should include the identifying information specified in the AI request.
A communication from FDA to a user facility or importer that requests additional information will provide instructions for responding to the sender. That response should include the identifying information specified in the AI request.
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How will I learn of future changes to software, data fields and code lists?
FDA is committed to providing industry with adequate notice of any specification changes and, when possible, will ensure previous versions of such specifications can still be utilized to submit adverse events electronically. We will utilize our websites for MDR, eMDR, and FDA ESG as well as Federal Register notices and updates to this guidance (when appropriate) to provide sufficient advance notification of changes to all stakeholders. We will work with stakeholders on implementation of the changes and expect to support previous specifications long enough to ensure that HL7 and eSubmitter users are able to make the necessary changes.
What should I do if a System Outage prevents me from filing an electronic MDR on time?
The FDA ESG website provides notification of scheduled maintenance and maintains a status history that documents unscheduled down time for the FDA ESG. The CDRH eMDR website provides notification of scheduled maintenance for the CDRH eMDR processing system. Typically, an ESG or CDRH eMDR processing system outage will not last more than 24 hours and should not require an extension of time. However, if a manufacturer or importer is unable to submit a report on time due to an outage affecting the ESG or the CDRH eMDR processing system, it may document its attempts at timely filing in Block H10 for the affected reports and submit reports electronically as soon as the ESG or CDRH eMDR processing system is operational.
A reporting entity using an HL7 reporting option should plan for a backup method of reporting for an outage affecting its own system. If a reporting entity experiences an outage within its own system that will affect timely reporting, it should contact FDA at the eMDR email address, eMDR@fda.hhs.gov. The email should provide FDA with information on the problem, the number of reports affected, and an estimate of how long it will take to resolve. We will respond to provide instructions on alternatives for submission of the adverse event reports. A description of the problem with the electronic submission should be documented in Block H10 for the affected reports before they are submitted.
When an alternative method is used during a system outage, FDA will respond with an Acknowledgment 3 that documents that the report has been successfully loaded in the CDRH database or failed to load due to specified errors. In these instances, the reporting entity will not receive an Acknowledgment 1 or 2.
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Where can I find technical information concerning the eSubmitter software?
Technical information, e.g., information on downloading the software, on the eSubmitter system is accessible at eSubmitter Download and Installation.
Where can I find technical information concerning the HL7 ICSR?
Technical information, including technical specifications, on the HL7 ICSR is accessible at Health Level Seven (HL7) Individual Case Safety Reporting
Who do I contact if I cannot find the answer to my question?
For general questions on eMDR submissions, e-mail eMDR@fda.hhs.gov. For questions concerning the FDA Electronic Submissions Gateway (ESG), please contact the ESG staff as indicated on their Web site.
For questions about the MDR regulation and reporting, you may call 301-796-6670 or send an email to MDRPolicy@fda.hhs.gov
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1 The eMDR Final Rule, which amends 21 CFR Part 803, can be found in 79 FR DOC 2014-03279, February 13, 2014.
2 See eMDR – Electronic Medical Device Reporting.
The non-repudiation agreement allows the FDA to receive electronically signed submissions in compliance with 21 Code of Federal Regulations (CFR) 11.100. You can find sample letters of non-repudiation agreement at http://www.accessdata.fda.gov/esg/userguide/webhelp/Sample_Letters_of_Non-Repudiation_Agreement.htm
A digital certificate is an attachment to an electronic message that allows the recipient to authenticate the identity of the sender via third- party verification from an independent certificate authority. Digital certificates are used to identify encryption and decryption codes between message senders and recipients. Information on the FDA ESG and digital certificates is available at Important Information About Digital/Electronic Signatures.
Today’s medical device OEMs live in an age of abundance: both abundant options and abundant regulatory requirements. With so many options and so many restrictions, it can be very difficult to select the right contract manufacturer (CM) or electronics manufacturing services (EMS) provider. So many factors come into play. What are their testing services? Do they have clean room capabilities? How do our corporate cultures mix? Will this be a long-lasting or one-time relationship? Could they help me with miniaturization?
Fig. 1 – A Suntron employee at a SMT machine, which places all of the components. (Photo © 2013 George Tenney) Below are some of the most important qualities to consider when choosing an EMS provider. This article will take you through the questions you need to ask before you choose the perfect manufacturing partner for your device.
One of the first qualities that a medical device company should evaluate prior to beginning a partnership with a CM is its quality system. “In my mind,” said Tim Craumer, Regional Sales Manager at Suntron Corporation, Phoenix, AZ, “there are two primary aspects to consider in a contract manufacturer’s quality system. The first is the overall quality system that drives the entire company.” At its most basic, this umbrella system involves having both the correct qualifications (FDA registration, ISO13485 certification, and cGMP) and the proper controls in place to monitor the quality system. But there are also other important questions to ask. What is the documentation like? How are they tracking your product on its path through the manufacturing floor? These processes should be clearly outlined when you are selecting a CM partner. If the information is not available in the company literature or on the corporate website, be sure to ask them specifically.
“The second component is focused more on the manufacturing and test process requirements specific to your project,” said Craumer. “Are these processes developed to the point that the outcome is predictable, repeatable, and results in good quality?” A trusted medical device EMS provider will have the ability to evaluate, document, and retain the data resulting from these processes. They should be able to reference this data whenever necessary and satisfy FDA or other regulatory requirements. “The outcome should be predictable,” agreed Jen Winters, Marketing Manager at Suntron, “and you should feel secure that if your EMS provider simply follows the structure they’ve created, the product will come out the same every time.”
Another consideration is the EMS provider’s strength of engineering. Of course, the term “engineering” takes on a variety of different meanings and constitutes a lot of different activities, depending on the industry. “When we talk about engineering in the context of the design, development, and manufacture of a medical device,” said Craumer, “what is critical at the EMS level is their expertise and experience. Not only should the EMS provider be able to generate the repeatable processes mentioned above, they should also be willing to invest the time and effort of understanding the functionality of the device and to perform an analysis regarding the manufacturability of the device.” When they perform that analysis, OEMs gain access to an in-depth knowledge about their device before the manufacturer has even started building the first part.
Why would you want that knowledge? After all, in a typical customer-manufacturer agreement, it is understood that the customer has designed the product to meet contractual quality standards, while the manufacturer has implemented process controls to ensure high quality and on-time delivery. However, even when both parties fulfill these promises, unexpected defects and field failures can occur. A Design for Manufacturability process review provides an additional, objective engineering resource for the customer engineering design team to mitigate or avoid these unforeseen issues. It allows customers to ship a better product to market more quickly— and isn’t that why you hired a CM in the first place?
Fig. 2 – BGA (ball grid array) hand production on a medical printed circuit board. (Photo © 2013 George Tenney) This may seem like the most basic of the CM requirements, but it presents a surprisingly complex question. Does the EMS provider have the capabilities to manufacture the device you need? This is probably most relevant for OEMs of Class 2 and Class 3 devices, where miniaturization is a growing priority. Winters explained: “Miniaturization is not simply about shrinking the size of the device, but also decreasing the weight, extending the battery life, and reducing power consumption. It is essential that a contract manufacturer have the ability to place and test small package components on circuit boards. For example, here at Suntron, we have the ability to place and test a small 01005-size surface mount technology (SMT) component.” While your device may not be that small yet, if you are looking for a CM with whom to have a lasting relationship, it is important that they can evolve alongside your company. (See Figure 1)
Another aspect of the manufacturing process which can prove important for medical devices is a clean room manufacturing environment. As with miniaturization, this is a concern that is especially relevant for Class 2 and Class 3 devices. Since these devices may be implanted or used inside the body, contamination could prove fatal. A clean room environment is also essential if you want a CM who can build a complete device and ship it directly to market (or through the OEM). (See Figure 2)
It is important that a contract manufacturer not only have the ability to test devices, but that they can offer different levels of testing. From basic flying probe tests to more complex in-circuit board assembly tests and full functional tests, a qualified EMS provider will have several options to meet the OEM’s requirements. “If you are building to final device level,” said Craumer, “your EMS partner should definitely provide a functional test. This is a key verification step that ensures your device is working correctly and built to standard.”
Above, it was mentioned that CMs should be able to place small form factors, but once they are placed, the CM should also be able to test them. “Some companies do not want to make an investment in the new equipment and training necessary to inspect and test such tiny, tiny devices,” explained Winters, “It introduces all kinds of new issues with processes that may have already been in place. You have to modify them because the items are now so small.” Craumer added: “Make sure you choose a company that has made this investment. Rework is costly; device recall is exponentially more costly. It is better that the OEM have a partner who will identify any issues during the device manufacturing process versus finding it after the device is already in the field.”
It can be incredibly convenient to have an EMS provider who will package, seal, and ship your product in addition to manufacturing it. However, not many EMS providers in the market have direct ship capability for medical products.
Part of this shortage is the necessity of a clean room for many packaging applications. “The clean room is crucial for packaging a variety of applications,” explained Craumer, “For example, we are building a Class 2 orthopedic device right now inside of a clean room. As soon as we are done with the manufacturing, we can seal it in a medical bag in that same room.” Suntron maintains clean rooms in all of its facilities for this reason. By keeping the process to one room, they can be confident in the product integrity and ensure ease of manufacturing for the medical device company. “We also manage the sterilization and biohazard screening of these devices,” continued Craumer, “Once they are released from quarantine, we package and box the product in our customer’s packaging. At that point, we ship to our customer, or to our customer’s customer in the market.”
This is not to say that all medical devices need to be built in a clean room. “We have several devices that we build, package, and ship with the paperwork and everything, and they never touch the clean room,” said Winters, “However, many of our customers appreciate having the clean room capabilities. They see it as an indication of our commitment to quality and meeting specific customer and regulatory requirements.”
Unfortunately, a company’s manufacturing responsibilities do not always end once the product is out the door and in the market. Devices can stop functioning. They can require upgrades. They may need to be recalibrated, retested, or reinspected.
“When an EMS provider can handle refurbishment and depot repair,” said Craumer, “that can be a big help to medical device OEMs who don’t have the staff to manage that sort of work. Having that ability and then being able to provide sterilization and packaging services is a truly valuable asset.”
At first glance, this can seem like the least important of an EMS provider’s qualifications. While it’s always more pleasant to work with a company that understands and appreciates your vision, many OEMs would place more emphasis on the practical points made above than on culture compatibility. However, a CM’s culture can arguably have the most long-term effect on your company.
Understand that the company you chose needs to have a culture that complements and expands your current values as well as where you like to be in the future. “As an extension of your company, your partner should be committed to being there in difficult times. This is important to your long-term success— after all, this is manufacturing, so difficult times do happen. The CM’s commitment to continuous improvement should make both companies better the longer the relationship,” said Winters.
Craumer concurred, “Before choosing a CM, it’s important that you visit the company and take a tour of their manufacturing area. Engage them in discussions about their quality systems. Ask about their engineering expertise. Understand the manufacturing and test processes that are in place. Your manufacturer should be extremely knowledgeable, and that knowledge should shine through in their answers. If they have that expertise, they’ll most likely be ready to adapt to your changing needs with unique, outside-the-box solutions.”
The most important question at hand, however, may be “How will this EMS provider or CM affect my total cost of ownership?” When you outsource manufacturing, you want to be sure you are getting the cost benefits you expect. Your EMS provider should be a resource for you in every way: engineering, inspections, quality, and cost. Otherwise, they aren’t worth hiring. Remember, total cost of ownership is not purchase order price. In the end, this is real value.
This article was supplied by Suntron Corporation, Phoenix, AZ. For more information, Click Here .