Medical Device Reporting (MDR) Requirements for ACME Device Company

1. Medical Device Reporting (MDR) Requirements for ACME Device Company Presented by: Dawn Fernandes – Safis Solutions, LLC

2. Objectives • Understand the regulatory requirements for Medical Device Reporting (MDR) that apply to manufacturers • Know what constitutes a reportable event • Understand the steps and time frames of the reporting process • Understand what happens with this data after a report is made

3. Regulatory Requirements for Medical Device Reporting (MDR) According to 21 CFR 803, the following parties mustsubmit MDRs to the FDA: • Manufacturers • Importers • Device User Facilities • Hospitals • Outpatient Diagnostic Facilities • Outpatient Treatment Facilities • Nursing Homes

4. Requirements for Manufacturers ACME is a manufacturer, as by definition a manufacturer is: Any person who manufacturers, prepares, assembles, or processes a device by chemical, physical, biological, or other procedure, including: • Domestic Manufacturers • Repackagers • Relabelers • Contract manufacturers • Specification Developers • U.S. Agents of Foreign Manufacturers

5. Requirements for Manufacturers Manufacturers must submit the following reports to the FDA: • Reports of individual adverse events no later than 30 calendar days after becoming aware of a reportable death, serious injury, or malfunction. • Reports of individual adverse events no later than 5 work days after becoming aware of: • A reportable event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health, or • A reportable event for which the FDA has made a written request.

6. Requirements for Manufacturers Manufacturers must submit the following reports to the FDA: • Supplemental reports - should you obtain further information concerning an event that was not submitted in an initial report.

7. Requirements for Manufacturers Manufacturers must also: • Establish MDR procedures (21 CFR Part 803.17) • Establish and maintain MDR event files (21 CFR Part 803.18)

8. Requirements for Manufacturers Additionally, both 21 CFR 803 and 21 CFR 820 require manufacturers to investigate events: Sec. 820.198 Complaint files (d) • Any complaint representing a reportable event must be: • promptly reviewed, evaluated, and investigated by a designated individual(s) • must be maintained in a separate portion of the complaint files or otherwise clearly identified. Sec. 803.50 (b) (3) • Manufacturers are also responsible for conducting an investigation of each event and evaluating the cause of the event.

9. Requirements for Manufacturers Additionally, both 21 CFR 803 and 21 CFR 820 require manufacturers to investigate events: • Any complaint representing a reportable event must be: • promptly reviewed, evaluated, and investigated by a designated individual(s) • must be maintained in a separate portion of the complaint files or otherwise clearly identified. • Investigations must include a determination of: • whether the device failed to meet specifications; • whether the device was being used for treatment or diagnosis; and • the relationship, if any, of the device to the reported incident or adverse event.

10. What is a ‘Reportable Event’? An event that a manufacturer becomes aware of that reasonably suggests that one of their marketed devices: • May have caused or contributed to a death or serious injury, or • Has malfunctioned and that the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

11. Clarify ‘Serious Injury” A reportable serious injury is defined as an injury or illness that is: • life-threatening, • Results in permanent impairment of a body function or permanent damage to a body structure; or • Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure Permanent means irreversible impairment or damage to a body structure or function, excluding trivial impairment or damage.

12. Clarify ‘Malfunction’ Malfunction is the failure of a device to meet its performance specifications or otherwise perform as intended. • Performance specifications include all claims made in the labeling for the device • Intended performance refers to intended use for which the device is labeled or marketed If the malfunction of a device or a similar device is likely to cause or contribute to a reportable death or serious injury if it were to recur, the event is reportable to the FDA

13. ‘Reasonably Suggests’? Information that reasonably suggests that a reportable event has occurred includes professional, scientific or medical facts, observations and/or opinions that would logically imply that a device has caused or may have caused or contributed to a reportable event. Caused or contributed meansa medical device was or may have been a factor in a reportable death or serious injury, or a death or serious injury was or may have been attributed to a medical device, including events resulting from:

14. How do I ‘become aware’? Become aware means that an ACME employee has acquired information that reasonably suggests a reportable adverse event has occurred. Manufacturers are considered to have become aware when: • Any employee becomes aware of an event • Any employee with management/supervisory responsibilities or responsibility to collect and report adverse events becomes aware that a reportable MDR event(s) necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health.

15. How do I ‘become aware’? Information concerning potentially reportable adverse events comes from both internal and external sources. • Internal • Trend Analysis • e.g., stability testing results • External • Customer Complaints • FDA notification/request The applicable ACME procedures should be followed for timely communication of potentially reportable events from all sources.

16. We’ve become aware - now what? Per the ACME procedure on Medical Device Reporting: • Designated individuals will review and evaluate the details of the adverse event to determine if it meets the threshold for a reportable event: • Quickly - time is of the essence. • According to a defined, standardized process. • Documenting all information that was evaluated and the rationale used in determining if a death, serious injury or malfunction was or was not reportable.

17. We’ve become aware - now what? If the FDA has not made a written request for 5 day reports for the event, and the designated individuals have determined the event to be reportable, the required reporting timeframe is determined: • 5working days for reportable events requiring remedial action to prevent risk of substantial harm to the public health, or • 30 calendar days for all other initial reports

18. We’ve become aware - now what? Per the ACME procedure on Medical Device Reporting, an Investigation will be initiated. • Investigations must include a determination of: • whether the device failed to meet specifications; • whether the device was being used for treatment or diagnosis; and • the relationship, if any, of the device to the reported incident or adverse event.

19. We’ve become aware - now what? Per the ACME procedure on Medical Device Reporting: • Potential impact and risk will be evaluated by designated individuals to determine the need for containment activities. This may include: • Internal Containment activities (21 CFR 820.90) • Product holds • Inventory reconciliation (scrapping bad product) • External Containment activities (21 CFR 803) • Corrections • Removals

20. Containment Activities • Product Holds • the quarantine of product still within the inventory or control of the manufacturer. • Correction • the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location. • Removal (a.k.a. Recall) • the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.

21. Completing the Report • The report must be forwarded using FDA MEDWATCH Form 3500A or an electronic equivalent as provided for under Part 803.14. • Forms may be obtained from any of the following resources: • The Consolidated Forms and Publications Office, Beltsville Service Center, 6351 Ammendale Rd., Landover, MD 20705; • FDA, MEDWATCH (HF-2), 5600 Fishers Lane, Rockville, MD 20857, 301-827-7240; • FDA, Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance, 10903 New Hampshire Ave., Bldg. 66, rm. 4521, Silver Spring, MD 20993-0002. • On the Internet at http://www.fda.gov/medwatch/getforms.htm

22. Completing the Report Manufacturers are required to report the information listed in 21 CFR Part 803.52, including: • Patient information (Form 3500A, Block A) • Information concerning the adverse event or product problem (Form 3500A, Block B); including outcomes attributed to the adverse event (e.g., death, serious injury) • Device information (Form 3500A, Block D), including device description, manufacturer information, implantation/explantation dates, etc. • Initial reporter information (Form 3500A, Block E). • Reporting contact information for all manufacturers (Form 3500A, Block G). • Device manufacturer information (Form 3500A, Block H).

23. Completing the Report The Device manufacturer information (Form 3500A, Block H) required includes: • Type of reportable event (death, serious injury, malfunction, etc.); • Type of follow-up report, if applicable (e.g., correction, response to FDA request, etc); • Summary of the evaluation of returned device. If an evaluationwas not performed, explain why this was not done • Device manufacture date (month, day, year); • Whether the device was labeled for single use;

24. Completing the Report The Device manufacturer information (Form 3500A, Block H) required includes: • Evaluation codes: event codes, method of evaluation, result, and conclusion codes (see FDA MEDWATCH Medical Device Reporting Code Instructions); • Whether remedial action was taken and the type of action; • Whether the use of the device was initial, reuse, or unknown; • Whether remedial action was reported as a removal or correction under section 519(f) of the act, and if so, provide the correction/removal report number

25. Where to send the Report FDA/CDRH Medical Device Reporting P.O. Box 3002 Rockville, MD 20847 20847-3002 Indicate on the envelope that it is a Manufacturer: • Initial Report • 5-day Report or • Supplemental Report, as applicable

26. Reporting Expectations Manufacturers are responsible for: • providing all information reasonably known to them • conducting an investigation of each event • evaluating the cause of each event • obtaining and providing missing information • explaining why information is incomplete Required information obtained after the initial report filing must be provided in a supplemental report.

27. Reporting Expectations All information reasonably known about the event includes: • Any information that can be obtained by contacting the reporter • Any information in your possession or • Any information that can be obtained by analysis, testing or other evaluation

28. Supplemental Reports A Supplemental Report should be submitted: • Whenever new information is acquired that was not provided in the initial MDR • Within 30 calendar days from receipt of the new information • Using Form 3500A, indicating that report is a supplement Provide the Manufacturer Report Number from the initial MDR; and, only complete those blocks of Form 3500A that are changing.

29. Exemptions Per Part 803.19, Manufacturers can request exemptions to reporting requirements. For example: • Alternative Summary Reporting (ASR) – a subset of the information required for FDA Form 3500A • Total Exemption - for specific device and/or patient related events • Remedial Action Exemption (RAE) - for recalled products covered by 21 CFR Part 806 (Corrections and Removals) • Exemption to submit a single MDR for one event where both Manufacturer and Importer have reporting responsibilities and requirements

30. When not to report An MDR is not required: • In cases of erroneous information, where a device-related event did not actually occur • When it is determined that the device in question was manufactured by another firm However, when a manufacturer receives this type of report, they should forward the report to FDA with an explanatory cover letter.

31. MDR Event Files Manufacturers must establish and maintain MDR event files. The files may be written or electronic and may refer to other information/files . Files must contain: • Information in manufacturer’s possession or references to information related to the event • Documentation of decision making processes used to determine if a death, serious injury or malfunction was/was not reportable • Copies of MDR forms and other information reported to FDA • An explanation of why information was not/could not be submitted to the FDA • Results of evaluations of each event

32. MDR Record Retention Manufacturers must retain MDR event files for the greater of: • 2 years from the date of the adverse event; or • a period of time equivalent to the expected life of the associated device If a device is no longer distributed, MDR event files must be maintained for the time periods described above. Manufacturers, like ACME, may maintain MDR event files within the Complaint files; however, they must be prominently identified as MDR reportable events.

33. How is MDR information used? Event reports are analyzed by FDA staff, including health care clinicians, engineers and scientists. Follow -up actions that the FDA may take include: • Requests for additional information • Conducting an investigation of event • Conducting an inspection at the manufacturer, importer or user facility • Contacting the manufacturer about a recall • Issuing a public health advisory/safety alert

34. How is MDR information used? Redacted versions of  medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers, are made publicly available via the MAUDE (Manufacturer and User Facility Device Experience) database on the CDRH web page. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM

35. Questions?

36. Activity time Please read through your assigned scenario and discuss with the other participants at your table. As a group, determine whether you believe the event to be a reportable adverse event. Provide your rationale as to why your group believes that the event is, or is not, reportable.