Medical Device Reporting (MDR) Requirements the New FDA Draft Guidance

Transcription

1 Medical Device Reporting (MDR) Requirements the New FDA Draft Guidance February 27, 2014 Jeffrey K. Shapiro (202)

2 Essential Requirements n Submit MDR reportable events to FDA (21 CFR (c), ) n Establish and maintain written procedures to review complaints for MDR reportability (21 CFR , ) n Establish and maintain complete MDR files (21 CFR , ) 2

3 Definition of Reportable Event (21 CFR 803.3) n MDR reportable event (or reportable event) means: An event that manufacturers or importers become aware of that reasonably suggests that one of their marketed devices: (i) May have caused or contributed to a death or serious injury, or (ii) Has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. 3

4 Elements of an MDR Reportable Event n Manufacturer n becomes aware of information n that reasonably suggests n one of its marketed devices n may have caused or contributed to a serious injury or death OR n malfunctioned and same or similar device would likely cause or contribute to serious injury or death upon if malfunction were to recur 4

5 Preamble statement likely Reporters do not need to assess the likelihood that a malfunction will recur. The fact that the malfunction occurred once leads to the presumption that the malfunction will recur. A malfunction is reportable if any one of the following is true: (1) The chance of a death or serious injury occurring as a result of a recurrence of the malfunction is not remote; 5

6 Draft Guidance likely n If malfunction causes death or serious injury once, it is presumed likely to do so q Subsequent malfunctions must be reported n Must file exemption to lift presumption q Based on investigation of subsequent malfunctions q FDA appears to abandon previous two year presumption guidance 6

7 Requirement to Investigate n Perennial problem sometimes difficult to obtain information, healthcare facility or clinician may be uncooperative n Draft guidance says q Level of effort should relate to nature and severity of the event, rather than just focusing on number of attempts n Many manufacturers have a procedure requiring three attempts q Good faith effort includes at least one written request q Record each attempt and response by reporter 7

8 Requirement to Investigate n Draft guidance recommends focus on q Patient involvement and outcome your ability to capture this information is part of good faith effort q If initial report is for a malfunction, but patient subsequently dies, supplemental report should be submitted for death 8

9 Requirement to Investigate n Draft guidance q Good faith effort does not require specific number of attempts one attempt should be in writing q Try to get the device back n If users do not cooperate, you must still analyze event cannot just close the file n Look at device history, manufacturing processes, similar events 9

10 Exemptions Are Becoming More Important n FDA s position (in warning letters and draft guidance) is that q Manufacturers and importer have duplicate requirement to report death or serious injuries need an exemption to have just one report q Manufacturer and contract manufacturer of the finished device have duplicate reporting requirements absent an exemption n Many firms have allocated responsibility by contract but have not requested exemptions for the nonreporter q This needs to change need a contract allocation and an exemption! 10

11 Delay in Surgery n If your device causes or contributes to a delay in surgery, is it a reportable event? q Maybe! n Draft guidance q Delay not automatically reportable q Need to gather details about impact on the patient s condition to support reporting decision 11

12 Routine Surgical Explants n Draft guidance - not reportable if implant has reached (or is near) its established life expectancy q Unless there is device-related death or serious injury associated with explantation / replacement 12

13 Labeled Incompatibility n Device A s labeling states it is not compatible with Device B n Physician uses them together adverse event n Reportable? q Yes if there is a patient serious injury or death because these are reportable even when caused by user error! q No if there is no patient adverse event but the devices do not work not a malfunction because labeling was not followed, so no malfunction report required 13

14 Diagnostic Devices n If diagnostic device failure indirectly serious injury or death reportable? n Draft guidance yes! 14

15 Difference of Medical Opinion n What is healthcare professionals at facility differ over whether malfunction occurred or device may have caused or contributed to serious injury or death? n Draft guidance says- q You must investigate and determine if information reasonably suggests malfunction / serious injury / death q Evaluate the differences in opinion and explain why you choose one over the other 15

16 Same Patient / Different Days n Draft guidance - same patient experiences adverse events on different days with same device report each as separate submission 16

17 Devices under Investigational Device Exemption (IDE) n Draft guidance q Device X is cleared or approved q Device X is being studied for a second intended use under an IDE q Adverse event occurs in the IDE study n Reportable? q Yes both MDR and IDE reporting requirements apply! 17

18 Foreign Events n Device X is exported under section 801(e) or 802 of the Food, Drug, and Cosmetic Act (so it is not cleared or approved for sale in the US) n Reportable event occurs in the EU n Reportable? q Draft guidance yes but we re going to exercise enforcement discretion q Excepts if a concern has arisen but we ll let you know in writing 18

19 Foreign Events n US manufacturer q Device under IDE study in US q Exported under 801(e) or 802 of the FDCA q Adverse event outside US n Reportable? q Draft guidance yes, but enforcement discretion q But it may be reportable to the IDE program 19

20 Foreign Manufacturer n Draft guidance hypothetical q Foreign manufacturer q US clearance or approval q Marketed outside US q Adverse event outside US n Reportable? q Draft guidance yes even if devices are tweaked to meet different standards outside US q Unless modification is directly involved 20

21 Foreign Manufacturer n Draft guidance hypothetical q Foreign manufacturer q No US clearance or approval, but IDE study q Marketed outside US q Adverse event outside US n Reportable? q Draft guidance no MDR report (might be reportable to IDE program) 21

22 Malfunction Caught Before Use n Draft guidance health care provider notices that device is malfunctioning and intervenes before patient harm can occur n Reportable? q Yes, if it could cause serious injury or death if malfunction were to recur n What if device malfunctions and alarms to alert users? q Draft guidance yes because alarm might not work or there might be no one present to respond 22

23 Sale of 510(k) n Draft guidance hypothetical- q Firm A manufacturers and distributes cleared device q Sells 510(k) to Firm B which takes over manufacture and distribution q Adverse event for device sold by Firm A n Who must report? q Firm A q Or firms could agree that Firm B will report but Firm A needs to apply for an exemption as well 23

24 IMPORTANT LINKS MDR Guidance Document - MDR Preamble Compliance Program Guidance Manual CDRH Learn emdr Draft Guidance utm_campaign=google2&utm_source=fdasearch&utm_medium=website&utm_term=mdr %20Guidance&utm_content=2 24

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