Complaint Handling Medical Device Reporting May 19, 2016 Rita Harden, Director Customer Relations & Regulatory Reporting

2Presentation Title Here.Version #2 March 2016  FDA requires that manufacturers shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit (21 CFR Part ).  Complaint handling is just a portion of the requirements from 820, to ensure that finished devices are safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act.  What is a Complaint?  Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution Complaint Handling

3Presentation Title Here.Version #2 March 2016 Complaint Handling  Potential Complaint Sources:  Call centers  Clinical studies  Distributors  Employees, contractors, manufacturing reps  Health Care professionals  Journal articles  Litigation and legal claims  Marketing surveys  News media Let’s take a look at case – “AM”  Patients, consumers  Post marketing studies  Regulatory Agencies  Service or repair requests  Trade shows  Training seminars and meetings  Websites and social media  Family and friends

4Presentation Title Here.Version #2 March 2016  21 CFR Complaint Files provides details of the requirements;  Process all complaints in a uniform and timely manner  Document oral complaints upon receipt  Evaluate to determine whether the complaint represents an Medical Device Report which is required to be reported under Part 803  Review and evaluate to determine whether an investigation is necessary.  If no investigation is made, maintain a record that includes that decision and the name of the individual responsible for that decision.  Maintain a record of the investigation by the formally designated unit. Complaint Handling

5Presentation Title Here.Version #2 March 2016  The investigation record should include the following:  Name of the device  Date complaint was received  UDI, UPC, or any other device identification and control numbers  Name, address, and phone number of complainant  Nature and details of the complaint  Dates and results of the investigation  Any corrective action taken  Any reply to the complainant Complaint Handling

6Presentation Title Here.Version #2 March 2016  Complaints that must be reported under Part 803 shall be promptly reviewed, evaluated, and investigated.  Maintain in a separate portion of the complaint file or otherwise clearly identify it.  In addition to investigation record, the file also needs to contain a determination of:  Whether the device failed to meet performance specifications  Whether the device was being used for treatment or diagnosis  The relationship, if any, of the device to the reported incident or adverse event.  Investigated complaint(s) and the record(s) of investigation need to be accessible to the manufacturing establishment if the designated complaint unit is separate from the manufacturing site. Complaint Handling

7Presentation Title Here.Version #2 March 2016  FDA has specific requirements for device user facilities, manufacturers, importers, and distributors relative to Medical Device Reporting (21 CFR Part 803).  These reports help FDA to protect the public health by helping to ensure that devices are not adulterated or misbranded and are safe and effective for their intended use. Medical Device Reporting

8Presentation Title Here.Version #2 March 2016  Who must submit?  Manufacturers & Importers  Must report deaths and serious injuries that your device has or may have caused or contributed to and certain device malfunctions  User Facilities  Must report deaths to the FDA & Manufacturers and serious injuries to the manufacturer  Establish and maintain adverse event files  Distributors must maintain records (files) of incidents, but you are not required to report these incidents. Medical Device Reporting

9Presentation Title Here.Version #2 March 2016  What is an MDR reportable event?  An event that manufacturers or importers become 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 device or 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.  Let’s take a look at the following definitions:  Become aware  Caused or contributed to  Serious injury  Malfunction Medical Device Reporting

10Presentation Title Here.Version #2 March 2016  Become aware – means that an employee of the entity required to report has acquired information that reasonably suggests a reportable event has occurred.  Caused or contributed to – means that a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury, including events occurring as a result of: (1) Failure; (2) Malfunction; (3) Improper or inadequate design; (4) Manufacture (5) Labeling; or (6) User Error. Medical Device Reporting

11Presentation Title Here.Version #2 March 2016  Serious Injury - means an injury or illness that is (1)life-threatening, (2)Results in permanent impairment of a body function or permanent damage to a body structure, or (3)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.  Malfunction – means 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. The intended performance of a device refers to the intended use for which the device is labeled or marketed. Medical Device Reporting

12Presentation Title Here.Version #2 March 2016 Medical Device Reporting ReporterWhat to ReportWhereWhen Manufacturer Deaths, Serious Injuries, Malfunction FDAWithin 30 calendar days Events that require remedial action to prevent an unreasonable risk of substantial harm FDAWithin 5 working days Supplements (Follow-up Reports FDAWithin 1 month User Facility Deaths FDA and Mfr.Within 10 working days Serious Injury Mfr. (FDA if unknown) Within 10 working days Importer Deaths & Serious Injuries FDA and Mfr.Within 30 calendar days Malfunctions Mfr.Within 30 calendar days

13Presentation Title Here.Version #2 March 2016  As of August 14, 2015, all Medical Device Reports are required to be filed electronically via eMDR.  eMDRs can be submitted through your electronic complaint software system or the eSubmitter software.  Insure that you receive all 3 acknowledgements and your submission has passed.  Reports are entered into the Manufacturer and User Facility Device Experience (MAUDE) database.  Event reports are analyzed. FDA may follow-up requesting additional information, conduct an investigation, issue a public health advisory/safety alert. Medical Device Reporting

14Presentation Title Here.Version #2 March 2016 Let’s take a look at case – “AM” Questions? THANK YOU! Complaint Handling & Medical Device Reporting