80 FR 50010 - Pilot Program for Medical Device Reporting on Malfunctions
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 159 (August 18, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 159 (August 18, 2015)
| Page Range | 50010-50013 | |
| FR Document | 2015-20309 |
[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)] [Notices] [Pages 50010-50013] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-20309] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-2918] Pilot Program for Medical Device Reporting on Malfunctions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is soliciting nominations for participation in a pilot program for the submission of medical device reports for malfunctions of class I devices and certain class II devices in summary format on a quarterly basis. Under the Medical Device Reporting on Malfunctions pilot program, FDA intends to work with manufacturers to identify candidates for the pilot program and intends to continue to accept nominations until candidates for the pilot program have been selected. DATES: FDA will begin accepting nominations for participation in the voluntary pilot program on September 1, 2015, and intends to continue to accept nominations until candidates for the pilot program have been selected. See section II for instructions on how to participate in the voluntary pilot program. FOR FURTHER INFORMATION CONTACT: William C. Maloney, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 3236, Silver Spring, MD 20993-0002, [email protected]. SUPPLEMENTARY INFORMATION: I. Background The Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85), amended section 519(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360i(a)), relating to the reporting of device malfunctions to FDA under part 803 (21 CFR part 803). Specifically, FDAAA amended the FD&C Act to require that medical device reports of malfunctions for class I devices and those class II devices that are not permanently implantable, life supporting, or life sustaining--with the exception of any type of class I or II device which FDA has, by notice, published in the Federal Register or by letter to the person who is the manufacturer or importer of the device, indicated should be subject to part 803 in order to protect the public health--be submitted in accordance with the criteria established by FDA (section 519(a)(1)(B)(ii) of the FD&C Act).\1\ The criteria must require the reports to be in summary form and made on a quarterly basis (section 519(a)(1)(B)(ii) of the FD&C Act). --------------------------------------------------------------------------- \1\ In light of section 1003(d) of the FD&C Act (21 U.S.C. 393(d)) and the Secretary of Health and Human Services' (the Secretary's) delegation to the Commissioner of Food and Drugs, statutory references to ``the Secretary'' have been changed to ``FDA'' or the ``Agency'' in this document. --------------------------------------------------------------------------- FDA is considering the development of malfunction reporting criteria for devices subject to section 519(a)(1)(B)(ii) of the FD&C Act. In the interim, FDA clarified that all manufacturers of class I devices and those class II devices that are not permanently implantable, life supporting, or life sustaining, must continue to report in full compliance with part 803 (76 FR 12743 at 12744, March 8, 2011). The malfunction reporting requirements for class III devices and those class II devices that are permanently implantable, life supporting, or life sustaining were not altered by FDAAA. Under the amended section 519(a) of the FD&C Act, device manufacturers are to continue to submit malfunction reports in accordance with part 803 for all class III devices and for those class II devices that are permanently implantable, life supporting, or life sustaining, unless FDA grants an exemption or variance from, or an alternative to, a requirement under such regulations under Sec. 803.19 (section 519(a)(1)(B)(i) of the FD&C Act). In addition, under section 519(a) of the FD&C Act, as amended by FDAAA, there is no change to the obligation for an importer to submit malfunction reports to the manufacturer in accordance with part 803 for devices that it imports into the United States (section 519(a)(1)(B)(iii) of the FD&C Act). FDA intends to use the information learned and experiences gained from the pilot program to develop the malfunction reporting criteria for devices subject to section 519(a)(1)(B)(ii) of the FD&C Act. II. Pilot Program for Medical Device Reporting (MDR) on Malfunctions FDA has developed this pilot program for manufacturers interested in submitting malfunction reports for certain devices in a summary format on a quarterly basis. This notice provides: [[Page 50011]] (1) The guiding principles underlying the pilot program, (2) the conditions for participation in the pilot program, (3) a description of the pilot program, (4) the eligibility criteria for the pilot program, (5) the procedures that FDA intends to follow in the pilot program, (6) the manufacturer notification process, (7) FDA's review process for the summary reports, (8) the duration of the pilot program, and (9) FDA's evaluation process for the pilot program. A. Guiding Principles The following basic principles underlie the Medical Device Reporting on Malfunctions pilot program described in this notice. FDA intends for these principles to create a common understanding between the manufacturer and FDA about the goals and parameters of this pilot program. 1. FDA is exploring a possible approach to summary reporting of device malfunctions on a quarterly basis under the pilot program (as illustrated in the case examples in this notice in section II.C. Description of the Program) that would allow FDA to collect sufficient detail to effectively monitor the devices subject to section 519(a)(1)(B)(ii) of the FD&C Act and protect the public health. 2. The data received in this pilot should contain details sufficient to understand the device-related malfunctions. A narrative text should be provided to include a summary of the malfunction events, the results of the manufacturer's investigation of the reported malfunctions, including the type of any remedial action taken or an explanation of why remedial action was not taken, and any additional information that would be helpful to understand how the manufacturer addressed the malfunctions summarized in the report. 3. As the summary information collected under this pilot represents a subset of the detailed information collected under Sec. 803.52, FDA intends to use the existing electronic Medical Device Reporting (eMDR) infrastructure for the summary reports. 4. All summary MDR reports \2\ will appear in the Manufacturer and User Facility Device Experience (MAUDE) database, which is publically available. --------------------------------------------------------------------------- \2\ Any information in the report that is protected from public disclosure under the Freedom of Information Act (FOIA) will be redacted prior to the release of the report. --------------------------------------------------------------------------- B. Conditions 1. Under Sec. 803.19, manufacturers who are accepted into the program will be granted an exemption or variance from, or alternative to, the reporting requirements under Sec. Sec. 803.50(a) and 803.52 for those malfunction events associated with the devices selected for the pilot. Other reportable events involving the devices selected for the pilot must be reported to FDA within the mandatory 30-calendar day timeframe on Form FDA 3500A, as required by Sec. Sec. 803.50(a) and 803.52, or within the 5-work day timeframe as required by Sec. 803.53. Additional information and instructions will be provided to manufacturers accepted into the pilot. 2. A candidate is not precluded from withdrawing from the pilot program at any time and returning to the individual reporting requirements of Sec. Sec. 803.50(a) and 803.52. 3. Due to FDA resource issues, FDA intends to limit the pilot program to no more than nine (9) candidates. 4. At its discretion, FDA may withdraw a manufacturer from the pilot program, for reasons including, but not limited to, any violations of the FD&C Act, failure to follow the instructions of the pilot program, or if FDA obtains information after the manufacturer is accepted to the pilot program that the manufacturer is not an appropriate candidate for the program as described in this notice in section II.D. Appropriate Candidates. Withdrawal from the pilot program will result in a return to the individual reporting requirements of Sec. Sec. 803.50(a) and 803.52. 5. At its discretion, FDA may modify specific details regarding the pilot if needed. Any such changes will be communicated directly to the candidates of the pilot program. C. Description of the Program Candidates of the pilot program will submit Form FDA 3500A reports in electronic reporting format on a quarterly basis. For purposes of the pilot, ``quarterly basis'' is defined as a three (3) month period. Each submission should represent a summary of malfunction events received for a unique device problem code or set of codes within the quarterly timeframe, and for a particular device model number and/or catalog number. Device malfunctions that are summarized in one report should not be duplicated in any other submissions within the same quarterly timeframe. Summary reports should include the following information collected on Form FDA 3500A in electronic format: SECTION B.5: Describe Event or Problem--The device event narrative should include a description of the nature of the events (being as specific as possible); and if available, a range of patient age and weight, and a breakdown of patient gender. The first sentence of the device event narrative should include the following sentence: ``This report summarizesXXX malfunction events'' where XXX is replaced by the number of malfunction events being summarized. SECTION D.2 and D.2.b: Common Device Name and Procode--Enter the common name of the device and the product code. SECTION D.3: Manufacturer Name, City and State--Enter the manufacturer name, city and state where the manufacturer is located. SECTION D.4: Device Identification--Enter the model or catalog number for the device being summarized in the MDR report. SECTION G.1: Contact Office (and Manufacturing Site for Devices)-- Enter the name and address of the manufacturer reporting site [contact office], including contact name for the report submitted. Enter the name and address of the manufacturing site for the device, if different from the contact office. SECTION G.2: Phone Number--Enter the phone number for the contact office. SECTION H.1: Type of Reportable Event--Check ``Malfunction'' in this box. SECTION H.6: Event Problem and Evaluation Codes--Enter the device problem code(s), including any codes received from a user facility or importer report provided in Section F.10 of Form FDA 3500A. Enter ``9999'' as the first device problem code to identify the report as a summary malfunction report. Enter the evaluation code(s) for the categories of method, results, and conclusions. Enter a conclusion code(s) even if the device was not evaluated. SECTION H.10: Additional Manufacturer Narrative--Provide a summary of the results of your investigation of the reported malfunctions, including the type of any remedial action taken or an explanation of why remedial action was not taken, and any additional information that would be helpful to understand how you addressed the malfunction events summarized in the report. Also enter a breakdown of the malfunction events summarized in the report, including the number of devices that were returned to you; the number of devices that were labeled for single use (if any); and the number of devices that were reprocessed and re-used (if any). Note: All reportable adverse events which result in a serious injury or death; and/or necessitate remedial action to prevent an unreasonable risk of substantial harm to the public health, are excluded from this pilot program. In addition, for reference here is the [[Page 50012]] link to the on-line version of the Form FDA 3500A: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM048334.pdf. Case Examples: The following examples are meant to illustrate the format for how malfunction reports submitted under this pilot will be captured. All of these examples are for class I devices and those class II devices that are not permanently implantable, life supporting, or life sustaining. These examples do not address interpretation of these reportable events. Case Scenario #1: Multiple malfunction reports for the same device problem. A manufacturer receives 50 similar reports within the quarterly timeframe indicating that model XYZ pump experienced an air detected set alarm, which interrupted delivery. The alarms may have been a false alarm. These events were received from various sources. Of the 50 adverse events, 46 did not involve patients, and 4 involved patients with no reported injuries or deaths. None of these events necessitate remedial action to prevent an unreasonable risk of substantial harm to the public health. The XYZ pumps were recently retrofitted with a new user interface software model V.2.04.12. Report for Case #1: A single summary MDR report is to be submitted to FDA through eMDR:B.5: This report summarizes 50 malfunction events. A review of the events indicated that model XYZ pump experienced an air detected set alarm, which interrupted delivery. The alarms may have been a false alarm. These reports were received from various sources. Of the 50 events, 46 did not involve patients, and 4 involved patients with no patient consequences. The four patients ranged from 25-32 years of age and 130-250 lbs. Of the reported patients, one was male and three were female. The XYZ pumps were recently retrofitted with a new user interface software model V.2.04.12.D.2: Infusion Pump D.2.b: FRN D.3: ABC Company, 123 Baker Street, Anywhere, MD, USA D.4: Model XYZ G.1: Mr. X, ABC company, 123 Baker Street, Anywhere, MD, USA G.2: 301-555-0001 H.1: Malfunction H.6: Device Codes: 9999 (Summary Malfunction); 1008 (Air Leak) H.6: Manufacturer Method Codes: 10 (Actual Device Evaluated); 38 (Visual Inspection) H.6: Manufacturer Results Code: 549 (Air pump assembly) H.6: Manufacturer Evaluation Conclusion Codes: 52 (Device was out of calibration) H.10: For 40 of the 50 reported events, the devices were returned to ABC, and their operating condition was confirmed by service. The cause of the malfunction was determined to be a faulty pump head module. To correct the condition, the pump head modules were replaced. Case Scenario #2: Multiple malfunction reports that have two device problems: A manufacturer receives 100 malfunction reports within the quarterly timeframe that include two types of device malfunctions that are related to a specific model (XYZ, Version 2) of a powered AC bed: (1) 75 events involve a broken weld near where the motor attaches; and (2) 55 events involve a screw that attaches the bed rail to the mounting bracket on the bed, which snapped. Some of the events involve both types of device malfunctions. None of the events involve patients. None of the events necessitate remedial action to prevent an unreasonable risk of substantial harm to the public health. Reports for Case #2: Under this pilot, a unique device problem code or set of codes for a particular device model number and/or catalog number that are summarized in one report should not be duplicated in any other submissions within the same quarterly timeframe. As a result, there are three categories of reports for this scenario--(1) 45 events that involve broken welds only; (2) 25 events that involve broken screws only; and (3) 30 events that involve both broken welds and broken screws. Therefore, three summary reports will need to be submitted to FDA through eMDR. Report #1: B.5: This report summarizes 45 malfunction events. A review of the events indicated that model XYZ experienced broken welds near where the motor attaches to the powered AC beds. No patients were involved.D.2: AC Powered Beds D.2.b: FNL D.3: ABC company, 123 Baker Street, Anywhere, MD, USA D.4: Model XYZ G.1: Mr. X, ABC Company, 123 Baker Street, Anywhere, MD, USA G.2: 301-555-0001 H.1: Malfunction H.6: Device Codes: 9999 (Summary Malfunction); 1069 (Break); 3195 (Weld) H.6: Manufacturer Method Codes: 10 (Actual Device Evaluated); 38 (Visual Inspection) H.6: Manufacturer Results Code: 170 (Manufacturing process problem) H.6: Manufacturer Evaluation Conclusion Codes: 12 (Design deficiency) H.10: To correct the condition, the beds were taken out of service. Report #2: B.5: This report summarizes 25 malfunction events. A review of the events indicated that a screw that attaches the bed rail to the mounting bracket on the bed is snapping on model XYZ. No patients were involved.D.2: AC Powered Beds D.2.b: FNL D.3: ABC company, 123 Baker Street, Anywhere, MD, USA D.4: Model XYZ G.1: Mr. X, ABC Company, 123 Baker Street, Anywhere, MD, USA G.2: 301-555-0001 H.1: Malfunction H.6: Device Codes: 9999 (Summary Malfunction); 1069 (Break); 568 (Screw) H.6: Manufacturer Method Codes: 10 (Actual Device Evaluated); 38 (Visual Inspection) H.6: Manufacturer Results Code: 170 (Manufacturing process problem) H.6: Manufacturer Evaluation Conclusion Codes: 12 (Design deficiency) H.10: To correct the condition, the beds were taken out of service temporarily. A technician was dispatched to replace the screw. Load testing was applied to verify bed rail performance. Report #3: B.5: This report summarizes 30 malfunction events. A review of the events indicated that a screw that attaches the bed rail to the mounting bracket on the AC powered bed failed causing the bed rail to detach and collide with the beam near where the motor attaches. The force of impact caused a broken weld to form near the motor attachment on the AC powered bed. No patients were involved.D.2: AC Powered Beds D.2.b: FNL D.3: ABC Company, 123 Baker Street, Anywhere, MD, USA D.4: Model XYZ G.1: Mr. X., ABC Company, 123 Baker Street, Anywhere, MD, USA G.2: 301-555-0001 H.1: Malfunction H.6: Device Codes: 9999 (Summary Malfunction); 1069 (Break); 3195 (Screw); 568 (Weld) H.6: Manufacturer Method Codes: 10 (Actual Device Evaluated); 38 (Visual Inspection) H.6: Manufacturer Results Code: 170 (Manufacturing process problem) [[Page 50013]] H.6: Manufacturer Evaluation Conclusion Codes: 12 (Design deficiency) H.10: To correct the condition, the beds were taken out of service. Technicians have examined the beds and have opened up a Corrective and Preventive Action (CAPA) to address the design issue. D. Appropriate Candidates Appropriate candidates for the pilot program are manufacturers who: 1. Are currently submitting reports to FDA using the paper Form FDA 3500A or the electronic MDR (eMDR) format. 2. Manufacture class I devices and/or those class II devices that are not permanently implantable, life supporting, or life sustaining. 3. Currently use or are willing to use eMDR to submit summary malfunction reports to the FDA during the pilot period. 4. Are in compliance with the Medical Device Reporting regulation in 21 CFR part 803. E. Procedures 1. Nomination A manufacturer of class I devices and those class II devices that are not permanently implantable, life supporting, or life sustaining may nominate themselves for participation in the pilot program by submitting a nomination to [email protected]. FDA intends to acknowledge receipt of nominations via return email. The following information will assist FDA in processing and responding to nominations: Name of manufacturer Registration number Contact name, address, phone number, and email address Model or catalog number for the device(s) that you are requesting to include in the pilot, and Product classification code for the device(s) that you are requesting to include in the pilot. You may access the Product Classification Code database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm. 2. FDA Consideration Acceptance of nominations will start 2 weeks following the publication date of this Federal Register notice. Because only a limited number of candidates are needed, FDA will use its discretion in choosing candidates based on the eligibility criteria in this Federal Register notice in section II.D. Appropriate Candidates, the needs of the pilot to include a diversity of manufacturers with regard to device type (including in vitro diagnostic devices), and expected number of malfunction events. FDA may contact the manufacturer to request supplemental information if this information is needed in order to complete our review of the request. The manufacturer must provide the supplemental information within 15 days of FDA's request; otherwise, the Agency will consider the nomination withdrawn. F. Manufacturer Notification FDA intends to notify manufacturers who are selected for this pilot program within 45 days from receiving their nomination or any supplemental information requested by FDA. Once FDA has selected the candidates for this pilot, FDA will notify subsequent applicants by email that the nomination period has closed. G. FDA Review All reports received under the pilot program will be reviewed and processed in the same manner as individual medical device reports that are submitted under part 803. A version of the report releasable under FOIA will be accessible through the public MAUDE database. H. Duration of the Pilot FDA intends for the pilot program to run for 2 calendar quarters for each candidate and will continue until the 2 calendar quarters have been completed for all candidates. At its discretion, FDA may terminate the pilot program before the close of this period, or FDA may extend the pilot program beyond the 2 calendar quarters. The decision to terminate or extend the pilot will be announced in the Federal Register. I. Evaluation FDA intends to evaluate all information and feedback received from the candidates and to use the information and experiences gained from the pilot program to develop criteria for summary reporting on a quarterly basis for devices subject to section 519(a)(1)(B)(ii) of the FD&C Act. III. Paper Reduction Act of 1995 This notice refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501- 3520). The collections of information in 21 CFR part 803 have been approved under OMB control number 0910-0437; the collections of information in Form FDA 3500A have been approved under OMB control number 0910-0291. Dated: August 12, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-20309 Filed 8-17-15; 8:45 am] BILLING CODE 4164-01-P
![50010 Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices
reflects recent developments in Dated: August 12, 2015. published in the Federal Register or by
scientific information that pertain to Leslie Kux, letter to the person who is the
drugs being developed for the treatment Associate Commissioner for Policy. manufacturer or importer of the device,
of uncomplicated gonorrhea. [FR Doc. 2015–20306 Filed 8–17–15; 8:45 am] indicated should be subject to part 803
in order to protect the public health—
Issuance of this guidance fulfills a BILLING CODE 4164–01–P
be submitted in accordance with the
portion of the requirements of Title VIII,
criteria established by FDA (section
section 804, of the Food and Drug 519(a)(1)(B)(ii) of the FD&C Act).1 The
Administration Safety and Innovation DEPARTMENT OF HEALTH AND
HUMAN SERVICES criteria must require the reports to be in
Act (Pub. L. 112–144), which requires summary form and made on a quarterly
FDA to review and, as appropriate, Food and Drug Administration basis (section 519(a)(1)(B)(ii) of the
revise not fewer than three guidance FD&C Act).
documents per year for the conduct of [Docket No. FDA–2015–N–2918]
FDA is considering the development
clinical trials with respect to Pilot Program for Medical Device of malfunction reporting criteria for
antibacterial and antifungal drugs. Reporting on Malfunctions devices subject to section 519(a)(1)(B)(ii)
This guidance is being issued of the FD&C Act. In the interim, FDA
consistent with FDA’s good guidance AGENCY: Food and Drug Administration, clarified that all manufacturers of class
HHS. I devices and those class II devices that
practices regulation (21 CFR 10.115).
ACTION: Notice. are not permanently implantable, life
The guidance represents the current
supporting, or life sustaining, must
thinking of FDA on developing drugs for SUMMARY: The Food and Drug continue to report in full compliance
the treatment of uncomplicated Administration (FDA) is soliciting with part 803 (76 FR 12743 at 12744,
gonorrhea. It does not establish any nominations for participation in a pilot March 8, 2011).
rights for any person and is not binding program for the submission of medical The malfunction reporting
on FDA or the public. You can use an device reports for malfunctions of class requirements for class III devices and
alternative approach if it satisfies the I devices and certain class II devices in those class II devices that are
requirements of the applicable statutes summary format on a quarterly basis. permanently implantable, life
and regulations. Under the Medical Device Reporting on supporting, or life sustaining were not
Malfunctions pilot program, FDA altered by FDAAA. Under the amended
II. The Paperwork Reduction Act of
intends to work with manufacturers to section 519(a) of the FD&C Act, device
1995 identify candidates for the pilot program manufacturers are to continue to submit
This guidance refers to previously and intends to continue to accept malfunction reports in accordance with
approved collections of information that nominations until candidates for the part 803 for all class III devices and for
are subject to review by the Office of pilot program have been selected. those class II devices that are
Management and Budget (OMB) under DATES: FDA will begin accepting permanently implantable, life
nominations for participation in the supporting, or life sustaining, unless
the Paperwork Reduction Act of 1995
voluntary pilot program on September FDA grants an exemption or variance
(44 U.S.C. 3501–3520). The collections
1, 2015, and intends to continue to from, or an alternative to, a requirement
of information in 21 CFR parts 312 and
accept nominations until candidates for under such regulations under § 803.19
314 have been approved under OMB (section 519(a)(1)(B)(i) of the FD&C Act).
control numbers 0910–0014 and 0910– the pilot program have been selected.
See section II for instructions on how to In addition, under section 519(a) of
0001, respectively. the FD&C Act, as amended by FDAAA,
participate in the voluntary pilot
III. Comments program. there is no change to the obligation for
an importer to submit malfunction
FOR FURTHER INFORMATION CONTACT:
Interested persons may submit either reports to the manufacturer in
William C. Maloney, Center for Devices accordance with part 803 for devices
electronic comments regarding this
and Radiological Health, 10903 New that it imports into the United States
document to http://www.regulations.gov
Hampshire Ave., Bldg. 66, Rm. 3236, (section 519(a)(1)(B)(iii) of the FD&C
or written comments to the Division of
Silver Spring, MD 20993–0002, Act).
Dockets Management (see ADDRESSES). It 227pilot@fda.hhs.gov.
is only necessary to send one set of FDA intends to use the information
SUPPLEMENTARY INFORMATION: learned and experiences gained from the
comments. Identify comments with the
docket number found in brackets in the I. Background pilot program to develop the
heading of this document. Received malfunction reporting criteria for
The Food and Drug Administration devices subject to section 519(a)(1)(B)(ii)
comments may be seen in the Division Amendments Act of 2007 (FDAAA) of the FD&C Act.
of Dockets Management between 9 a.m. (Pub. L. 110–85), amended section
and 4 p.m., Monday through Friday and 519(a) of the Federal Food, Drug, and II. Pilot Program for Medical Device
will be posted to the docket at http:// Cosmetic Act (the FD&C Act) (21 U.S.C. Reporting (MDR) on Malfunctions
www.regulations.gov. 360i(a)), relating to the reporting of FDA has developed this pilot program
device malfunctions to FDA under part for manufacturers interested in
IV. Electronic Access
803 (21 CFR part 803). Specifically, submitting malfunction reports for
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Persons with access to the Internet FDAAA amended the FD&C Act to certain devices in a summary format on
may obtain the document at either require that medical device reports of a quarterly basis. This notice provides:
http://www.fda.gov/Drugs/ malfunctions for class I devices and
GuidanceCompliance/ those class II devices that are not 1 In light of section 1003(d) of the FD&C Act (21
permanently implantable, life U.S.C. 393(d)) and the Secretary of Health and
RegulatoryInformation/Guidances/ Human Services’ (the Secretary’s) delegation to the
default.htm or http:// supporting, or life sustaining—with the Commissioner of Food and Drugs, statutory
www.regulations.gov. exception of any type of class I or II references to ‘‘the Secretary’’ have been changed to
device which FDA has, by notice, ‘‘FDA’’ or the ‘‘Agency’’ in this document.
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![Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices 50011
(1) The guiding principles underlying requirements under §§ 803.50(a) and breakdown of patient gender. The first
the pilot program, (2) the conditions for 803.52 for those malfunction events sentence of the device event narrative
participation in the pilot program, (3) a associated with the devices selected for should include the following sentence:
description of the pilot program, (4) the the pilot. Other reportable events ‘‘This report summarizes <NOE> XXX
eligibility criteria for the pilot program, involving the devices selected for the </NOE> malfunction events’’ where
(5) the procedures that FDA intends to pilot must be reported to FDA within XXX is replaced by the number of
follow in the pilot program, (6) the the mandatory 30-calendar day malfunction events being summarized.
manufacturer notification process, (7) timeframe on Form FDA 3500A, as SECTION D.2 and D.2.b: Common
FDA’s review process for the summary required by §§ 803.50(a) and 803.52, or Device Name and Procode—Enter the
reports, (8) the duration of the pilot within the 5-work day timeframe as common name of the device and the
program, and (9) FDA’s evaluation required by § 803.53. Additional product code.
process for the pilot program. information and instructions will be SECTION D.3: Manufacturer Name,
provided to manufacturers accepted into City and State—Enter the manufacturer
A. Guiding Principles name, city and state where the
the pilot.
The following basic principles 2. A candidate is not precluded from manufacturer is located.
underlie the Medical Device Reporting withdrawing from the pilot program at SECTION D.4: Device Identification—
on Malfunctions pilot program any time and returning to the individual Enter the model or catalog number for
described in this notice. FDA intends reporting requirements of §§ 803.50(a) the device being summarized in the
for these principles to create a common and 803.52. MDR report.
understanding between the 3. Due to FDA resource issues, FDA SECTION G.1: Contact Office (and
manufacturer and FDA about the goals intends to limit the pilot program to no Manufacturing Site for Devices)—Enter
and parameters of this pilot program. more than nine (9) candidates. the name and address of the
1. FDA is exploring a possible 4. At its discretion, FDA may manufacturer reporting site [contact
approach to summary reporting of withdraw a manufacturer from the pilot office], including contact name for the
device malfunctions on a quarterly basis program, for reasons including, but not report submitted. Enter the name and
under the pilot program (as illustrated limited to, any violations of the FD&C address of the manufacturing site for the
in the case examples in this notice in Act, failure to follow the instructions of device, if different from the contact
section II.C. Description of the Program) the pilot program, or if FDA obtains office.
that would allow FDA to collect information after the manufacturer is SECTION G.2: Phone Number—Enter
sufficient detail to effectively monitor accepted to the pilot program that the the phone number for the contact office.
the devices subject to section manufacturer is not an appropriate SECTION H.1: Type of Reportable
519(a)(1)(B)(ii) of the FD&C Act and candidate for the program as described Event—Check ‘‘Malfunction’’ in this
protect the public health. in this notice in section II.D. box.
2. The data received in this pilot Appropriate Candidates. Withdrawal SECTION H.6: Event Problem and
should contain details sufficient to from the pilot program will result in a Evaluation Codes—Enter the device
understand the device-related return to the individual reporting problem code(s), including any codes
malfunctions. A narrative text should be requirements of §§ 803.50(a) and 803.52. received from a user facility or importer
provided to include a summary of the 5. At its discretion, FDA may modify report provided in Section F.10 of Form
malfunction events, the results of the specific details regarding the pilot if FDA 3500A. Enter ‘‘9999’’ as the first
manufacturer’s investigation of the needed. Any such changes will be device problem code to identify the
reported malfunctions, including the communicated directly to the report as a summary malfunction report.
type of any remedial action taken or an candidates of the pilot program. Enter the evaluation code(s) for the
explanation of why remedial action was categories of method, results, and
not taken, and any additional C. Description of the Program conclusions. Enter a conclusion code(s)
information that would be helpful to Candidates of the pilot program will even if the device was not evaluated.
understand how the manufacturer submit Form FDA 3500A reports in SECTION H.10: Additional
addressed the malfunctions summarized electronic reporting format on a Manufacturer Narrative—Provide a
in the report. quarterly basis. For purposes of the summary of the results of your
3. As the summary information pilot, ‘‘quarterly basis’’ is defined as a investigation of the reported
collected under this pilot represents a three (3) month period. Each submission malfunctions, including the type of any
subset of the detailed information should represent a summary of remedial action taken or an explanation
collected under § 803.52, FDA intends malfunction events received for a of why remedial action was not taken,
to use the existing electronic Medical unique device problem code or set of and any additional information that
Device Reporting (eMDR) infrastructure codes within the quarterly timeframe, would be helpful to understand how
for the summary reports. and for a particular device model you addressed the malfunction events
4. All summary MDR reports 2 will number and/or catalog number. Device summarized in the report. Also enter a
appear in the Manufacturer and User malfunctions that are summarized in breakdown of the malfunction events
Facility Device Experience (MAUDE) one report should not be duplicated in summarized in the report, including the
database, which is publically available. any other submissions within the same number of devices that were returned to
B. Conditions quarterly timeframe. you; the number of devices that were
Summary reports should include the
asabaliauskas on DSK5VPTVN1PROD with NOTICES
labeled for single use (if any); and the
1. Under § 803.19, manufacturers who following information collected on number of devices that were
are accepted into the program will be Form FDA 3500A in electronic format: reprocessed and re-used (if any).
granted an exemption or variance from, SECTION B.5: Describe Event or
or alternative to, the reporting Note: All reportable adverse events which
Problem—The device event narrative result in a serious injury or death; and/or
2 Any information in the report that is protected
should include a description of the necessitate remedial action to prevent an
from public disclosure under the Freedom of
nature of the events (being as specific as unreasonable risk of substantial harm to the
Information Act (FOIA) will be redacted prior to the possible); and if available, a range of public health, are excluded from this pilot
release of the report. patient age and weight, and a program. In addition, for reference here is the
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![Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices 50013
• H.6: Manufacturer Evaluation type (including in vitro diagnostic been approved under OMB control
Conclusion Codes: 12 (Design devices), and expected number of number 0910–0291.
deficiency) malfunction events. FDA may contact Dated: August 12, 2015.
• H.10: To correct the condition, the the manufacturer to request Leslie Kux,
beds were taken out of service. supplemental information if this
Associate Commissioner for Policy.
Technicians have examined the beds information is needed in order to
[FR Doc. 2015–20309 Filed 8–17–15; 8:45 am]
and have opened up a Corrective and complete our review of the request. The
Preventive Action (CAPA) to address manufacturer must provide the BILLING CODE 4164–01–P
the design issue. supplemental information within 15
days of FDA’s request; otherwise, the
D. Appropriate Candidates DEPARTMENT OF HEALTH AND
Agency will consider the nomination
Appropriate candidates for the pilot HUMAN SERVICES
withdrawn.
program are manufacturers who: Food and Drug Administration
1. Are currently submitting reports to F. Manufacturer Notification
FDA using the paper Form FDA 3500A FDA intends to notify manufacturers
or the electronic MDR (eMDR) format. [Docket No. FDA–2014–D–0903]
who are selected for this pilot program
2. Manufacture class I devices and/or within 45 days from receiving their Providing Submissions in Electronic
those class II devices that are not nomination or any supplemental Format—Postmarketing Safety Reports
permanently implantable, life information requested by FDA. Once for Vaccines; Guidance for Industry;
supporting, or life sustaining. FDA has selected the candidates for this Availability
3. Currently use or are willing to use pilot, FDA will notify subsequent
eMDR to submit summary malfunction applicants by email that the nomination AGENCY: Food and Drug Administration,
reports to the FDA during the pilot period has closed. HHS.
period. ACTION: Notice.
4. Are in compliance with the G. FDA Review
Medical Device Reporting regulation in All reports received under the pilot SUMMARY: The Food and Drug
21 CFR part 803. program will be reviewed and processed Administration (FDA or Agency) is
E. Procedures in the same manner as individual announcing the availability of a
medical device reports that are document entitled ‘‘Providing
1. Nomination submitted under part 803. A version of Submissions in Electronic Format—
A manufacturer of class I devices and the report releasable under FOIA will be Postmarketing Safety Reports for
those class II devices that are not accessible through the public MAUDE Vaccines; Guidance for Industry.’’ The
permanently implantable, life database. guidance document provides
supporting, or life sustaining may information and recommendations
H. Duration of the Pilot pertaining to the electronic submission
nominate themselves for participation
in the pilot program by submitting a FDA intends for the pilot program to of postmarketing safety reports
nomination to 227pilot@fda.hhs.gov. run for 2 calendar quarters for each involving vaccine products marketed for
FDA intends to acknowledge receipt of candidate and will continue until the 2 human use with approved biologics
nominations via return email. The calendar quarters have been completed license applications (BLAs), including
following information will assist FDA in for all candidates. At its discretion, FDA individual case safety reports (ICSRs)
processing and responding to may terminate the pilot program before and attachments to ICSRs (ICSR
nominations: the close of this period, or FDA may attachments), into the Vaccine Adverse
• Name of manufacturer extend the pilot program beyond the 2 Event Reporting System (VAERS).
• Registration number calendar quarters. The decision to VAERS is a national vaccine safety
• Contact name, address, phone terminate or extend the pilot will be surveillance program that is co-
number, and email address announced in the Federal Register. sponsored by the Centers for Disease
• Model or catalog number for the Control and Prevention (CDC) and FDA.
I. Evaluation FDA published in the Federal Register
device(s) that you are requesting to
include in the pilot, and FDA intends to evaluate all a final rule requiring that certain
• Product classification code for the information and feedback received from postmarketing safety reports for human
device(s) that you are requesting to the candidates and to use the drug and biological products, including
include in the pilot. You may access the information and experiences gained vaccines, be submitted to FDA in an
Product Classification Code database at from the pilot program to develop electronic format that the Agency can
http://www.accessdata.fda.gov/scripts/ criteria for summary reporting on a process, review, and archive. The
cdrh/cfdocs/cfPCD/classification.cfm. quarterly basis for devices subject to guidance is intended to help applicants
section 519(a)(1)(B)(ii) of the FD&C Act. required to submit postmarketing safety
2. FDA Consideration reports involving vaccine products to
III. Paper Reduction Act of 1995 comply with the final rule. The
Acceptance of nominations will start
2 weeks following the publication date This notice refers to previously guidance announced in this notice
of this Federal Register notice. Because approved collections of information that finalizes the draft guidance of the same
asabaliauskas on DSK5VPTVN1PROD with NOTICES
only a limited number of candidates are are subject to review by the Office of title, dated July 2014, and supersedes
needed, FDA will use its discretion in Management and Budget (OMB) under the document entitled ‘‘Guidance for
choosing candidates based on the the Paperwork Reduction Act of 1995 Industry: How to Complete the Vaccine
eligibility criteria in this Federal (44 U.S.C. 3501–3520). The collections Adverse Event Report System Form
Register notice in section II.D. of information in 21 CFR part 803 have (VAERS–1)’’ dated September 1998.
Appropriate Candidates, the needs of been approved under OMB control DATES: Submit either electronic or
the pilot to include a diversity of number 0910–0437; the collections of written comments on Agency guidances
manufacturers with regard to device information in Form FDA 3500A have at any time.
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Document Created: 2015-12-15 12:05:00
Document Modified: 2015-12-15 12:05:00
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | FDA will begin accepting nominations for participation in the voluntary pilot program on September 1, 2015, and intends to continue to accept nominations until candidates for the pilot program have been selected. See section II for instructions on how to participate in the voluntary pilot program. | |
| Contact | William C. Maloney, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 3236, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 50010 |
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