FORM FDA 3500A SUPPLEMENT (4/16) – FORM INSTRUCTIONS Page 1 of 15 PSC Publishing Services (301) 443-6740 EF GENERAL INSTRUCTIONS (Continued)
Total Page：16
File Type：pdf, Size：1020Kb
GENERAL INSTRUCTIONS – for Form FDA 3500A MedWatch (for Mandatory reporting) • All entries should be typed or printed in a font no Subject Device is: Manufacturer is: smaller than 8 point. Original Equipment Manufacturer Single Use Device • Complete all sections that apply. If information is (OEM) unknown, not available or does not apply, the section Original Equipment Manufacturer Device designed to be reused should be left blank. (OEM) • Dates should be entered as dd-mmm-yyyy (e.g., Single Use Device, reprocessed Reprocessor October 12, 2016 = 12 Oct 2016). If exact dates are for reuse unknown, provide the best estimate. Single Use Device, reprocessed Hospital or Health Care Facility • For narrative entries, if the fields do not provide by Hospital or Health Care Facility adequate space, attach an additional page(s). The following specific information is to be incorporated: • If no suspect medical device is involved in a reported – Include the word continued at the end of each field adverse event (i.e., when reporting ONLY a suspect of FDA Form 3500A that has additional information drug or biologic), ONLY sections A, B, C, E, and G are continued onto another page to be filled out: – Identify all attached pages as Page __ of __ – Section G (All manufacturers) may be substituted for section D (Suspect medical device) on the front – Indicate the appropriate section and block number of the form to enable the submission of a one page next to the narrative continuation form – Display the User Facility, Importer, or Manufacturer/ – If section G is reproduced on the front of the form Compounder report number in the upper right it must be an identical reproduction of the original corner as applicable section G – Include the firm’s or facility’s name in the upper • All submissions must be made in English, including right corner as well, if the report is from a user foreign literature reports. facility, importer, or manufacturer • Vaccines: adverse events involving vaccines should • If the case report involves more than two (2) suspect be reported to the Vaccine Adverse Event Reporting products attach another copy of Form FDA 3500A, System (VAERS), http://vaers.hhs.gov/index. For with only section C filled in as appropriate. additional information or assistance with filing a • For a user facility, if more than one medical device is VAERS report, call: 1-800-822-7967. suspected to have caused or contributed to a patient • Devices: Federal law provides that user facility reports death or serious injury, the user facility can submit that are required by law may not be used in private one report for the event. Prepare a complete Form civil litigation actions unless the party who made FDA 3500A for the device that is most likely to have the report had knowledge the report contained false caused or contributed to the event and a separate information. 21 USC 360i(b)(3). Form FDA 3500A with only section D (Suspect Medical Device) and Blocks F9, F10, F13, and F14 filled in for each additional device. Identify each report FRONT PAGE as device 1, device 2, etc. At the top of the front page • A user facility is required to report a device-related Enter the page number and total number of pages death or a device-related serious injury to the submitted (include attachments in the total) where the manufacturer and to report a device-related death to words Page __ of __ are indicated. FDA. • Manufacturers must prepare and submit a complete On the top-right corner of the front page, enter the Form FDA 3500A for each suspect device. Manufacturer report number, User Facility report number, Each Form FDA 3500A will be given a separate or Importer report number in the correspondingly labeled Manufacturer Report Number. box. Enter both report numbers, if applicable, to cross- reference this report with a report from another source • If the suspect medical device is a single use device on the same event. that has been reprocessed for use in humans, then the reprocessor is the manufacturer. The Manufacturer report #: This is the unique identifier manufacturer can be either an Original Equipment used by the manufacturer for this report. For a follow- Manufacturer (OEM), or a Reprocessor of Single- up report, the manufacturer report number must be Use Devices, which also can be a User Facility that identical to the number assigned to the initial report. The reprocesses Single-Use Devices. (See the following manufacturer report number is also entered in block G9 table.) on the back of the form. FORM FDA 3500A SUPPLEMENT (4/16) – FORM INSTRUCTIONS Page 1 of 15 PSC Publishing Services (301) 443-6740 EF GENERAL INSTRUCTIONS (Continued) • For device manufacturers: The report number 10 digits, enter ONLY these numbers, leaving the consists of three components: the manufacturer’s remainder blank (zeros will be automatically filled FDA registration number for the manufacturing site of in by the system). If a facility does not have a CMS the reported device, the 4-digit calendar year, and a number, the first report and any subsequent reports consecutive 5-digit number for each report filed during should be submitted with all zeros in the CMS space the year by the manufacturer (e.g., 1234567-2016- (e.g., 0000000000-2016-0001), and FDA will assign 00001, 1234567-2016-00002). If the manufacturing a number to be used in future reports. If a facility has site does not have a registration number, then FDA more than one CMS number, the facility must select will assign a temporary one to be used until the site is one of those numbers as the primary number and use officially registered. it for subsequent submissions. • For drug and biologics manufacturers: The “mfr If a user facility has multiple sites, the primary site can report #” is the number the manufacturer chooses to report centrally and use one reporting number for all uniquely identify the report, and should conform to sites IF the primary site provides an addendum that any applicable regulations or guidances. identifies the name, address, and CMS number for the other sites. • For human cell, tissue, and cellular and tissue- based product (HCT/P) manufacturers: The report • The importer report number consists of three number should consist of three numbers separated components: the FDA-assigned registration or by dashes. The first number will be the 10-digit FDA identification number for the importer of the device, Establishment Identifier (FEI) number, which was the 4-digit calendar year, and a consecutive 5-digit assigned to you as part of the Human Cells and number for each report filed during the year by the Tissue Establishment Registration (HCTERS). The importer (e.g., 1234567-2016-00001, 1234567-2016- second number should be the year that you are 00002). If an importer does not have an assigned submitting the report. The last number should be a identification number, it should use all zeros in the consecutive 5-digit number for each report filed during appropriate space on the initial report, and continue the year by the manufacturer. Example: 1234567890- to use zeros on subsequent reports until the FDA- 2016-00005 assigned number is received. The importer would still • If submitting a follow-up to a report originally obtained enter the 4-digit calendar year and 5-digit sequence from FDA through a MedWatch to Manufacturer number. Program, check the other box in block G3 and enter • Note: In cases where a reporting site is registered the FDA-assigned report number there. as both a manufacturer and an importer, and the registration and/or FDA-assigned identification UF/Importer report #: This is the unique identifier used numbers are identical for both, then the 5-digit by the user facility or the importer for this report. For a sequence number for reports submitted during the follow-up report, the UF/Importer report number must be year by either one may NOT be duplicated. For identical to the number assigned to the initial report. The example, for devices manufactured by the firm, UF/Importer report number is also entered in block F2 on the report number would consist of the registration the back of the form. number, calendar year, and a consecutive 5-digit • The user facility report number consists of three number (e.g., 1234567-2016-00001, 1234567-2016- components: the facility’s 10-digit Centers for 00002, and so on). For devices imported by the firm, Medicare & Medicaid Services (CMS) number, the the registration number and year would remain the 4-digit calendar year, and a consecutive 4-digit same, but the 5-digit sequence number must be number for each report filed during the year by the different (e.g., 1234567-2016-00003, 1234567-2016- facility (e.g., 1234567890-2016-0001, 1234567890- 00004, and so on). 2016-0002). If the CMS number has fewer than FORM FDA 3500A SUPPLEMENT (4/16) – FORM INSTRUCTIONS Page 2 of 15 SECTION A: PATIENT INFORMATION Complete a separate form for each patient. initial reporter (if different) to locate the case if contacted for follow-up. Do not use the patient’s name, medical If you are a user facility reporting an event where record number or social security number. multiple patients were adversely affected at the same time through the use of one device, you do not need to The patient’s identity is held in strict confidence by FDA file a separate form FDA 3500A for each patient as long and protected to the fullest extent of the law. The FDA as you: will not disclose the reporter’s identity in response to a request from the public, pursuant to the Freedom of • Indicate the number of patients in block B5 (describe Information Act.