The FDA’s reporting obligations are limited to specific events “that you receive or otherwise become aware of .　.　. from any source.” 21 C.F.R. §803.50. This is an FDA-defined term, meaning: .　.　.We consider the following information to be reasonably known to you: (i) Any information that you can obtain by contacting a user facility, importer, or other initial reporter; (ii) Any information in your possession; or (iii) Any information that you can obtain by analysis, testing, or other evaluation of the device.Id. §803.50(b)(1).

FDA issued this order to implement certain provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which amended the Medical Device Reporting (MDR) requirements under the Federal Food, Drug, and Cosmetic Act to allow reporting of malfunctions for certain Class I and Class II devices in summary form on a quarterly basis, in accordance with criteria to be established by FDA. FDA’s regulations at 21 CFR Section 803.50(a)(2) require device manufacturers to submit an MDR within 30 days of becoming aware of a device malfunction that would likely cause or contribute to a death or serious injury should the malfunction recur. The Voluntary Malfunction Summary Reporting Program, however, will provide an alternative method of compliance for malfunctions that involve Class I and Class II devices that are not permanently implantable, life supporting, or life sustaining.

FDA requires manufacturers to submit information “reasonably known” to them in their medical device reports. The attributes of information “reasonably known” to manufacturers are provided in 21 CFR Part 803.50(b). This includes:information the manufacturer can obtain by reaching out to a user facility, importer, or other initial reporter of a complaint,information already in the possession of the manufacturer,information the manufacturer may obtain from analyzing or testing returned product, andinformation from other similar reports.As a general rule, manufacturers must make three good-faith attempts, with one attempt in writing, to obtain information all the information required by 21 CFR 803.52 when submitting a Medical Device Report.

The final guidance takes a position directly in contrast to that above, stating:The MDR regulation at 21 CFR 803.3 defines a “manufacturer” to include a firm that initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications. A contract manufacturer who does not distribute or market the devices it manufactures for a specifications developer would not have an MDR reporting obligation under 21 CFR 803.50 and would not require an exemption. However, if the contract manufacturer (Firm A) distributes or markets the devices that it manufactures for the specifications developer (Firm B), then both would have an MDR reporting obligation.

As background, under FDA’s Medical Device Reporting (“MDR”) regulation (21 C.F.R. Part 803), a malfunction must be reported to FDA if is “likely” to cause serious injury or death upon recurrence. 21 C.F.R. § 803.50. In the preamble to this regulation, FDA explains its interpretation of “likely” as meaning a “not remote” probability of serious injury or death. 60 Fed. Reg. 63,577, 63,585 (Dec. 11, 1995).

Essentially, FDA criticizes the target company for following the agency’s own written guidance on this issue.As background, under the MDR regulation, a malfunction is reportable if a recurrence would likely cause serious injury or death. 21 C.F.R. § 803.50(a). The question is, if a malfunction actually causes a serious injury or death, must the manufacturer presume that subsequent occurrences of the malfunction are “likely” to do so as well?

As background, a malfunction complaint is reportable to FDA if a recurrence would be likely to cause or contribute to a death or serious injury. See 21 C.F.R. § 803.50(a)(2). In this case, there were complaints of ventilator malfunction that were not reported that FDA apparently believes should have been reported.