The guidance comes as the Government Accountability Office (GAO) said last October that 90% of the postmarket surveillance studies FDA ordered over the past seven years were categorized as inactive, though some of these studies were added to other ongoing studies.
Most recently, FDA sent a warning letter to Israel-based Argo Medical Technologies after its failure to conduct such post-market surveillance studies for its device meant to help individuals with spinal cord injuries.
Background
The Federal Food, Drug, and Cosmetic Act (FD&C Act) provides FDA with the authority to require manufacturers to conduct postmarket surveillance of certain class II or class III devices, though FDA notes that postmarket surveillance is not a substitute for obtaining the necessary premarket information to support 510(k) clearance, PMA, HDE, or PDP approval, or grant of de novo order.
In addition, the Food and Drug Administration Safety and Innovation Act (FDASIA) further specified that the agency may issue a postmarket surveillance order at the time of device approval or any time thereafter. Under what’s known as a “522 order” FDA can call on companies to conduct such postmarket surveillance studies.
The 522 order requires that a manufacturer commence postmarket surveillance no later than 15 months after the day the order is issued.
Eleven comments on the draft version of the guidance included industry group AdvaMed criticizing the vagueness of the draft, while Johnson & Johnson sought more information on the types of devices that will not be subject to such surveillance studies.
New Guidance
According to FDA, the guidance is meant to help device manufacturers subject to section 522 postmarket surveillance orders by providing:
● An overview of the section of the law that allows FDA to require such studies;
● Information on how to fulfill 522 order obligations; and
● Recommendations on the format, content and review of postmarket surveillance plan submissions.
In general, the guidance says the law authorizes FDA to order “prospective postmarket surveillance for duration of up to 36 months unless the manufacturer and FDA agree to extend that timeframe or, if there is no agreement, after the completion of a dispute resolution.”
However, the law also authorizes FDA to require a prospective surveillance period of more than 36 months with respect to a device that has significant use in pediatric populations, though FDA said that in those cases, it intends to work with the manufacturer to determine the appropriate time frame for a pediatric study.
FDA also offers examples of situations that may raise postmarket questions, including:
● Instances where FDA wants to better understand the nature, severity or frequency of suspected problems reported in adverse event reports or in the published literature.
● To obtain more information on device performance in real-world clinical practice.
● To address long term or infrequent safety and effectiveness issues for implantable and other devices for which the premarket testing provided more limited information. “For example, premarket evaluation of a device may have been based on surrogate markers. Once the device is actually marketed, postmarket surveillance may be appropriate to assess the effectiveness of the device in detecting or treating the disease or condition, rather than the surrogate. Data collected through postmarket surveillance may include rates of malfunction or failure of a device intended for long-term use or incidents of latent sequelae resulting from device use,” FDA says.
● To better define the association between problems and devices when unexpected or unexplained serious adverse events occur after a device is marketed, if there is a change in the nature of serious adverse events (e.g., severity), or if there is an increase in the frequency of serious adverse events.
Following the issuance of a 522 order, manufacturers also should submit an interim postmarket surveillance report every six months for the first two years of the surveillance and annually, thereafter, from the date of the surveillance plan approval or other negotiated starting date, FDA says.
Surveillance Plans
FDA also makes clear that it will evaluate any proposed surveillance plans to determine whether they will result in the collection of useful data to answer the surveillance or safety questions.
Accordingly, FDA may issue one of the following decision letters:
Not Acceptable Letter, which is when a submission is found to be administratively incomplete (CDRH offers a checklist for determining whether a submission is administratively complete in the guidance).
Approval Letter
Minor Deficiency Letter, which cites specific minor deficiencies that must be addressed in order for a plan to be approved;
Major Deficiency Letter, which would include serious deficiencies that must be addressed;
Disapproval Letter, which means FDA has determined it is not likely the surveillance plan will result in the collection of useful data to address the postmarket questions. This letter also directs the manufacturer to provide an entirely new submission to address the postmarket questions.
“If a manufacturer disagrees with FDA about the content of the plan or if the plan is disapproved, possible recourse options are described” in the law, FDA says, noting that these include requesting a meeting with the Office Director of FDA’s Office of Surveillance and Biometrics; seeking internal review of FDA’s decision under 21 CFR 10.75; requesting an informal hearing; or requesting a review by the Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee.
And if a manufacturer fails to meet the requirements for obtaining postmarket surveillance plan approval and commence postmarket surveillance within 15 months after a 522 order is issued, the agency says that inaction may result in enforcement action.
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