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Compliance In Focus
Posted by Leonard Basobas on Fri, Oct 16, 2015

The Post Market Surveillance Study


 A police siren blares, but only for a brief moment indicating that the police officer just wanted to make his presence known.

In turn, your surprise quickly morphs into frustration as you see the flash of red and blue lights in your rear view mirror.  You pull to the side of the road.

“Do you know why I pulled you over?” the officer posits staring at a roll of papers in his hand.

“Honestly, I am at a loss sir?” you sarcastically reply.  “I just got on the highway to test out my new car, which is just off the assembly line, I might add, and I wasn’t even up to the speed limit yet.”

“Well, you are absolutely correct, you weren’t speeding.”  He quickly retorts.  “But, this Section 522 (holding up his roll of papers) of the law gives me the right to pull you and especially your new car over just to make sure everything is going okay.”

“Ah, so how’s it going?”

 

A 522

Similarly, FDA has the authority to monitor newly cleared/approved devices through a post market surveillance study.  

Section 522 of the Federal Food, Drug and Cosmetic Act (the act), gives FDA the authority to require a manufacturer to conduct post market surveillance of a class II or class III device so that the agency can obtain additional safety and/or effectiveness data for a device after it has been cleared through the premarket notification (510(k)) process or approved through the premarket approval application (PMA), humanitarian device exemption (HDE), or product development plan (PDP) process, when it is necessary to protect the public health. 

But unlike the police officer in the scenario above, in order for FDA to enact a post market surveillance study, the device must meet one or more of the following criteria:

  • a class II or class III device for which failure of the device would be reasonably likely to have a serious adverse health consequence (Section 522(a)(1)(A)(I) of the act); 

  • a class II or class III device expected to have significant use in pediatric populations (Section 522(a)(1)(A)(ii) of the act); 

  • a class II or class III device intended to be implanted in the human body for more than one year (Section 522(a)(1)(A)(iii)(I) of the act); and 

  • a class II or class III device intended to be a life-sustaining or life-supporting device used outside of a user facility (Section 522(a)(1)(A)(iii)(II) of the act). 

522 the Hard Way

In addition to the four main criteria the FDA uses when deciding to enact a post market surveillance study, the Center for Devices and Radiological Health (CDRH) staff may identify device issues that are appropriate for studying in a post market surveillance study at any point during the life cycle of the device. Examples of situations that may raise post market questions, during both the premarket and post market periods, include: 

  • Confirming the nature, severity, or frequency of suspected problems reported in adverse event reports or in the published literature. 
  • Obtaining more experience with a change from hospital use to use in the home or other environment or with new patient populations. 

  • Addressing long term or infrequent safety and effectiveness issues of implantable and other devices for which the premarket testing provided only limited information. For example, premarket evaluation of the device may have been based on surrogate markers. Once the device is actually marketed, post market 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 during post market 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. 

  • Defining 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. 

522 Will Get You Up to 36 and Up

For device manufacturers required to conduct a post market surveillance study of their product, the duration may vary.

In general, section 522(b)(1) of the act authorizes FDA to order prospective post market surveillance for a duration of up to 36 months unless the manufacturer and FDA agree to extend that timeframe.  For a device that is expected to have significant use in pediatric populations, the  prospective surveillance period may be  more than 36 months.  Such an extended duration may be  necessary in order to assess the impact of the device on growth and development, or the effects of growth, development, activity level, or other factors on the safety or efficacy of the device. FDA will work with the sponsor to determine the appropriate timeframe for a pediatric study.

Types of Post Surveillance

Type

Definitions

Randomized Clinical Trial

Prospective study comparing the effects of an intervention(s) against a control group. Subjects are assigned randomly to one of the study groups.

Prospective Cohort Study

A study in which the subjects in a defined population are followed prospectively in time to assess the occurrence of outcomes of interest as they occur. Such studies can include one or more groups defined in terms of their exposure to a device.

Retrospective Cohort Study

A study in which the subjects in a defined population are followed forward in time; however, unlike a prospective cohort, the data records documenting the device exposure and outcomes have been collected in the past relative to the time when the study is initiated. Such studies can also include one or more groups defined in terms of their exposure to a device.

Cross-Sectional Study

Study in which the presence or absence of an exposure and health outcome are assessed at the same point in time.

Enhanced Surveillance

Continued monitoring of the distribution and trends in the incidence of adverse events through ongoing, passive but systematic collection, analysis, and interpretation of data. The surveillance may be designed to collect information on events that are both MDR-reportable and MDR non- reportable adverse events or device complaints.

Active Surveillance

Continued monitoring of the distribution and trends in the incidence of adverse events through ongoing, active systematic collection, analysis, and interpretation of data. The surveillance may be designed to collect information on events that are both MDR-reportable and MDR non-reportable adverse events or device complaints.

Meta Analysis

Systematic review that combines the results of several studies that address a set of related research hypotheses. This is normally done by identification of a common measure of effect size, which is modeled using a form of meta-regression of the published or unpublished study data.

Prospective & Retrospective Study

A hybrid cohort study in which data are collected both retrospectively and prospectively.

Case Control Study

Study in which subjects are identified on the basis of the presence or absence of an outcome (cases) and compared to an appropriate comparison group. The proportions with the exposure of interest are compared.

Bench/Lab Study

A study that involves bench testing (e.g., wear testing, fatigue testing).

Animal Study A study that involves animal testing (e.g., device or material implanted in animal).
Other Study Design

A study design that does not fit one of the other categories.

 

Research Coordinator Support blog CTA

Topics: FDA, Post Market Surveillance Study, Section 522

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