For Medical Devices

Postmarket Surveillance: Are You Prepared for FDA's New Priority?
by Elaine H. Tseng, King & Spalding LLP's FDA/Healthcare Group

FDA is focused on improving postmarket surveillance (PS) to optimize the identification, analysis, and use of postmarket information about medical devices. As such, manufacturers should ensure a thorough understanding of PS requirements and authorities, and can also benefit from robust PS practices.

Consumers became the major source of adverse event reports to the FDA in 2006, replacing physicians---FDAnews Drug Daily Bulletin

What Is Postmarket Surveillance and Why Is It Important?
PS refers to tools and methods used to identify potential safety or effectiveness issues with medical devices post-approval. For certain devices, FDA may order active, systematic PS to address a particular device-specific postmarket question.1 But PS requirements are not limited to this authority. Indeed, for all devices, FDA requires that manufacturers establish compliance systems with respect to more passive mechanisms for PS, including complaint-handling2 and adverse event or Medical Device Reporting (MDR)3; additionally, for nearly all devices, FDA requires compliance with requirements for corrective and preventive actions (CAPA) to detect and address actual or potential device nonconformities.4

FDA has not enforced active PS requirements extensively historically, but the agency has signaled that this practice is likely to change. Complaint, MDR, and CAPA requirements are and have been primary areas for FDA scrutiny. Deficiencies in these areas are frequently the subject of FDA Warning Letters and/or other, more serious enforcement actions that can delay product approvals, curtail sales, prohibit or limit device imports or exports, and/or result in significant civil money penalties. Apart from regulatory enforcement, poor PS practices can lead to reputational harm, increased incidence and costs of product rework, recalls, or other remedial actions, and lost opportunities to improve product quality and maximize value to a firm's potential investors, partners, or purchasers. Conversely, top-line practices can provide competitive advantages and protect against business disruption.

FDA's New Postmarket Surveillance Authority
The FDA Amendments Act of 2007 expanded FDA's pre-existing authority to order active PS under section 522 of the FDCA. Section 522 PS "means the active, systemic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed medical device."5 Active PS can now be ordered for:

  • Any Class II or Class III device

    • The failure of which would be reasonably likely to have serious adverse health consequences; or
    • That is expected to have significant use in pediatric populations; or
    • That is intended to be:

      • Implanted in the human body for more than one year; or
      • A life-sustaining or life-supporting device used outside a device user facility.6

PS is appropriate to address any "important unanswered postmarket question about a marketed medical device."7 Such questions can arise "at any point during the life cycle of the device" (i.e., either pre- or post-clearance/approval).8 Questions prompting PS can arise, for example, when unexpected issues occur after a device is marketed, significant changes are made in device technology, a device is approved based on surrogate endpoints, or its conditions or environments of use are altered. Techniques for PS are varied and can range from randomized, controlled clinical trials, other types of clinical studies, or analyses of registries or secondary data sets to patient/user surveys, non-clinical testing, or detailed reviews of complaints or scientific literature.

Devices subject to PS orders have varied in type (e.g., stent graft systems, orthokeratology shaping contact lenses, home-use automated external defibrillators). It may be appropriate for some manufacturers to consider whether and how PS might be requested or used to address potential performance issues concerning a device. For example, in the premarket context, FDA has advised that, "[w]hile PS will not be used in lieu of adequate premarket testing," FDA "will consider the potential to collect postmarket surveillance data to allow more rapid progress to market" in appropriate circumstances.9

Although ordered by FDA, PS plans are developed by industry, subject to FDA approval. If a PS order is or may be applicable for your device, it will be important to familiarize yourself with the regulatory standards for development and implementation of PS plans, plan content and criteria for acceptance, applicable time limits for which surveillance may be ordered, and opportunities to seek waivers or request review of PS decisions. There are also regulatory requirements regarding the continuation, termination, or transfer of PS obligations (e.g., in the event of sale of product line or cessation of business), as well as regarding appropriate arrangements with third-party investigators or contractors to be involved in PS, that will be pertinent to understand.

Heightened FDA Scrutiny of Postmarket Surveillance: Practical Pointers
As earlier noted, FDA has recently signaled a likely step-up in Section 522 PS activity in the future. Additionally, FDA is actively enforcing compliance with the other PS mechanisms identified above in a manner that reveals some practical lessons:

  • Ensure adequate written procedures and documentation. The biggest opportunities for companies to bolster their PS systems lie in ensuring the establishment and adequacy of written procedures, and in thoroughly documenting their practices. Even if a company actually behaves "by the book," FDA will deem the firm noncompliant if procedures and documentation are inadequate or nonexistent.

  • Ensure adherence to existing procedures. Once procedures have been developed, it is equally important that they be consistently and correctly followed. Here, companies can benefit by not merely ensuring the consistency of their PS procedures with applicable regulations and/or regulatory recommendations and best practices, but also ensuring that the procedures are appropriately clear, specific, and practical to implement. Providing training that is effective, sufficiently inclusive, and that conveys not only how but why to comply, is also important. Performance and compliance may be enhanced if procedures are standardized in the case of companies with multiple business divisions.

  • Optimize the value of PS activities beyond compliance to maximize product performance and marketing prospects. FDA seeks to improve the degree to which its premarket reviews are informed by information available to the agency about postmarket device performance. Like FDA, industry can benefit by increasing its use of postmarket information to guide device development. Where warranted, manufacturers should consider extending their net beyond required or traditional sources of postmarket information to consider a wider range of data to improve new and next-generation medical devices (e.g., to enhance device design or human factor characteristics such as user interfaces, labeling, or user training techniques). Activities in this vein might include affirmatively soliciting customer, user, or supplier feedback, or considering information from sales calls, literature, postmarket studies or analyses, employee or competitor complaints, or legal claims as sources of potentially useful information regarding device enhancement or improvement.

To the extent that FDA may increasingly ask questions during premarket review that are prompted by signals or trends in postmarket information about a similar or related product, companies that position themselves well to anticipate and address such questions may improve their prospects for efficiently and effectively navigating the review process.

PS programs that are comprehensive as well as compliant are important not only to ensure regulatory credibility, but also to maximize device performance and business opportunities.

1 See section 522 of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 360l).
2 See 21 CFR 820.198.
3 See 21 CFR 803.
4 See 21 CFR 820.100.
5 21 CFR 822.3(h).
6 FDCA section 522(a)(1)(A) (21 U.S.C. 360l(a)(1)(A)).
7 Guidance for Industry and FDA Staff; Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act (PS Guidance).
8 Id.
9 Id.

Elaine H. Tseng is a member of King & Spalding LLP's FDA/Healthcare group in San Francisco, California and was previously Regulatory Counsel at the Food and Drug Administration. Ms. Tseng's FDA practice includes advising medical device companies on a variety of FDA matters, including FDA clearance, approval, and postmarket compliance. She is a frequent speaker on topics of FDA regulation, including postmarket surveillance, on which she will present for Thompson Interactive audioconferences on December 4, 2008. Ms. Tseng is a graduate of Cornell University and Harvard Law School. She is also a recipient of the Secretary for Health and Human Services' Distinguished Service Award and other FDA honors.

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