FDA Issues Draft Guidance for Device Industry and Staff for Postmarket Surveillance – Overview and Summary of Recommendations
What is postmarket surveillance?
Under the Federal Food, Drug and Cosmetic Act section 522, postmarket surveillance is a process through which the FDA can obtain additional safety and effectiveness data for medical devices that have been cleared through the 510(k) process or approved through the premarket approval application (PMA), humanitarian device exemption (HDE) or product development plan (PDP) processes.
The draft guidance from the FDA on postmarket surveillance aims at giving:
- An overview of section 522
- Procedural information on fulfilling section 522 requirements
- Recommendations on the format, content, and review of postmarket surveillance study submissions
Applicability
The following devices come under the FDA’s postmarket surveillance requirements:
- A class II or class III device for which failure of the device would be reasonably likely to have a serious adverse health consequence
- A class II or class III device expected to have significant use in pediatric populations
- A class II or class III device intended to be implanted in the human body for more than one year
- A class II or class III device intended to be a life-sustaining or life-supporting device used outside of a user facility
Duration of postmarket surveillance study
Section 522 authorizes the FDA to order prospective postmarket surveillance for a period of up to 36 months unless the manufacturer and FDA agree to extend that timeframe.
Further amendments to the act authorize the FDA to require a prospective surveillance period of more than 36 months for pediatric devices. This is allowed by the act especially if the extended length of time is necessary to assess the device’s impact on growth and development, or the effects of growth, development, activity level, or other factors on the safety or efficacy of the device.
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Pre-522 Postmarket Surveillance Process
The following are the steps that have to be followed before a 522 order is issued for postmarket surveillance:
- Identification of the issue: CDRH staff will identify device issues that are appropriate for studying in a postmarket surveillance study at any point during the life cycle of the device. These may be identified through a variety of sources including analysis of adverse event reports, a recall or corrective action, post-approval study data, review of premarket data, reports from other governmental authorities, or review of scientific literature.
- Team review of issue: The device issue identified is brought to the 522 Team Lead who then establishes a cross-Center team to review the issue in more depth. The team will have in-depth discussions before making a recommendation to the DEPI Division Director and OSB Director as to whether or not a 522 order should be issued to address a public health question.
- Issuance of 522 order: An order for postmarket surveillance will generally be issued by the OSB Director. It will identify the premarket submission involved (i.e., 510(k), PMA, PDP, or HDE), the public health question, the rationale for the 522 order, and study design recommendations to assist in preparing the postmarket surveillance plan.
Postmarket Surveillance Study Plans
The draft guidance details the various requirements and recommends how to fulfill the FDA’s regulations for postmarket surveillance. The following elements of the study plans are detailed in the document:
- Elements to include in the postmarket surveillance study plan – List of elements that have to be part of the study
- FDA and Sponsor Agreement on study plan – The FDA issues the 522 order and sponsors have to create an appropriate study plan for postmarket surveillance in consultation with the FDA
- Change to an approved postmarket surveillance study plan – The FDA’s approval has to be obtained by sponsors before making any changes to postmarket surveillance study plans
- Types of postmarket surveillance – Details the different types of plans that can be used to conduct safety and effectiveness assessment of devices
Postmarket surveillance study reports
There are two types of postmarket surveillance study reports accepted by the FDA:
- Interim reports: These reports are written and submitted to the FDA before the study is completed and this section of the draft guidance details the submission process, sponsor’s reporting status categories and the evaluation process for these reports.
- Final reports: These are written and submitted to the FDA upon completion of the study and the guidance details the submission process, sponsor’s reporting status categories and evaluation process for these reports.
The guidance also gives the required details for interim and final study reports.
How the new draft differs from previous documents
The new draft guidance on postmarket surveillance for medical devices has substantive additions when compared to the 2006 version. These include:
- Guidance regarding the pediatric criterion added by section 307 of FDAAA
- Recommendations for the content of postmarket surveillance study submissions, consistent with previous FDA requests
- Descriptions of study status categories that more precisely indicate study progress and the adequacy of the data
- Updated procedures based on the transfer of the program area to Division of Epidemiology (DEPI), Office of Surveillance and Biometrics (OSB)
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