FDA Post-Market Medical
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The Food and Drug Administration (FDA) is responsible for the safety and effectiveness of medical devices on the market. As such, the agency has established post-market surveillance (PMS) requirements for medical device manufacturers and distributors. These requirements are designed to monitor the performance of medical devices once they’ve been approved and made available to the public. To learn more, check out our article on MEDDEV post-market surveillance.
The FDA uses post-market surveillance for medical device guidance. This includes adverse event reporting, medical device reporting, corrective actions and product performance monitoring. This article will cover the essential requirements and procedures for post-market surveillance compliance in the U.S. and European markets.
PMS Requirements for the U.S.
Although quality system regulations for medical device firms are governed by 21 CFR Part 820 and sub-clause 4.4 of ISO9001, neither of which specifically mentions PMS, manufacturers in the U.S. are still required to conduct such studies. The 522 Post-Market Surveillance Studies Program is managed by the Office of Surveillance and Biometrics of the FDA’s Division of Epidemiology, and they help ensure manufacturers conduct these studies efficiently and effectively.
The FDA holds the legal power to enforce manufacturers to perform post-market surveillance onclass II and class III medical devices that meet certain criteria:
- If a malfunction of said device will likely result in severe negative health effects
- If the device is designed to stay in the patient’s body for longer than a year
- If the product is likely to be used significantly in the pediatric population
- If the tool is designed to be used as a life-supporting or life-sustaining tool outside of a medical context
The FDA has the authority to require manufacturers to perform post-market surveillance in cases of adverse events, to assess the effectiveness and safety of devices with insufficient pre-market testing, and to acquire more data on device performance in clinical settings.
The manufacturer must submit a PMS strategy in response to an FDA request for post-market monitoring—this includes elements that address the original justification for the PMS order. A post-market surveillance report usually includes the following components:
- Details about the device, its regulatory background, description, and intended purposes
- The PMS plan’s objectives
- Goals and hypotheses of the post-market surveillance plan
- The structure of the PMS plan
- The patient group and details about its inclusion and exclusion standards
- A statistically supported calculation of the sample size
- Key and supplementary objectives, including explanations, standards for success, a compilation of potential negative outcomes or issues, and a commitment to record any unanticipated negative outcomes
- Details of follow-up schedules, durations, and evaluation methods
- Required forms for gathering information and a description of the methods and techniques used for data assembly and statistical evaluation
- Timelines for intermediate and final report submission
- Analyses of interim and final data
- Key milestones and timeline components
Post-Market Surveillance Requirements for the EU
Manufacturers are required by Regulation (EU) 2017/745 to include a PMS strategy in their technical documents. Depending on the device’s classification, the plan should be executed to generate PMS reports or PSU reports.
Class I medical devices are required to submit Post Market Surveillance Reports (PMSRs) under the MDR, while class A and B medical devices are required to submit PMSRs under IVDR. PMSRs must include the findings, recommendations, and actions from post-market surveillance programs. Periodic Safety Update Reports (PSURs) are mandatory for class IIa, IIb, and III medical devices as per the MDR, and mandatory for class C and D in-vitro devices as per IVDR. These include determining benefits and risks, significant discoveries, sales figures, and characteristics of the users.
The PMS plan must include the following topics as listed in the Annex III of the MDR:
- A process for gathering information systematically and proactively (such as user feedback and reports)
- Systematic and statistical techniques for evaluating collected data
- Standards for evaluating risk-benefit ratio and managing risk
- The essential tools and methods for looking into complaints
- Procedures for handling events that are subject to a trend report
- Protocols for effectively communicating with users, notified bodies, economic actors, and regulatory authorities
- A guide for meeting the manufacturer’s obligations for the PMS system, PMS plan, and PSUR
- Methods and processes for carrying out corrective actions when required
- Tools for locating and identifying devices that may require corrective action
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What Is PMCF in the MDR?
If you saw the term ‘PMCF’ when researching PMS, you likely wondered what PMCF in the MDR is.
‘PMCF’ stands for Post-Market Clinical Follow-up. It is a proactive, systematic way of collecting clinical data on device use and outcomes. PMS aims to verify the device’s performance and detect potential safety issues as soon as possible. The EU MDR requires a PMCF as one part of a broader, comprehensive post-market surveillance program.