Post-Market Medical Device Requirements

Medical devices inevitably possess risk, so manufacturers should continue to evaluate their products after they reach the market. By creating an effective post-market surveillance plan, you can increase user safety and satisfaction.

What is post-market surveillance (PMS)?

Medical device manufacturers hope to create safe and effective products, but not every device immediately functions as intended. Regardless of testing and attentiveness during the development process, your device may still pose a risk to users, so it is imperative to continue evaluating the product after it reaches the market.

This evaluation process – called post-market surveillance (PMS) – allows you to continually examine the performance of your device via continuous user feedback, ensuring that you achieve high standards of product quality and patient satisfaction(1). If your device is ever involved in an adverse event (AE), PMS will help you evaluate this incident, determine corrective action, and prevent similar mistakes.

Should My Company Conduct Post-Market Surveillance?

The FDA can require device manufacturers to study the performance of their high-risk devices, even after receiving 510(k) clearance or PMA approval. These requirements are mostly frequently applied to class II and III devices which meet any of the following criteria:

  • Device failure would likely result in serious adverse effects.
  • The device is intended to be implanted in the human body for longer than 1 year.
  • The device is intended for outside of a healthcare facility to support or sustain life.(2)

If you are required to undergo the surveyal process, the FDA will send you a post-market surveillance order. This document will specify the device(s) subject to the order and the reason for review. It will also provide guidance for developing a post-market surveillance system.

How Do I Demonstrate Compliance?

An outline of this system must be submitted within 30 days of receiving the surveillance order, along with contact information for the designated person who will conduct or supervise the execution of your plan. You will also need to include the following administrative information:

  1. Your organization’s name and address;
  2. Generic and trade names for your device;
  3. The name and address of the submission’s contact person;
  4. The device’s pre-market application number and identifiers;
  5. A description of the device;
  6. Product codes and a list of all relevant model numbers; and
  7. Indications for use and claims for the device.3 

If you fail to comply with post-market surveyal requirements, the FDA will consider your device misbranded.

Creating a Post-Market Surveillance System

A plan for executing post-market surveillance is the most important element of meeting FDA regulations, but PMS system also allow device manufacturers to:

  1. Detect manufacturing problems;
  2. Improve device quality;
  3. Understand long-term device performance in a variety of user populations;
  4. Gain feedback on instructions and required training for use; and
  5. Identify and manage adverse events.

By establishing standards and protocol for evaluating your device’s functionality, you can improve your device, provide better service to users, and mitigate the risk of AEs (potentially reducing liability costs). Here are the steps to create an effective post-market surveillance system.

Evaluate Your Device’s Risk

Perform a risk assessment on your device, focusing on both identification and analysis(4). Risk identification determines all the relevant risks posed by your device, including in the event of incorrect usage. It is important to list every potential negative outcome – including worst-case scenarios – rather than just the most pressing concerns. 

During the risk analysis process, you will examine each identified risk using four factors:

  1. Likelihood: How likely is the risk to occur? What factors might affect this likelihood?
  2. Impact: What are the potential consequences of this outcome? How severe would they be?
  3. Velocity: How quickly would these consequences occur? Would you be able to warn other users before they are similarly affected?
  4. Materialization: Would this consequence negatively impact your manufacturing enterprise? Would this harm your reputation or financial situation?(5)

You can use this information to assign each risk a status of high, medium, or low priority. These designations can help you determine the order in which you address concerns, while also helping you determine whether your device presents an acceptable level of risk.

The FDA evaluates acceptable risk through a risk-benefit analysis, weighing evidence of the device’s clinical benefit against any risk it may pose.6 For example, the acceptable risk level for a low-benefit product will be low, while a higher risk level may be tolerated for devices with substantial benefits. Once your product reaches the market, this framework may prove useful for continually improving your device.

Monitor and Control Identified Risks

Your surveillance system should incorporate two categories of actionable protocol:

  1. Proactive Steps: including consumer surveys and PMCF studies; and
  2. Reactive Steps: including vigilance and reporting.

PCMF studies, or post-market clinical follow up studies, examine how your device performs when used as intended, allowing you to verify its clinical performance and to collect data on patient safety. If this study returns unsatisfying results, you can address the identified problems and potentially prevent adverse events. Consumer surveys afford similar benefits.

If proactive steps fail to prevent an adverse event, your PMS system should contain steps for evaluating and reporting this occurrence. Vigilance standards require manufacturers to report serious AEs to relevant regulatory bodies through programs like the FDA’s Adverse Event Reporting System (FAERS) (7)(8).

When producing an incident report, you should carefully examine the event, taking action to improve the device and prevent any additional harm. Your proactive feedback systems may be helpful when making these improvements. Reactive elements of your PMS system should also include steps to minimize the spread of incidents through warning messages and product recall procedures(9).

Analyze and Review Data

It is important to ensure that all applicable personnel are properly trained to document relevant information. This includes customer service representatives, sales representatives, distributors, and anyone else who may receive feedback from users. Collected data should feed into documents like a Risk Management File and Clinical Evaluation Report (CER)(10). This may help you identify additional risks and will provide an additional aid in determining whether the device’s risk level is within an acceptable range.

Effective PMS systems will include formal data reviews on either a monthly or quarterly basis, depending on the quantity and type of feedback received. You should evaluate each complaint or adverse event to determine whether further action is necessary. If it is, you can then determine and delegate effective steps.

Post-market surveillance is not a one-time project, but an ongoing process of review and revision throughout the life of a device. Manufactures dedicated to monitoring their products will gain the benefits of fewer defects, increased user safety, and higher customer satisfaction. The manufacturers also demonstrate a commitment to patient safety and healthcare excellence.

References

  1. Food and Drug Administration. (2016). Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff. https://www.fda.gov/media/81015/download
  2. Ibid.
  3. Ibid.
  4. Food and Drug Administration. (2006). Guidance for Industry: Q9 Quality Risk Management. https://www.fda.gov/media/71543/download
  5. Walsh, K. (2020, August 29). Risk Assessment vs Risk Analysis. Retrieved from https://reciprocitylabs.com/risk-assessment-vs-risk-analysis-whats-the-difference/
  6. Food and Drug Administration. (2016). Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: Guidance for Industry and Food and Drug Administration Staff. https://www.fda.gov/files/medical%20devices/published/Factors-to-Consider-Regarding-Benefit-Risk-in-Medical-Device-Product-Availability–Compliance–and-Enforcement-Decisions—Guidance-for-Industry-and-Food-and-Drug-Administration-Staff.pdf
  7. Food and Drug Administration. (2016). What is a Serious Adverse Event? https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event
  8. Food and Drug Administration. (2019). FDA Adverse Event Reporting System (FAERS) Public Dashboard. https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard
  9. Food and Drug Administration. (2020). Industry Guidance for Recalls. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/industry-guidance-recalls
  10. What is a Clinical Evaluation Report (CER)? (2019, December 19). Retrieved from https://www.emergobyul.com/resources/cer-quick-answers

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