POST-MARKET SURVEILLANCE AND MEDICAL DEVICE REPORTING
Post-market surveillance (PMS) programs are indispensable in a medical device development plan. It is a regulatory requirement for many countries such as the United States and European Union.
Under PMS, a medical device manufacturer has the obligation to continuously monitor the use of their products after it is approved for sale. In other words, the regulatory agency in these markets will task the manufacturer to keep a watchful eye on their product safety, and in the event of any significant adverse device events happening, the manufacturer can examine the root causes and learn something from these incidents.
The regulatory landscape of PMS
Traditionally, PMS depended on reactive data collection where the manufacturers collated reports of adverse device effects from the users. However, in recent years there have been significant efforts to transition into a more proactive process. In particular, the increasing complexity of medical devices and data capture capability has called for the utilization of real-time performance data to predict and prevent adverse events before they occur.
In the United States, the Food and Drug Administration (FDA) requires manufacturers to perform postmarketing studies on certain devices that have received 510(k) clearance or PMA approval (21 CFR Part 822). Additionally, under the Medical Device Reporting (MDR) regulation (21 CFR Part 803), manufacturers, importers, and device user facilities are mandated to report certain device-related adverse events and product problems through the electronic MDR system.
PMS requirements in the United States
We have summarized the key requirements of PMS in the US according to the regulation on Postmarket Surveillance:
- FDA has the authority to order PMS of any class II or class III medical devices that fulfill the following criteria
- Failure of the device would be reasonably likely to have serious adverse health consequences
- The device is intended to be implanted in the human body for more than 1 year; or
- The device is intended to be used to support or sustain life and to be used outside a user facility
- FDA may order PMS for a period of up to 36 months (longer periods are possible, but require the manufacturer’s agreement).
- In general, medical devices with a higher risk are more likely to require PMS. Class I devices typically do not need PMS as they have lower risks.
- Once the order for PMS has been given, the manufacturer must submit a PMS plan within 30 days of receiving such an order. The PMS plan must include the following key features:
- Objective(s) addressing the surveillance question(s) identified in the FDA’s order
- The subject (patients, device, animals)
- The variables and endpoints (primary and secondary) that will be used to answer the surveillance question
- Patient population, including a description of the inclusion/exclusion criteria
- A sample size that is justified via statistical calculation
- The surveillance methodology
- Description of the follow-up schedules, length, and assessments that will be performed
- Data collection and statistical analysis plan
- Reporting schedules for interim and final reports
- Interim and final data analysis
Final thoughts
Regulators in many countries are becoming more stringent toward the medical device industry. While standards across these important markets are quickly harmonizing, navigating the complex landscape of PMS could still be a challenge for many medical device manufacturers. It is important to establish a PMS system that is compliant with the regulatory requirements of all major markets to facilitate sales in the regions.
On top of that, conducting PMS also allows the manufacturer to collect performance and safety data throughout the device’s lifetime. This information is critical to building a complete risk/benefit profile for the devices.
At Synergy Bioscience, we have extensive expertise in postmarketing surveillance for medical devices and we are ready to help you to optimize your PMS elements for regulatory submission. Having a trusted partner with experience in regulatory preparedness and submission is critical to your success.