Clinical Trial

The FDA’s post-market surveillance program is designed to keep an eye on the efficacy and safety of pharmaceuticals and medical devices that have already received market approval. This is accomplished through an adverse event reporting system, which enables medical experts, patients, and customers to document any adverse reactions, side effects, or other issues connected to a specific product. Adverse occurrences include any unexpected or unsafe side effect, no matter how little or severe, as well as any product-related flaw, malfunction, or failure that could jeopardize a patient.

Methods of conducting post-market surveillance:

  • Review of adverse event reports submitted by healthcare professionals, consumers, and manufacturers.
  • Conducting inspections of manufacturing facilities and other establishments involved in the production and distribution of medical products.
  • Analyzing data from electronic health records, claims databases, and other sources of real-world evidence.
  • Conducting Post Approval studies by Manufacturers to gather additional information about a product’s safety and effectiveness in a real-world setting.
  • Collaborating with other regulatory agencies around the world to share information about safety concerns and potential risks associated with medical products.

General process for reporting post-market surveillance events:

  • Identify the Event: Healthcare professionals, consumers, and manufacturers should identify any adverse events or product defects.
  • Determine if the Event is Reportable: They should determine if the event meets the criteria for reporting to the FDA. The FDA has specific requirements for reporting adverse events and product defects, which can vary depending on the type of product and the severity of the event.
  • Report the Event to the FDA: Report the determined adverse events and product defects to the FDA via submitting an online report through the FDA’s MedWatch program (or) completing and mailing a paper form, (or) calling the FDA’s toll-free number to report the event over the phone.
  • Provide Information About the Event: They should provide as much information as possible about the event when reporting it to the FDA. This information can include as following,

– Age, gender, and medical history of the patient

– A description of the adverse reaction, including the time it started, how severe it was, and what happened.

– The brand and dose of the product(s) that caused the adverse response, along with how frequently & for how long.

– If known, the reporter’s name and contact information

– Any pertinent outcomes from diagnostic or laboratory tests.

– Anything else that might be relevant, like concurrent drugs or underlying illnesses that may have influenced the adverse reaction.

  • Follow-Up with Additional Information: FDA may contact the reportees for additional information about the event. It is important to respond promptly and provide any requested information to help the FDA evaluate the safety of the product.

Timeframes by different professionals to report the adverse events:

  • Healthcare Professionals: Healthcare professionals, including physicians, nurses, and pharmacists, are required to report adverse events within 15 calendar days of becoming aware of the event. For serious adverse events that result in death or serious injury, healthcare professionals are required to report the event to the FDA within 7 calendar days of becoming aware of the event.
  • Consumers: Consumers, including patients and caregivers, are encouraged to report adverse events to the FDA as soon as possible after they occur.
  • Manufacturers: Manufacturers are required to report adverse events to the FDA as part of their post-market surveillance obligations. The timeframe for reporting adverse events varies depending on the type of product and the severity of the adverse event.
  • Example, manufacturers of medical devices are required to report serious adverse events within 30 calendar days of becoming aware of the event,
  • Manufacturers of prescription drugs are required to report serious adverse events within 15 calendar days of becoming aware of the event.

By following the reporting guidelines and timeframes set by the FDA, all stakeholders can help ensure that the necessary safety measures are taken and that the public is protected from potential risks associated with medical products.

Read more about FDA’s Post-Market Surveillance and Adverse Event Reporting Requirements here –

 Postmarketing Surveillance Programs | FDA and Related Resources section of the same link.

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