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Postmarket Surveillance Studies

• Introduction
  
• Devices Subject to Postmarket Surveillance Studies
  
• Postmarketing Surveillance Guidance Documents

Introduction

Manufacturers must conduct postmarket surveillance studies to gather safety and efficacy data for certain devices introduced into interstate commerce after January 1, 1991. This requirement applies to devices that:

• are permanent implants, the failure of which may cause serious adverse health consequences or death;
  
• are intended for use in supporting or sustaining human life; or
  
• present a potential serious risk to human health.
  
• Under a discretionary provision FDA may require postmarket surveillance for other devices if deemed necessary to protect the public health.
  

The primary objective of postmarket surveillance is to study the performance of the device after marketing as it is to be used in the general population for which it is intended. Generally, the primary variables to be studied are morbidity or mortality. The major interest lies in device failure and its attendant impact on the patient.

Postmarket surveillance is considered a warning system for the early detection of potential problems within a reasonable time of their first marketing. The intent of the regulation is to:

• Identify problems
• Provide safety warnings
• Provide information not available from the medical device reporting regulation
• Provide actual use of safety and effectiveness information.
  

Manufacturers will receive notification that their device is subject to postmarket surveillance upon acceptance of a 510(k) or PMA and again when a decision of substantial equivalence or approval has been made. Within 30 days of introducing their device into interstate commerce, manufacturers must submit a postmarket surveillance protocol to FDA for approval.

Failure to comply with the postmarket surveillance regulation is a prohibited act and will render a device misbranded under the FD&C Act.

Important Note: Effective, February 19, 1998, manufacturers will no longer be automatically required to conduct postmarket surveillance studies for particular devices. Rather, FDA may order such studies to be conducted for certain Class II and Class III devices. The FDA can now order postmarket surveillance for any Class II and Class III device:

• the failure of which would be reasonably likely to have serious adverse health consequences; or
  
• which is intended to be implanted in the human body for more than one year; or
  
• which is intended to be a life sustaining or life supporting device used outside a device user facility.
  

Manufacturers must, within 30 days of receiving an order to conduct a postmarket surveillance study from FDA, submit, for approval, a plan for the required surveillance. The FDA may order a study for up to 36 months. Any longer period has to be mutually agreed upon by the manufacturer and FDA. If no agreement on a longer time period can be reached, then a dispute resolution process is to be followed.

After receiving the manufacturer’s proposed plan, FDA has 60 days to determine if the person designated to conduct the surveillance is qualified and experienced, and if the plan will collect useful data that can reveal unforeseen adverse events or other information necessary to protect the public health.

All postmarket surveillance studies ordered under Section 522 of the FFD&C Act should continue at this time. The FDA plans to individually contact the manufacturers currently conducting postmarket surveillance studies to confirm whether the ongoing studies should be completed.

Devices Subject to Postmarket Surveillance Studies

The effective date requiring these studies for the permanent implant devices listed below was November 8, 1991.

• Annuloplasty Ring
• Automatic Implantable Cardioverter Defibrillator
• Cardiovascular Permanent Pacemaker Electrode (Lead)
• Coronary Vascular Stent
• Implantable Pacemaker Pulse Generator
• Implanted Diaphragmatic/Phrenic Nerve Stimulator
• Replacement Heart Valve
• Total Artificial Heart
• Tracheal Prosthesis
• Vascular Graft Prosthesis (any diameter)
• Ventricular Assist Device - Implant
  

Added to the list effective August 29, 1993 were:

• Glenoid Fossa Prosthesis
• Implantable Infusion Pumps
• Implanted Cerebellar Stimulators
• Interarticular Disc Prosthesis (Interpositional Implant)
• Mandibular Condyle Prosthesis
• Total Temporomandibular Joint Prosthesis
  

Postmarketing Surveillance Guidance Documents

General guidance on the development of post market surveillance protocols can be found on the CDRH Facts-On-Demand (F-O-D), document number 497. There are also two product specific guidance documents, implantable cardiac pacemaker electrodes (number 206), and orthopedic implances with metallic plasma sprayed porous coatings (number 946).

Updated 6/8/1998

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