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Credit: FDA
The US Food and Drug Administration (FDA) is proposing a new program to provide patients with earlier access to high-risk medical devices intended to treat or diagnose serious conditions whose medical needs are unmet by current technology.
The proposed program is called Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions (shortened to EAP).
The goal of EAP is to reduce the time for premarket review of a device and the time associated with product development.
EAP allows for earlier and more interactive engagement with FDA staff, including the involvement of senior management and a plan for collecting the scientific and clinical data to support approval. The FDA says these features should help provide patients with earlier access to safe and effective medical devices.
To be eligible for participation in the program, a medical device must:
• Be intended to treat or diagnose a life-threatening or irreversibly-debilitating disease or condition
• Have an acceptable data development plan that has been approved by the FDA
• Represent 1 of the following:
1. No approved alternative treatment/diagnostic exists
2. A breakthrough technology that provides a clinically meaningful advantage over existing technology
3. Offers a significant, clinically meaningful advantage over existing approved alternatives
4. Availability is in the patient’s best interest.
In addition to the EAP, the FDA published a separate draft guidance that outlines the agency’s current policy on when data can be collected after product approval and what actions are available to the FDA if approval conditions, such as postmarket data collection, are not met.
Included in the guidance is advice on the use of surrogate or independent markers to support approval, similar to the data points used for accelerated approval of prescription drugs.
The FDA is seeking public comment on both documents:
Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions - Draft Guidance for Industry and FDA Staff
Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Draft Guidance for Industry and FDA Staff. 
device responds to stress
Credit: FDA
The US Food and Drug Administration (FDA) is proposing a new program to provide patients with earlier access to high-risk medical devices intended to treat or diagnose serious conditions whose medical needs are unmet by current technology.
The proposed program is called Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions (shortened to EAP).
The goal of EAP is to reduce the time for premarket review of a device and the time associated with product development.
EAP allows for earlier and more interactive engagement with FDA staff, including the involvement of senior management and a plan for collecting the scientific and clinical data to support approval. The FDA says these features should help provide patients with earlier access to safe and effective medical devices.
To be eligible for participation in the program, a medical device must:
• Be intended to treat or diagnose a life-threatening or irreversibly-debilitating disease or condition
• Have an acceptable data development plan that has been approved by the FDA
• Represent 1 of the following:
1. No approved alternative treatment/diagnostic exists
2. A breakthrough technology that provides a clinically meaningful advantage over existing technology
3. Offers a significant, clinically meaningful advantage over existing approved alternatives
4. Availability is in the patient’s best interest.
In addition to the EAP, the FDA published a separate draft guidance that outlines the agency’s current policy on when data can be collected after product approval and what actions are available to the FDA if approval conditions, such as postmarket data collection, are not met.
Included in the guidance is advice on the use of surrogate or independent markers to support approval, similar to the data points used for accelerated approval of prescription drugs.
The FDA is seeking public comment on both documents:
Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions - Draft Guidance for Industry and FDA Staff
Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Draft Guidance for Industry and FDA Staff.
device responds to stress
Credit: FDA
The US Food and Drug Administration (FDA) is proposing a new program to provide patients with earlier access to high-risk medical devices intended to treat or diagnose serious conditions whose medical needs are unmet by current technology.
The proposed program is called Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions (shortened to EAP).
The goal of EAP is to reduce the time for premarket review of a device and the time associated with product development.
EAP allows for earlier and more interactive engagement with FDA staff, including the involvement of senior management and a plan for collecting the scientific and clinical data to support approval. The FDA says these features should help provide patients with earlier access to safe and effective medical devices.
To be eligible for participation in the program, a medical device must:
• Be intended to treat or diagnose a life-threatening or irreversibly-debilitating disease or condition
• Have an acceptable data development plan that has been approved by the FDA
• Represent 1 of the following:
1. No approved alternative treatment/diagnostic exists
2. A breakthrough technology that provides a clinically meaningful advantage over existing technology
3. Offers a significant, clinically meaningful advantage over existing approved alternatives
4. Availability is in the patient’s best interest.
In addition to the EAP, the FDA published a separate draft guidance that outlines the agency’s current policy on when data can be collected after product approval and what actions are available to the FDA if approval conditions, such as postmarket data collection, are not met.
Included in the guidance is advice on the use of surrogate or independent markers to support approval, similar to the data points used for accelerated approval of prescription drugs.
The FDA is seeking public comment on both documents:
Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions - Draft Guidance for Industry and FDA Staff
Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Draft Guidance for Industry and FDA Staff.