Deleted Tweets From Scott Gottlieb, R-D.C.

In 510(k), manufacturers often rely on comparative testing vs predicate devices to show a new device is as safe and effective as the predicate. But older predicates might not closely reflect the modern tech embedded in new devices or more current understanding of benefits & risks

TWEETORIAL: Today we announced changes to modernize FDA’s 510(k) clearance pathway, used for clearance of low- to moderate-risk devices that are substantially equivalent to a device already on the market, known as a predicate device https://t.co/OefxQVj0UB

A hemodialysis system, which has modernized through miniaturization; and a patient monitoring system that can monitor more patients and/or more parameters and which are increasingly becoming networked in healthcare facilities increasing the risk for cybersecurity threats.

An X-ray system that includes a controller to control time of x-ray exposure. These new devices now meet performance standards and consensus standards that were either not available or have been revised to meet more modern criteria since the predicate device was cleared

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

An infusion pump whose predicate device uses older “beam break” technology to estimate the size of the drop. The new device uses a video camera and vision processing to monitor the drop formation and detect drops falling, making the device more precise and more accurate.

Following are some examples of devices that have been modernized over the past several years, but for which some manufacturers have relied on older predicates:

These examples help illustrate why we believe that newer devices should be compared to the benefits and risks of more modern technologies and why we’re looking at ways to promote the use of more recent predicates

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.

We believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device while promoting greater competition to adopt modern features that improve safety and performance.

A stereotactic system used by neurosurgeons to more precisely determine where to perform their surgical procedure was intended to be MRI compatible but the older predicate it compared itself to was not, requiring additional performance testing.

It would also help make sure that newer devices reflect more modern technologies and standards that can improve patient care and outcomes. It would help the overall product environment continue to evolve in the direction toward safer, more effective devices.

We aim to efficiently advance beneficial technology to patients, while solidifying FDA’s gold standard for safety. Our goal in focusing on older predicates is to drive sponsors to continually offer patients devices with the latest demonstrated improvements and advances in safety.

RT @jonathanrockoff: .@US_FDA is revamping procedures for clearing medical devices, @TomBurtonWSJ reports. https://t.co/tqBcJnBBcM Will… https://t.co/LI6H5dKuyQ

RT @FDA_Drug_Info: TOMORROW: Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions meeting in Washington, DC.… https://t.co/1ARNfRsm4J

RT @foodsafetygov: Still holding on to those Thanksgiving leftovers? Today is the last day to use them! Can’t let go? Freeze them! Fro… https://t.co/HhspfV4tUn

RT @FDATobacco: REMINDER: FDA will hold a public hearing on youth e-cigarette use and strategies to help them quit on Dec. 5 at the… https://t.co/56FGqxOSjW

RT @SGottliebFDA: THREAD: Federal health officials at #FDA and @CDCgov updated our investigation and advice related to the current E.… https://t.co/JxEzOEWjbh

RT @FDAOncology: We're getting set up for today's #FDAOncology 2nd annual educational workshop for new cancer patient advocates, Par… https://t.co/wmWhCb6CYn

RT @BlumenthalG: First histology-agnostic, pan-tumor New Molecular Entity approval. Another example of a targeted therapy developed using… QT @SGottliebFDA: 1/5 Today the #FDA granted accelerated approval to an oncology drug for adult and pediatric patients that targets a… https://t.co/U9smfjrjPf)

In 510(k), manufacturers often rely on comparative testing vs predicate devices to show a new device is as safe and effective as the predicate. But older predicates might not closely reflect the modern tech embedded in new devices or more current understanding of benefits & risks

TWEETORIAL: Today we announced changes to modernize FDA’s 510(k) clearance pathway, used for clearance of low- to moderate-risk devices that are substantially equivalent to a device already on the market, known as a predicate device https://t.co/OefxQVj0UB

A hemodialysis system, which has modernized through miniaturization; and a patient monitoring system that can monitor more patients and/or more parameters and which are increasingly becoming networked in healthcare facilities increasing the risk for cybersecurity threats.

An X-ray system that includes a controller to control time of x-ray exposure. These new devices now meet performance standards and consensus standards that were either not available or have been revised to meet more modern criteria since the predicate device was cleared

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

An infusion pump whose predicate device uses older “beam break” technology to estimate the size of the drop. The new device uses a video camera and vision processing to monitor the drop formation and detect drops falling, making the device more precise and more accurate.

Following are some examples of devices that have been modernized over the past several years, but for which some manufacturers have relied on older predicates:

These examples help illustrate why we believe that newer devices should be compared to the benefits and risks of more modern technologies and why we’re looking at ways to promote the use of more recent predicates

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.

We believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device while promoting greater competition to adopt modern features that improve safety and performance.

A stereotactic system used by neurosurgeons to more precisely determine where to perform their surgical procedure was intended to be MRI compatible but the older predicate it compared itself to was not, requiring additional performance testing.

It would also help make sure that newer devices reflect more modern technologies and standards that can improve patient care and outcomes. It would help the overall product environment continue to evolve in the direction toward safer, more effective devices.

We aim to efficiently advance beneficial technology to patients, while solidifying FDA’s gold standard for safety. Our goal in focusing on older predicates is to drive sponsors to continually offer patients devices with the latest demonstrated improvements and advances in safety.

RT @jonathanrockoff: .@US_FDA is revamping procedures for clearing medical devices, @TomBurtonWSJ reports. https://t.co/tqBcJnBBcM Will… https://t.co/LI6H5dKuyQ

RT @FDA_Drug_Info: TOMORROW: Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions meeting in Washington, DC.… https://t.co/1ARNfRsm4J

RT @foodsafetygov: Still holding on to those Thanksgiving leftovers? Today is the last day to use them! Can’t let go? Freeze them! Fro… https://t.co/HhspfV4tUn

RT @FDATobacco: REMINDER: FDA will hold a public hearing on youth e-cigarette use and strategies to help them quit on Dec. 5 at the… https://t.co/56FGqxOSjW

RT @SGottliebFDA: THREAD: Federal health officials at #FDA and @CDCgov updated our investigation and advice related to the current E.… https://t.co/JxEzOEWjbh

RT @FDAOncology: We're getting set up for today's #FDAOncology 2nd annual educational workshop for new cancer patient advocates, Par… https://t.co/wmWhCb6CYn

RT @BlumenthalG: First histology-agnostic, pan-tumor New Molecular Entity approval. Another example of a targeted therapy developed using… QT @SGottliebFDA: 1/5 Today the #FDA granted accelerated approval to an oncology drug for adult and pediatric patients that targets a… https://t.co/U9smfjrjPf)