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

Our Women’s Health Technologies-CRN https://t.co/BwZ072Kere is providing evidence on device therapies unique to women - uterine fibroids, pelvic floor disorder, female sterilization and long-acting reversible contraception. Part of our new $3 million for the NEST is going to this https://t.co/ty15eeDVEh

I mentioned patient registries as an important source of safety signals for the NEST. The #FDA currently supports a series of Coordinated Registry Networks (CRN) which link different real-world data sources to generate clinical evidence about medical products from patients.

NEST was established with #FDA seed money and an additional $3 million in September and partial funding through industry user fees, but more funding is needed. For the NEST to be fully functional, the President’s FY 2019 budget includes a request for an additional $46 million.

But after we ID an issue, then what? Our Medical Device Safety Plan includes the NEST as well as exploring reg. options to speed safety mitigations, spurring innovation, and advancing cybersecurity and a total product lifecycle (TPLC) approach to safety https://t.co/inKKf5iClp. https://t.co/EN5irdUTHX

Combining UDI with NEST (including patient registry info) provides a robust medical device safety net for patients through better data and will allow us to achieve our ambitious goal of being consistently first in identifying device safety signals. This new system a top priority.

Amid safety concerns, we strengthened our regulation of surgical mesh 2 years ago, issuing an order to up-classify mesh for pelvic organ prolapse (POP), requiring mfrs to submit premarket approval (PMA) applications and get approval to continue marketing https://t.co/QYGZZpOQy0.

The National Breast Implant Registry, launched in September, may help us identify risk factors for implant complications, such as a patient’s own medical history, the specific type of operation, the type of implant used and how it interacts w/other devices https://t.co/z9MritSUf2 https://t.co/WgZStYZHp5

And we’ve warned about energy-based vaginal rejuvenation devices https://t.co/nza9QkMGiq. After reaching out to 7 manufacturers marketing their devices for unapproved/uncleared uses, all have changed their websites to remove claims associated with these uses.

In February we’ll convene an advisory committee to discuss the safety and effectiveness of mesh for POP repair and provide an opportunity for the #FDA to hear directly from the public, including patients, about their experiences and we will consider additional regulatory actions.

Other examples of our response to safety concerns are cited in our new Device Enforcement and Quality Report https://t.co/Vg2D8xXMVH. It highlights FDA’s targeted, risk-based enforcement approaches to infusion pumps, automated external defibrillators and radiation therapy devices https://t.co/GnQ4blaKwR

Manufacturers stopped marketing mesh for highest risk indication, transvaginal posterior POP repair and only 3 mesh products remain on market for another indication, transvaginal repair of anterior compartment prolapse while #FDA evaluates their PMA data https://t.co/eCG1Pbwc3Z

RT @califf001: Moving in the right direction on devices. I hope that health systems, especially academic health systems, will rise to the… QT @SGottliebFDA: We want to continually push the market for new devices - and predicates on which device clearances are based - in t… https://t.co/TuFu394BC6)

RT @califf001: Go NEST! Success with a prospective real world system not only give us much needed safety info with numerators & denominato… QT @Fleurence: NESTcc is hard at work improving access to timely and useful evidence for medical devices. NESTcc was established… https://t.co/FHA2zOYQYP)

We'll have updates on our progress in these areas soon. We'll advance other new policies shortly. Taking these and other steps will enable the #FDA to make decisions about devices based on the best available evidence and allow us to continue to improve patients' health and safety https://t.co/OIqNyfI0qm

And this week, we’ll announce our intent to pursue the most significant modernization of the 510(k) clearance pathway in a generation so #FDA can bring treatments to patients that reflect advances in technology, safety, and the capabilities of a new generation of medical devices.

We want to continually push the market for new devices - and predicates on which device clearances are based - in the direction of incorporating more modern features that improve safety and performance as we learn more about science and technology that can improve patient safety.

@sarahdespres @NESTccMedTech Check out this helpful #FDA advice on how long to keep leftovers. Enjoy today! More than three days may be pushing it @sarahdespres https://t.co/8bSnJcfJ6b

RT @SGottliebFDA: We've set a new goal that WE WILL achieve: Ensuring #FDA is consistently first among the world’s regulatory agencie… https://t.co/WVUe2gmnkB

The 510(k) program has been strengthened and refined in many ways, especially in recent years, as the FDA’s Device Center has made a systematic, concerted effort to improve the program’s performance, predictability, efficiency and safety.

We believe in merits of 510(k) process, but also believe it must be modernized to reflect advances in technology, safety, capabilities of newer devices. It’s time to fundamentally modernize an approach first adopted in 1976 c/w Medical Device Safety Action we issued in April 2018

Our Women’s Health Technologies-CRN https://t.co/BwZ072Kere is providing evidence on device therapies unique to women - uterine fibroids, pelvic floor disorder, female sterilization and long-acting reversible contraception. Part of our new $3 million for the NEST is going to this https://t.co/ty15eeDVEh

I mentioned patient registries as an important source of safety signals for the NEST. The #FDA currently supports a series of Coordinated Registry Networks (CRN) which link different real-world data sources to generate clinical evidence about medical products from patients.

NEST was established with #FDA seed money and an additional $3 million in September and partial funding through industry user fees, but more funding is needed. For the NEST to be fully functional, the President’s FY 2019 budget includes a request for an additional $46 million.

But after we ID an issue, then what? Our Medical Device Safety Plan includes the NEST as well as exploring reg. options to speed safety mitigations, spurring innovation, and advancing cybersecurity and a total product lifecycle (TPLC) approach to safety https://t.co/inKKf5iClp. https://t.co/EN5irdUTHX

Combining UDI with NEST (including patient registry info) provides a robust medical device safety net for patients through better data and will allow us to achieve our ambitious goal of being consistently first in identifying device safety signals. This new system a top priority.

Amid safety concerns, we strengthened our regulation of surgical mesh 2 years ago, issuing an order to up-classify mesh for pelvic organ prolapse (POP), requiring mfrs to submit premarket approval (PMA) applications and get approval to continue marketing https://t.co/QYGZZpOQy0.

The National Breast Implant Registry, launched in September, may help us identify risk factors for implant complications, such as a patient’s own medical history, the specific type of operation, the type of implant used and how it interacts w/other devices https://t.co/z9MritSUf2 https://t.co/WgZStYZHp5

And we’ve warned about energy-based vaginal rejuvenation devices https://t.co/nza9QkMGiq. After reaching out to 7 manufacturers marketing their devices for unapproved/uncleared uses, all have changed their websites to remove claims associated with these uses.

In February we’ll convene an advisory committee to discuss the safety and effectiveness of mesh for POP repair and provide an opportunity for the #FDA to hear directly from the public, including patients, about their experiences and we will consider additional regulatory actions.

Other examples of our response to safety concerns are cited in our new Device Enforcement and Quality Report https://t.co/Vg2D8xXMVH. It highlights FDA’s targeted, risk-based enforcement approaches to infusion pumps, automated external defibrillators and radiation therapy devices https://t.co/GnQ4blaKwR

Manufacturers stopped marketing mesh for highest risk indication, transvaginal posterior POP repair and only 3 mesh products remain on market for another indication, transvaginal repair of anterior compartment prolapse while #FDA evaluates their PMA data https://t.co/eCG1Pbwc3Z

RT @califf001: Moving in the right direction on devices. I hope that health systems, especially academic health systems, will rise to the… QT @SGottliebFDA: We want to continually push the market for new devices - and predicates on which device clearances are based - in t… https://t.co/TuFu394BC6)

RT @califf001: Go NEST! Success with a prospective real world system not only give us much needed safety info with numerators & denominato… QT @Fleurence: NESTcc is hard at work improving access to timely and useful evidence for medical devices. NESTcc was established… https://t.co/FHA2zOYQYP)

We'll have updates on our progress in these areas soon. We'll advance other new policies shortly. Taking these and other steps will enable the #FDA to make decisions about devices based on the best available evidence and allow us to continue to improve patients' health and safety https://t.co/OIqNyfI0qm

And this week, we’ll announce our intent to pursue the most significant modernization of the 510(k) clearance pathway in a generation so #FDA can bring treatments to patients that reflect advances in technology, safety, and the capabilities of a new generation of medical devices.

We want to continually push the market for new devices - and predicates on which device clearances are based - in the direction of incorporating more modern features that improve safety and performance as we learn more about science and technology that can improve patient safety.

@sarahdespres @NESTccMedTech Check out this helpful #FDA advice on how long to keep leftovers. Enjoy today! More than three days may be pushing it @sarahdespres https://t.co/8bSnJcfJ6b

RT @SGottliebFDA: We've set a new goal that WE WILL achieve: Ensuring #FDA is consistently first among the world’s regulatory agencie… https://t.co/WVUe2gmnkB

The 510(k) program has been strengthened and refined in many ways, especially in recent years, as the FDA’s Device Center has made a systematic, concerted effort to improve the program’s performance, predictability, efficiency and safety.

We believe in merits of 510(k) process, but also believe it must be modernized to reflect advances in technology, safety, capabilities of newer devices. It’s time to fundamentally modernize an approach first adopted in 1976 c/w Medical Device Safety Action we issued in April 2018