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Scott Gottlieb, M.D. @SGottliebFDA
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Assuring the safety of medical products is central to FDA’s consumer protection mission. In today’s #FDA #SUNDAYTWEETORIAL I’m going to talk about FDA’s ambitious new safety goal for medical devices and our 510K reforms that, once implemented, will advance safety and innovation.
We've set a new goal that WE WILL achieve: Ensuring #FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices. This is a top priority. Many have asked me what does that mean? And how will #FDA do that?
First, a little background: #FDA regulates more than 190,000 different medical devices that are manufactured by more than 18,000 companies in more than 21,000 facilities worldwide. We approve, clear or grant marketing authorization to about 12 new or modified devices every day.
Medical devices can go to market only after the #FDA carefully determines that the devices are safe and effective based on valid scientific evidence. This is a decision that takes into consideration whether the device’s benefits outweigh its risks to the patient.
Unfortunately, #FDA can’t always know the full extent of benefits and risks of every device at time of market entry. Sometimes new signals emerge after a product is used by clinicians and a broad patient population. Even reasonably sized premarket trials can’t tell us everything.
Once a device is on the market, we monitor adverse event reports that are submitted to the #FDA from manufacturers, health care providers, and the general public on devices which may have malfunctioned or caused a serious injury or a death. These are examples of safety signals.
We also review published studies, order post-market studies in certain cases and inspect manufacturing facilities. But these are “passive tools” that either rely on device users reporting to us, which can result in underreporting, or information flowing in long after the fact.
We need to create an active surveillance system for medical devices that relies on real-world evidence and timely receipt of robust safety info. That’s why since 2012 #FDA has been moving to put in place an infrastructure that can identify potential problems in near real time.
We began by implementing a unique device identification system (UDI). Each device is given a unique code for its label that allows it to be tracked through distribution and use. These identifiers are stored in a public database – there are now 1.5 million device records in all.
We’re now collaborating on the creation of a national system for gathering real-world evidence: the National Evaluation System for health Technology (NEST). It will leverage a wide range of data systems w/ info from patient registries, payor claims and electronic medical records.
A public-private enterprise, the NESTcc (Coordinating Center) has already created an early data network by entering into agreements with 12 organizations representing more than 195 hospitals and almost 4,000 outpatient clinics with access to more than 495 million patient records.
It will soon launch pilot programs testing the use of patient registries and claims data to evaluate total joint and knee replacement surgery, different wound closure techniques and the safety of intervertebral body fusion devices for spinal conditions bit.ly/2ORWmG3.
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.
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.
Our Women’s Health Technologies-CRN bit.ly/2L4Tqsx 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
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 bit.ly/2OU7wKX
And we’ve warned about energy-based vaginal rejuvenation devices go.usa.gov/xPAw6. 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.
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.
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 bit.ly/2Hpc3l9.
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 go.usa.gov/xPAGK.
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 go.usa.gov/xPAGU
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 go.usa.gov/xPsQ6. It highlights FDA’s targeted, risk-based enforcement approaches to infusion pumps, automated external defibrillators and radiation therapy devices
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.
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
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