A big thank you to @DavidUrbachMD and @chaim_bell for both their mentorship and help in crafting this viewpoint.

Our paper analyzes the ancestry of Transvaginal Mesh ( as a case study to show the importance of increasing transparency into these 510(k) ancestries to improve the safety of medical devices on the market.

What do you want to know?.

・Predicates that have since been recalled by manufactures due to safety concerns.・Predicate creep in which the modern device is substantially different from the original predicate in its ancestry. additional issues that undermine the value of substantial equivalence claims.

Device ancestries are like a family tree🌿 for medical devices and they trace the iterative 510(k) clearances that lead to modern devices. An analysis of these ancestries can uncover questionable relationships, including substantial equivalence claims to:.

The 510(k) pathway, with its increased efficiency, has since become the primary premarket review pathway for medical devices. Iterative 510(k) clearances over the past 45 years have led to complex device relationships and ancestries.

The 510(k) solved congress's dilemma. Instead of requiring manufactures to provide new safety and efficacy data for incremental iterations of their device, they can instead show their new device is substantially equivalent to a previously cleared device termed a predicate

・Low risk devices that require no premarket review ✅.・Medium risk devices cleared through the 510(K) pathway❓.・High risk devices that require an extensive premarket approval review🔎. So what is the 510(k) pathway❓.

Congress was challenged with establishing a pathway that could improve safety without introducing a barrier to medical device innovation. The result was the FDA's tiered review pathway that stratifies medical devices into 3 risk categories:.

The FDA's medical device approval process was established in 1976 in response to serious harm caused by medical devices (see Dalkon Shield IUD .

Excited to share a piece we published in @JAMASurgery on the importance of postmarket surveillance for medical devices. A brief #tweetorial ↓ on what medical device ancestries are and why they play an important role in patient safety.

Thanks for the opportunity to be a part of this important effort!.

An important read.

Thanks for the thread! A clear gap in regulation if nobody is assessing for value before a new drug reaches the market. Can certainly see how this drives up healthcare costs without improving the outcome needle.

RT @NishilaMehta: Excited to share what me and @jeremyrosh have been working on over the past little while- a detailed, operational guide t….

Working with @NishilaMehta to share a Toronto based clinic's processes and protocols in response to #COVID19. Hoping this helps other clinics adopt a virtual first model -- join the live document and share your perspective!.

A great student led initiative to consolidate information resources and updates on COVID-19

RT @DanielDJLee: CALLING ALL FAMILY PHYSICIANS: we have lots of @uoftmedicine med students volunteering to call seniors to prevent senior i….

what challenges are you having transitioning to virtual care? We are working on more comprehensive implementation guides and FAQs to help you make the switch!.

RT @NishilaMehta: Great hearing @zakkohane of @HarvardDBMI kick off @uoftmedicine’s ML in Medicine symposium, followed by a panel with @Lau….

This has been a long time coming and will create fertile ground for innovations in health delivery.