Graematter, Inc.

A True Regulatory Intelligence Company - Think Intelligence. Think Graematter. #graematter #RegIQ #RIQ #RegIntel

[Graematter, Inc. @GraematterInc]

Proposed rule to shift from 820 to 13485 has arrived! Does anyone believe it will be as easy as it looks in this notice? Once final, only one year to implement! Better get started soon. https://t.co/ym9wqz0LBP #CDRH #FDA #RegIntel #QMS #QSR

[Graematter, Inc. @GraematterInc]

Struggle understanding FDA requirements? Join FREE FDA Conference! Regulatory education from the regulators for the regulated! July 19-23. Separate tracks for drugs, devices, biologics. Agenda here https://t.co/Trwjaebojj #FDA #RegIntel #CDRH #CDER #CBER

[Graematter, Inc. @GraematterInc]

Be warned! Update your https://t.co/CLIkMht4xL info. Long overdue enforcement is here. Letter to Acceleron here. https://t.co/PImyPhf48X Potential monetary penalties, injunction, prosecution for not updating study info. Violation notice flag on study record, too.

[Graematter, Inc. @GraematterInc]

Seriously?! Exempt 83 med devices based only on # of MDRs? HHS proposed this in January. Bad analysis approach! Today FDA rightly says "no" - FR notice explains the faulty analysis well. https://t.co/rvyFnjun8U #CDRH #MedDev #RIQ #RegIntel

[Graematter, Inc. @GraematterInc]

Will CDRH review resources be freed up soon? With so many EUAs, the "no alternatives" criteria may be no longer the case. Good insight by Jeff Shapiro. See the FDA Law Blog post here: https://t.co/MntcDMojlC #FDA #CDRH #RegIntel #RIQ

[Graematter, Inc. @GraematterInc]

CDRH Review delays are now very visible. Resources shifted to battle COVID mean delays in pre-subs & 510(k) reviews. From IVD groups affected last fall, the delays spread to other groups. https://t.co/9Hj3EmeH6Y #CDRH #FDA #MedDevice #RegIntel #RegIQ

[Graematter, Inc. @GraematterInc]

CDRH Review delays are now very visible. Resources shifted to battle COVID mean delays in pre-subs & 510(k) reviews. From IVD groups affected last fall, the delays spread to other groups. https://t.co/9Hj3EmeH6Y #CDRH #FDA #MedDevice #RegIntel #RegIQ

[Graematter, Inc. @GraematterInc]

Prepare yourself for more Breakthrough Device Designation requests! CMS finalizes rule for accelerated coverage. Faster decisions. Coverage up to 4 years. Nice! Fact sheet & FR Notice here: https://t.co/CnkEUYMtl2 #FDA #CMS #CDRH #RegIntel

[Graematter, Inc. @GraematterInc]

FDA inspection issues?! New pre-sub guidance adds meeting for feedback to help prep response. Able to schedule in time?! Hmmm. Also Safer Tech Program (STeP) meetings added. Copy with highlights posted here: https://t.co/ZQMarR6Ufc #FDA #CDRH #RegIntel #RIQ

[Graematter, Inc. @GraematterInc]

Get cheaper drugs from Canada via Trump Exec Order? Not so fast! Canada moves to protect against drug shortages. New regulations will limit exports. https://t.co/ami7QKj4bZ #HealthCanada #drugs #RegIntel

[Graematter, Inc. @GraematterInc]

Guinea pigs everywhere celebrate! Rabbits plan big party! FDA considers alternative approach to testing for <24 hour intact skin contact materials. Open for comments! New draft guidance here: https://t.co/A9MaHj6pw4 #FDA #RegIntel #MedDevices #RIQ

[Graematter, Inc. @GraematterInc]

The strain on CDRH is showing in the data. Review times are up. Numbers cleared trending down. Track with us every week: https://t.co/9Hj3EmeH6Y
#FDA #CDRH #RegIntel #MedDevices

[Graematter, Inc. @GraematterInc]

FDA's CDRH Director Jeff Shuren notes the strain on review resources. Have you seen any slowdowns? https://t.co/uX1hrPNpoX

[Alexander Gaffney @AlecGaffney]

I suspect the amount of pressure the FDA will be under in the coming weeks just went up quite a bit.

[Alexander Gaffney @AlecGaffney]

A Federal Register notice that medical device companies might want to keep an eye on: https://t.co/K5mUlqT74L

Ethylene Oxide is commonly used to sterilize medical devices, and efforts to crack down on its use (for environmental and safety reasons) have resulted in shortages.

[Bakul Patel @_bakulpatel]

Update from FDA on #FDAPrecert on lessons learned and
next steps https://t.co/dKgEbPx87U @FDADeviceInfo #digitalhealth

[Sharon Bishop @RIQatGraematter]

@GraematterInc @AlecGaffney Graematter's historical guidance collection has saved at least one clinical trial/product approval when the old guidance couldn't be located.

[Graematter, Inc. @GraematterInc]

@AlecGaffney That is why we at Graematter have been collecting and keeping guidance (and other documents) for over 20 years.

[Graematter, Inc. @GraematterInc]

The UK exits the EU. New rules begin in January 2020. New things to learn. Processes to change. SOPs to modify. MHRA guidance posted here: https://t.co/FHM7t6xdtg #MHRA #RegIntel #RIQ #BrexitBritain

[Graematter, Inc. @GraematterInc]

Hold on tight! Arms & legs inside the car! Ride is not over yet! The regulatory roller coaster continues for COVID-19 testing. Excellent summary of the twists & turns in FDA's requirements here: https://t.co/Pt9AnFdmRN #COVID19 #FDA #RegIntel #RIQ