DC Circuit Court strikes down FDA's ban of a device for a specific use, ruling that it amounts to regulating the practice of medicine, a power not granted to the Agency.
#FDA #CircuitCourt @RAPSorg @aami_connect
https://www.enzyme.com/blog/circuit-court-sides-with-rotenberg-against-fda

Tues 7/27, FDA hosts webinar to discuss 2 recent publications @EnzymeCorp featured in blogs - the Draft Guidance Remanufacturing of Medical Devices & the discussion paper for Strengthening Cybersecurity Practices w/ Servicing Medical Devices http://shorturl.at/oJLN0

Draft VALID Act expands FDA authority over IVCTs modified by users, and its phase-in could be < 3 years.

#FDA @RAPSorg @aami_connect #IVDD

https://www.enzyme.com/blog/new-valid-act-phase-in-may-be-as-short-as-three-years

WHO raises several key principles to consider in the evolving regulatory landscape of AI medical devices.

@WHO @FDAcdrhIndustry #artificialintelligence #medicaldevice #machinelearning @RAPSorg
https://www.enzyme.com/blog/who-enters-ai-debate-with-report-on-guiding-principles

Remanufacturers be warned - 21 CFR Part 820 is indeed a part of your life. If a party deliberately or inadvertently improves safety or performance - this may be deemed remanufacturing, including cumulative effects of multiple servicings. #medicaldevices https://www.enzyme.com/blog/fda-cites-record-keeping-inspections-in-remanufacturing-draft

FDA's multi-tiered medical device cybersecurity guidance landscape gets more complex as FDA releases new draft guidance on the servicing and remanufacturing of software in/as medical devices. https://www.enzyme.com/blog/fda-developing-cybersecurity-policy-for-serviced-devices

@RAPSorg @aami_connect #FDA #SaMD #cybersecurity #medicaldevice

New draft EC AI legislation is likely to increase regulatory burden for AI products in the EU.

@RAPSorg #artificialintelligence #machinelearning #SaMD @ASQ #cemarking #medicaldevice

https://www.enzyme.com/blog/eu-draft-legislation-for-ai-may-add-regulatory-hurdles

FDA announces new draft guidance for Section 522 studies, shortening timelines and improving transparency.

@FDAcdrhIndustry @RAPSorg #postmarketsurveillance @ASQ

https://www.enzyme.com/blog/fda-tightens-turn-around-times-for-section-522-studies

One of the difficult parts of risk management is that FDA’s provisions are scattered across several guidances. This blog post summarizes some of the provisions. https://www.enzyme.com/blog/fda-iso-and-the-risk-management-quandary #fda #riskmanagement #medicaldevices

FDA updates draft guidance on medical device products demonstrating electromagnetic compatibility (EMC). #fda #medicaldevices https://www.enzyme.com/blog/fda-electromagnetic-compatibility-requirements-growing

Twitter feed image.

The IMDRF has released its five-year strategic plan for regulatory convergence which includes considerations for cybersecurity and AI, and a single premarket review process for medical devices. https://www.enzyme.com/blog/imdrfs-five-year-plan #AI #healthcare #cybersecurity

Twitter feed image.

FDA’s Safer Technologies Program offers a quicker review process for products that significantly improve the patient risk-benefit profile. https://www.enzyme.com/blog/fda-step-program-offers-expedited-review #fda #digitalhealth

Twitter feed image.

The EU’s Medical Device Coordination Group has updated its policy on remote audits during the COVID-19 pandemic. https://www.enzyme.com/blog/remote-audits-gaining-traction-in-the-era-of-covid-19 #COVID19 #DigitalHealth #COVID19