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Lenz, Principal Medical Device Regulation Expert —It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. [read post]

FDA Law Blog - https://www.thefdalawblog.com/

Texas Appeals Court Affirms Order with No Geographic Restriction on Children’s Residence

29 Apr 2023, 3:37 pm by Kelly McClure

Lenz v. [read post]

Texas Divorce Attorney Blog - https://www.mcclure-lawgroup.com/blog

Surprise! Another 512(f) Claim Fails–Bored Ape Yacht Club v. Ripps

29 Apr 2023, 7:13 am by Eric Goldman

Crosley-Corcoran * 17 USC 512(f) Is Dead–Lenz v. [read post]

Technology & Marketing Law Blog - http://blog.ericgoldman.org/

27th Annual BTLJ-BCLT Symposium: From the DMCA to the DSA: Keynote and copyright interactions

7 Apr 2023, 10:51 am by Rebecca Tushnet

Avoids problems of regulatory arbitrage. 230 v. [read post]

43(B)log - http://tushnet.blogspot.com/

You’re a Fool if You Think You Can Win a 512(f) Case–Security Police and Fire Professionals v. Maritas

1 Apr 2023, 8:05 am by Eric Goldman

Crosley-Corcoran * 17 USC 512(f) Is Dead–Lenz v. [read post]

Technology & Marketing Law Blog - http://blog.ericgoldman.org/

512(f) Plaintiff Must Pay $91k to the Defense–Digital Marketing v. McCandless

5 Dec 2022, 10:46 am by Eric Goldman

Crosley-Corcoran * 17 USC 512(f) Is Dead–Lenz v. [read post]

Technology & Marketing Law Blog - http://blog.ericgoldman.org/

CDRH’s Plan to De-risk the Medical Device Valley of Death

21 Nov 2022, 12:56 am by Kurt R. Karst

CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027). [read post]

FDA Law Blog - https://www.thefdalawblog.com/

Anti-Circumvention Takedowns Aren’t Covered by 512(f)–Yout v. RIAA

4 Oct 2022, 7:12 am by Eric Goldman

Crosley-Corcoran * 17 USC 512(f) Is Dead–Lenz v. [read post]

Technology & Marketing Law Blog - http://blog.ericgoldman.org/

11th Circuit UPHOLDS a 512(f) Plaintiff Win on Appeal–Alper Automotive v. Day to Day Imports

18 Aug 2022, 9:49 am by Eric Goldman

Crosley-Corcoran * 17 USC 512(f) Is Dead–Lenz v. [read post]

Technology & Marketing Law Blog - http://blog.ericgoldman.org/

Impact Litigation in Action: Building the Caselaw Behind a Win for Free Speech

13 Jul 2022, 4:23 pm by Cindy Cohn

Arriba Soft), and some focusing on fair use (Lenz v. [read post]

Deeplinks Blog - https://www.eff.org/deeplinks

Court Mistakenly Thinks Copyright Owners Have a Duty to Police Infringement–Sunny Factory v. Chen

15 Mar 2022, 10:36 am by Eric Goldman

Crosley-Corcoran * 17 USC 512(f) Is Dead–Lenz v. [read post]

Technology & Marketing Law Blog - http://blog.ericgoldman.org/

Another 512(f) Claim Fails–Moonbug v. Babybus

6 Mar 2022, 7:11 am by Eric Goldman

Crosley-Corcoran * 17 USC 512(f) Is Dead–Lenz v. [read post]

Technology & Marketing Law Blog - http://blog.ericgoldman.org/

Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions

2 Jan 2022, 12:00 am by Kurt R. Karst

The guidance assesses credibility using key concepts from FDA-recognized standard ASME V&V 40 Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices. [read post]

FDA Law Blog - https://www.thefdalawblog.com/