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Inside Medical Devices | Covington & Burling LLP | Updates on FDA Device Regulation & Health Information Systems | insidemedicaldevices.com Reviews
https://insidemedicaldevices.com
Inside Medical Devices provides updates & legal insight for pharmaceutical, medical & surgical equipment, including diagnostic & health information systems.
insidemedicaldevices.com
21st Century Cures Act Passes the House: Contains Key Provisions Related to Medical Devices | Inside Medical Devices
https://www.insidemedicaldevices.com/2015/08/03/21st-century-cures-act-passes-the-house-contains-key-provisions-related-to-medical-devices
Covington and Burling LLP. From Covington and Burling LLP. 21st Century Cures Act Passes the House: Contains Key Provisions Related to Medical Devices. 21st Century Cures Act Passes the House: Contains Key Provisions Related to Medical Devices. August 3, 2015. Posted in FDA Device Regulation,. If enacted, the Act would make changes to the standards and process for premarket review of new devices, the regulation of health software, and a number of other key medical device topics. The Senate is currently w...
FDA | Inside Medical Devices
https://www.insidemedicaldevices.com/tag/fda
Covington and Burling LLP. From Covington and Burling LLP. FDA Publishes Two Draft Guidances on Next Generation Sequencing Technology. July 18, 2016. Posted in FDA Device Regulation. FDA Releases Draft Guidance on Dissemination of Patient-Specific Information by Device Manufacturers. July 5, 2016. Posted in FDA Device Regulation,. FDA Releases Draft Guidance on the Use of EHRs in Clinical Investigations. June 17, 2016. Posted in FDA Device Regulation,. Medical Information Technology,. On May 17, 2016, FD...
FDA to Focus on “Complementary” Diagnostics in Addition to Companion Diagnostics | Inside Medical Devices
https://www.insidemedicaldevices.com/2015/07/09/fda-to-focus-on-complementary-diagnostics-in-addition-to-companion-diagnostics
Covington and Burling LLP. From Covington and Burling LLP. FDA to Focus on Complementary Diagnostics in Addition to Companion Diagnostics. FDA to Focus on Complementary Diagnostics in Addition to Companion Diagnostics. July 9, 2015. Posted in FDA Device Regulation. Elizabeth Mansfield, Deputy Director for Personalized Medicine in the Office of In Vitro Diagnostics and Radiological Health at FDA, stated at a recent conference. The agency announced in two draft guidance documents. FDA is increasingly focus...
FY 2016 Medical Device User Fees Announced | Inside Medical Devices
https://www.insidemedicaldevices.com/2015/08/06/fy-2016-medical-device-user-fees-announced
Covington and Burling LLP. From Covington and Burling LLP. FY 2016 Medical Device User Fees Announced. FY 2016 Medical Device User Fees Announced. August 6, 2015. Posted in FDA Device Regulation. On August 3, 2015, the FDA announced. The medical device user fee rates and payment procedures for fiscal year ( FY ) 2016, which applies from October 1, 2015 through September 30, 2016. The Agency will raise user fee rates by over 4%. Panel-track supplement: $196,041. 180-day supplement: $39,208. US Government ...
Florida Adopts Daubert Standard for Expert Testimony | Inside Medical Devices
https://www.insidemedicaldevices.com/2013/06/17/florida-adopts-daubert-standard-for-expert-testimony
Covington and Burling LLP. From Covington and Burling LLP. Florida Adopts Daubert Standard for Expert Testimony. Florida Adopts Daubert Standard for Expert Testimony. June 17, 2013. Posted in Products Liability. On June 4, 2013, Florida’s Governor signed into law a bill. Amending Florida’s evidence code, replacing the. Standard, which had previously governed the admissibility of expert testimony in Florida, with the. The testimony is based upon sufficient facts or data;. Fla Evid. Code 90.702....Inter...
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Telehealth | Covington eHealth
https://www.covingtonehealth.com/tag/telehealth
Covington and Burling LLP. From Covington and Burling LLP. The Proposed Medicare Telehealth Parity Act of 2015 Would Expand Medicare Reimbursement for Telehealth Services. August 5, 2015. Summary Report of European Commission’s mHealth Consultation Published. January 27, 2015. Posted in Data Security,. The European Commission has finally published its summary of 211 responses to its mobile health ( mHealth ) consultation. The summary and original responses to the consultation have been made available...
Health Data | Covington eHealth
https://www.covingtonehealth.com/category/health-data
Covington and Burling LLP. From Covington and Burling LLP. Subscribe to Health Data RSS Feed. UK Government Considering New Patient Data Security and Research Consent Standards, Sanctions. August 11, 2016. Posted in Big Data,. EU Data Protection,. ONC Report to Congress Identifies Gaps in Oversight of Privacy and Security of mHealth Technologies and Health Social Media. July 28, 2016. Posted in Cybersecurity,. HIPAA and Data Privacy,. Significant HIPAA Fine Follows Business Associate’s Stolen iPhone.
Preemption Archives | Drug & Device Law
https://www.druganddevicelawblog.com/category/preemption
The definitive source for intelligent commentary on the law that matters for drug and device cases. Briefing Underway in Appeal of Half-Billion-Dollar Verdict in Pinnacle MDL. March 9, 2017. This post comes from the Cozen O’Connor side of the blog. We’ve been following the Pinnacle MDL closely through the last two bellwether trials, starting with the news coming out of the second bellwether trial. Below are some of the key issues, along with a quick description of the defense’s arguments:. Brief at 20-29...
“Regulatory Causation” Roundup | Drug & Device Law
https://www.druganddevicelawblog.com/2017/01/regulatory-causation-roundup.html
The definitive source for intelligent commentary on the law that matters for drug and device cases. Raquo; Regulatory Causation Roundup. January 10, 2017. Last week’s Westlaw search (that’s one way we find the cases we discuss in the Blog) brought a blast from the past a case almost three years old showed up discussing and rejecting expert testimony about so-called regulatory causation. Since we’d only touched upon this type of expert opinion once. We thought we’d take a more in-depth look at this concept.
Accolades for Medical Law Perspectives | Drug & Device Law
https://www.druganddevicelawblog.com/awards
The definitive source for intelligent commentary on the law that matters for drug and device cases. Drug and Device Law Blog has received numerous accolades since its inception, including being named as one of the ABA Journal’s. 100 favorite legal blogs on numerous occasions since 2008, and one of LexisNexis Top 25 Blogs. Our awards and accolades are listed below. ABA Journal’s BLAWG 100 Honoree. Online FNP’s 100 Quality Resources for Nursing and Medical Law. The 2010 HAL Medical Blog Awards. More on Mis...
Lipitor MDL Court Grants Pfizer’s Omnibus Summary Judgment Motion: No Evidence of Causation | Drug & Device Law
https://www.druganddevicelawblog.com/2017/01/lipitor-mdl-court-grants-pfizers-omnibus-summary-judgment-motion-no-evidence-of-causation.html
The definitive source for intelligent commentary on the law that matters for drug and device cases. Raquo; Lipitor MDL Court Grants Pfizer’s Omnibus Summary Judgment Motion: No Evidence of Causation. Lipitor MDL Court Grants Pfizer’s Omnibus Summary Judgment Motion: No Evidence of Causation. By Rachel B. Weil. January 9, 2017. Rulings]. The Court will then promptly set a schedule in each case for identifying expert witnesses. Dosages Less Than 80 mg.: General Causation. Expert Testimony on General Causat...
Rachel B. Weil, Author at Drug & Device Law
https://www.druganddevicelawblog.com/author/rweil
The definitive source for intelligent commentary on the law that matters for drug and device cases. Rachel B. Weil. Subscribe to Rachel B. Weil's Posts. Southern District of Indiana Excludes Plaintiffs’ Experts in Hernia Mesh Case. By Rachel B. Weil. March 2, 2017. Last week, in. Bowersock, et al. v. Davol, Inc. and C.R. Bard, Inc. The plaintiffs’ first expert, a general and gastrointestinal surgeon who used the defendants’ patch in his own practice, reviewed the patch explanted from the decedent’s exhum...
china market overview
http://www.bridgesmedic.com/chinamedicaldevicenews.html
Bridges Medic Consulting (BMC). China and U.S. Medical Device Growth Bridge. TAVR China Educational Training and Exchange Program. The investment trends report of the 17 segment disease In recent 20 years. China Medical Device Industry Highlights in 2014. China 13th Five-Year Plan of Healthcare Market. Seveal Key Factors about China Medical Device industry. Companies in non-healthcare industry in China are eager to get into healthcare sector. A Brief History of Breast Cancer. China Rehab O&P PT. Under th...
“A Causal Relationship Need Not Have Been Proved” | Drug & Device Law
https://www.druganddevicelawblog.com/2010/04/causal-relationship-need-not-have-been.html
The definitive source for intelligent commentary on the law that matters for drug and device cases. Raquo; A Causal Relationship Need Not Have Been Proved. A Causal Relationship Need Not Have Been Proved. April 8, 2010. How does plaintiff-side stealth preemption work? 20180(e). In either case, the FDA’s regulatory regime isn’t constrained by common-law concepts of defect or legal cause. That’s what the FDA wants. That’s what we want the FDA to be able to do. But what the FDA can demand as a regul...818 F...
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Inside Medical Devices | Covington & Burling LLP | Updates on FDA Device Regulation & Health Information Systems
Covington and Burling LLP. From Covington and Burling LLP. CFDA and CMDE Issue Draft Guidance on Medical Devices for Rare Diseases. February 22, 2018. Posted in Device Regulation in China. On February 6, 2018, the China Food and Drug Administration (CFDA) and its Center for Medical Device Evaluation (CMDE) issued a draft guidance. FCC Considers a Waiver Request for Medical Imaging System. February 12, 2018. Posted in Federal Communications Commission,. On February 9, 2018, the FCC released a Public Notice.
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