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Laws, regulations and rules subtopic

 

Articles

1-87 out of 87 article(s)
Title Author Type Date Words
Newsletter For Leaders In The Medical Device Industry - November 2009. Nov 17, 2009 2786
Device Industry reps say 510(k) process is ok. Nov 1, 2009 920
Coping with change: medical device regulatory experts provide perspectives of what might take place under the new FDA leadership. Weaver, Allison Nov 1, 2009 3452
Clinical trial disclosure: a medtech software expert provides proven technology strategies for manufacturers. Tadikonda, Satish Nov 1, 2009 1162
Regulatory Reform: In Brief. Oct 14, 2009 530
There Was Movement At The Station: The Australian Consumer Law Reforms Are Being Enacted Into Law. Oct 13, 2009 1237
Research and Markets: Medical Device Development: Regulation and Law, All New Edition is an Essential Resource for the Novice or Veteran Medical Device Regulatory Affairs Professional. Sep 21, 2009 417
Prescription Drug And Medical Device Promotion Through Social Media: Complying With FDA Regulations. Buckley, Maria Aug 27, 2009 875
Research and Markets: The Medical Device Market: Ireland. May 7, 2009 429
New Mass. rules may require upgrade to existing systems. Langdon, Mark; Datta, Meenakshi May 1, 2009 1926
Massachusetts Issues Final "Gift Ban" Regulation Regarding Pharmaceutical And Medical Device Manufacturer Conduct. Mar 25, 2009 2100
Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process. Feb 1, 2009 582
Doctors reject drug-pusher favors; State guidelines for dispensing drug marketing money discussed. Jan 18, 2009 922
Plan for 2009: Learn from 2008; the "big 3" violations. Dumas, Tim Jan 1, 2009 894
Massachusetts enacts new law, Chapter 111N "pharmaceutical and medical device conduct". Nov 6, 2008 1719
"Curved" And "Straight" Are Equivalent Under The Doctrine Of Equivalents. Oct 13, 2008 630
FDA seeks regulation of DNA tests: medical device makers might face greater scrutiny from agency. Chambers, Heather Sep 29, 2008 586
Presentation of an Overview of the Vietnamese Medical Issues and Regulations for Medical Devices and Drugs. Sep 8, 2008 263
Discover How to Enter China's Expanding Medical Device Market: Including a Guide to New Regulations, Opportunities and Case Studies. Sep 8, 2008 197
New FDA Final Rule Amends The Changes Being Effected (CBE) Regulations. Caffrey, Sharon Aug 28, 2008 1106
United States: CMS Lacks Oversight of Millions of Medicare Dollars for Durable Medical Equipment, According to GAO Report. Aug 5, 2008 288
United States: Senate Passes Durable Medical Equipment Bidding Delay. Jul 19, 2008 163
United States: Veto override puts Medicare medical equipment program on hold. Jul 18, 2008 101
Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices. Jul 7, 2008 215
Proposed legislation could impact liability exposure. Jul 1, 2008 544
Cost recovery and the future of the medical device regulation program in Canada. Alpert, Sheri Jun 22, 2008 3422
Democrats preparing liability legislation. Jun 17, 2008 843
Lilly, Zimmer back transparency on M.D. perks. May 20, 2008 746
Canada Proposes Tough New Product Safety Laws. May 8, 2008 1261
Sore spot. Brief article May 1, 2008 292
New Stark Law Proposal Would Ease Traps For Unwary. Abram, Jonathan Apr 30, 2008 1694
Eighth Circuit Reverses Certification Of Nationwide Class Of Uninjured Medical Device Recipients. Apr 21, 2008 967
Does Riegel v. Medtronic, Inc. Affect You? Case overview Apr 17, 2008 579
Communications effort focuses Congress, media on preemption. Apr 1, 2008 396
Testimony Confirms OIG's Ongoing Focus On Vendor Relationships With Physicians. Mar 19, 2008 877
Senator queries FDA and spinal disk maker. Mar 11, 2008 644
Feeling the pressure. Delporte, Christopher Mar 1, 2008 545
Supreme Court decision will impact orthopedics: Senate panel questions the industry about relationships with physicians. Mar 1, 2008 1031
FDA proposes guidance for dissemination of information in unapproved uses of medical products. Feb 26, 2008 771
Supreme Court upholds federal pre-emption of state device liability laws. Feb 26, 2008 710
Ruling complicates debate on FDA's competence. Feb 26, 2008 830
President Bush proposes about $97 million more for medical product safety, user fees for generics. Mashaw, Rebecca Feb 12, 2008 966
Proposed Rule Amending Regulations Governing Supplemental Applications Proposing Labeling Changes For Approved Drugs, Biologics, and Medical Devices. Feb 4, 2008 1419
Compliance With FDA And SEC Disclosure Requirements For Medical Device Makers: Standard Operating Procedures Can Help. Gray, Elizabeth Jan 23, 2008 617
Washington state urges FDA to ban unproven medical devices. Jan 15, 2008 392
Asymtek and YESTech Enable Medical Device Manufacturers to Meet Regulatory Requirements for Traceability and Validation for Fluid Dot Dispensing. Jan 7, 2008 397
Your signature, please: approving design outputs: failure to have a good procedure in place for signatures and approvals can slow you down. Vogel, David A. Jan 1, 2008 3037
Xlear, Inc., Orem, UT, has achieved ISO 9001:2000 and ISO 13485:2003 certification for quality management, which is the recognized international standard for medical device regulations around the world. Nov 1, 2007 86
Effects of medical device legislation on innovation within Australian manufacturing companies. Svistounov, Alexander; Adams, Karen; Kestell, Colin; Munday, Kristin Oct 1, 2007 3608
6-item 483 received by IRB for consent and correspondence records. Pickett, Joseph Report Oct 1, 2007 755
Medicare Hospital Inpatient Rule: New Policy For Recalled/Replaced Devices. Sep 7, 2007 656
The Regulations Governing the Authorisation and Marketing of Medical Devices in Sweden Are in Line with the EU, Although Marketing Practices Are Tightly Regulated. Aug 29, 2007 305
A Changing Regulatory Environment for Healthcare Products in Sub-Saharan Africa. Aug 8, 2007 713
House approves medical device identification requirement: improved safety is primary goal. Mayberry, Peter; Franken, Jessica Aug 1, 2007 1148
FDA warns Medtronic over its drug-infusion pumps. Brief article Jul 30, 2007 250
BiMo inspection FOIA log. Brief article Jun 1, 2007 197
FDA announces recommendations to reauthorize MDUFMA. Apr 23, 2007 841
Lawyers focus on lens solution lawsuits. Porter, Rebecca Mar 1, 2007 686
Judge rejects preemption in heart device case. Sileo, Carmel Feb 1, 2007 766
FDA proposes safeguards against BSE by barring some cattle products from drugs, biologics, devices. Jan 16, 2007 528
Biophan Announces Congressional Approval of $1 Million Allocation in New Government Grants in Support of MYO-VAD(TM) Cardiac Recovery System. Sep 27, 2006 819
Medical devices? New regulatory opportunities abound for drugs and supplements in Europe. Gruenwald, Joerg Sep 1, 2006 969
New Regulations For Advanced Medical Communication Devices - Part 2. Jul 24, 2006 736
Biophan Announces Key Senate Approval of $400,000 for the MYO-VAD Cardiac Assist Device; Potential Funding to Benefit Joint Effort Between the Rochester Heart Institute at Rochester General Hospital and MYOTECH. Jul 12, 2006 873
Biophan Announces $1 Million Allocation in New Government Grants in Support of MYOTECH's MYO-VAD(TM); Plus $309,000 in Government Funded Equipment Provided in Support of Biophan Research. Jun 29, 2006 730
Caution urged in using experimental tools to evaluate MCI. Wendling, Patrice May 1, 2006 587
Study says AWP law will shake up market. Henry, John Jan 23, 2006 281
2005 legislation: eliminating mercury in health care setting. Jan 1, 2006 738
FDA action. Brief Article Sep 12, 2005 87
California court allows delayed discovery of medical device claim. Jurand, Sara Hoffman Aug 1, 2005 598
CMS Issues Draft Guidance on Medicare's National Coverage Determination Process. Mar 31, 2005 1819
Health & Safety: UK Developments. Nov 17, 2004 1239
FDA approval preempts medical-device injury claims, Third Circuit says. Porter, Rebecca Oct 1, 2004 1039
The FTA's Impact On Generic Pharmaceuticals And The PBS: Much Ado About Nothing? Sep 20, 2004 1876
CDC guide to PPE: remove gloves first: work practices, sequence are important. Jul 1, 2004 591
Nurses still stuck with unsafe needles: conventional devices still widely used. Jul 1, 2004 689
EndoMed hit with no FDA-approved IDE, no PMA. Gould, Dawn Brief Article Jul 1, 2003 153
How FDA regulations and injury litigation cripple the medical device industry. (Law & Justice). Homsy, Charles A. Jul 1, 2003 3797
FDA hits ventilatory recorder manufacturer with failure to establish design control procedures. Gould, Dawn Jun 1, 2003 511
Office of combination products. (FYI). Brief Article Apr 1, 2003 117
FDA bill should speed up approvals: user fees will fund faster reviews of new medical devices. (Biotech). Webb, Marion Oct 28, 2002 556
News Briefs. Nov 1, 1999 1443
New Medicare rules to simplify billing; more IVDs exempt from FDA premarket review. Szabo, Joan Jun 1, 1998 704
FDA Reporting Requirements For Medical Devices. Jan 31, 1996 363
FDA 510(k) Medical Device Guidance Manual released. Sep 18, 1995 390
Selecting instruments with an eye to CLIA. Lifshitz, Mark S.; De Cresce, Robert P. Aug 1, 1992 2470
Approval processes different for devices and drugs. McGivney, William T. Jul 1, 1990 1038

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