Medical Devices Law and Regulation Answer
- ISBN-10
- 140241837X
- ISBN-13
- 9781402418372
- Category
- Law
- Pages
- 1014
- Language
- English
- Published
- 2012
- Publisher
- Practising Law Inst
- Authors
- Suzan Onel, Karen Becker
Description
The regulation of medical devices has grown increasingly complex since the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FDCA) were introduced in 1976. Medical Devices Law and Regulation Answer Book 2013 walks you through the current regulatory requirements and describes every aspect from pre-market requirements for specific types of devices to post-market regulation and ongoing government enforcement and investigation. With over 30 contributors from a variety of major law firms and consulting firms specializing in medical device work, Medical Devices Law and Regulation Answer Book 2013 provides practical guidance on how to handle every day questions on a wide variety of topics as well as what issues are likely to arise and how to avoid them. The breadth of coverage of this new publication is illustrated by the chapter titles provided below: Overview of Medical Device Regulation in the U.S. Clinical Studies of Investigational Devices Device Premarket Submissions Devices with Unique Issues Combination Devices, Radiological Devices, Restricted Devices, Customer Devices, Device Software In Vitro Diagnostic (IVD) Devices The Quality System Regulation Device Facility Inspections Post Market Considerations International Considerations Enforcement and Government Investigations Regarding Medical Devices Interacting with FDA Intellectual Property Considerations for Medical Device Companies Fraudulent and Abusive Practices in the Reimbursement for Medical Devices HIPAA s Impact on the Medical Device Manufacturing Community Continuing Medical Education (CME) and Industry-Supported Scientific Activities Litigation, Product Liability, and Preemption Licensing, Product Development and Commercialization FDA Criminal Enforcement Overlapping Jurisdiction with other Agencies and Law Enforcement Entities Commonly Used Acronyms"
Get the book
Other editions
Similar books
-
Property Law: Rules, Policies, and Practices
By Joseph William Singer, Bethany R. Berger, Nestor M. DavidsonSee also Country Community Timberlake Village v. HMW Special Utility District of Harris, 438 S.W.3d 661 (Tex. Ct. App. 2014) (holding that a neighboring ...
-
Entertainment Law and Business
By William D. Henslee, Elizabeth HensleeAfter Justin Timberlake exposed Janet Jackson's pierced nipple on national television for 9/16ths of a second, the FCC received over 540,000 complaints.
-
The Common Law in Colonial America: Volume III: The Chesapeake and New England, 1660-1750
By William E. NelsonVolume III: The Chesapeake and New England, 1660-1750 William E. Nelson ... Decision of Law, Surry County Ct. 1673/74, in Eliza Timberlake Davis ed., ...
-
The Indiana State Constitution
By William P. McLauchlanE. Edwards v. California, 314 U.S. 160 (1941), 66 Edwards v. Housing Authority of City of ... Timberlake, 148 Ind. 38,46 N.E.339 (1897), 69,70 Graves v.
-
Child Support Guidelines: Interpretation and Application
By Laura W. MorganFitzgerald, 4.08[B][2], 5.05[D] Fitzgerald v. ... Mastrapa-Font, 7.03[A][3] Fontaine, In re, 5.05[D] Fontenette v. ... Frost, 5.05[A] Formato v.
-
Maritime Fraud and Piracy
By Paul ToddThe sole remedy is avoidance, however; damages cannot be claimed under s. ... 17, it places a great deal of power in the hands of insurance companies to ...
-
Principles of the Carriage of Goods by Sea
By Paul ToddNormally, a mate«s receipt would later be given up for a bill of lading, ... they necessarily prejudice the rights of those who deal in the goods ...
-
Maryland Employment Law
By Stanley Mazaroff, Todd Horn27 257 U.S. 184, 42 S. Ct. 72, 66 L. Ed. 189 (1921). ... 38 Argensinger, “Right to Strike”: Labor Organization and the New Deal in Baltimore, 78 MD . HIST .
-
Contract Law in New Zealand
By Stephen Todd, Jeremy Finn704 Contract and Commercial Law Act 2017, s. 80. 705 Leith v. Gould [1986] 1 NZLR 760. It is not clear how a New Zealand court would deal with a case such ...
-
Tort Law in New Zealand
By Stephen Todd... to meet the reasonable expectations of claimants about how the corporation should deal with them, by, inter alia, ... 7 Treaty of Waitangi Act 1975, s.