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The article informs that India's Central government has constituted a committee for framing/preparing new drugs, cosmetics and medical device laws, and mentions eight-member panel, headed by Drug Controller General of India V.G. Somani, is scheduled to submit a draft document.

The article discusses how American agencies such as the Centers for Medicare & Medicaid Services and the U.S. Department of Veterans Affairs went on paying to implant the HeartWare Ventricular Assist Device (HVAD), in patients even though federal inspectors had found problems. It reports while taxpayer dollars continued to flow to the original device maker, HeartWare, and then to the company Medtronic, for 7 years while the issues raised in the warning letter remained unresolved.

The article discusses a statement made by the Indian Union Minister for Chemicals & Fertilizers and Parliamentary Affairs, Mr. Ananth Kumar at the 9th Medical Technology Conference in New Delhi in 2016 in which he said that promotion and regulation of medical devices should go hand in hand.

The article reports that 2020, the Indian Ministry of Health and Family Welfare published the Medical Device Rules, 2020 requiring the registration of all non-notified medical devices.

The article discusses how the U.S. Food and Drug Administration (FDA) approves medical devices using an expedited process where device manufacturers must prove a product is similar to an approved product. Topics include how the FDA warned doctors to stop using laparoscopic power morcellators after discovering they may spread uterine cancer, whether the approval system fails to determine device safety, and morcellator devices from Cook Urological Inc. and Karl Storz Endoscopy-America Inc.

The article discusses the European Parliaments' rejection of a proposal that electronic cigarettes (e-cigarettes) be regulated as medical devices. Topics addressed include possible regulation of e-cigarettes by the U.S. Food and Drug Administration (F.D.A.), a lack of data on the health effects of e-cigarettes, and restrictions on advertising for e-cigarettes and sales to young people.

The article focuses on the pending approval by the U.S. Food and Drug Administration on the catheter-based imaging and ultrasound systems of San Diego, California-based Volcano Corp. According to its president and chief executive officer (CEO) Scott Huennekens, FDA's complicated and delayed approval have affected the economy of the region. In response, medical device companies have been routinely launching products at first in overseas where it can easily deal with foreign regulatory agencies.

Two letters to the editor are presented in response to articles in previous issues including the Congress Blog post "Medical devices: The risks of cutting corners" in the May 5, 2016 issue, and "DOJ files lawsuit against North Carolina over bathroom law" in the May 9 issue.

Reports on the possible final approval of the bill on medical device user fees by the U.S. Senate. Agreement between the House and Senate on the bill; Provisions of the bill; Changes implemented to the bill by the House; Benefits of the bill for small businesses.

Reports on the delay in the final approval proceedings of the U.S. Congress on a bill to create a system of user fees to speed up Food and Drug Administration review times for medical devices. Provisions of the bill; Reasons for the delay in the final approval of the bill.

Reports on the approval of bill on lifesaving medical devices by the U.S. House Energy and Commerce Committee. Significance of the bill; Key feature of the bill.

The article reports on the introduction of a bill by the Republican-led Congress to repeal the medica device tax.

Two questions and answers are presented related to legal counseling such as the visitation rights of a husband after a divorced and a class action lawsuit in dealing with a medical device.

The article discusses the passage of reportedly stricter legislation regarding the regulatory approval and marketing of medical devices in the European Union as of October 2013, focusing on analyses of several medical device-related scandals involving breast and hip implants.

The article offers news briefs related to business in the U.S. as of September 21, 2013 including the sale agreement of Smithfield Foods, the selling of a stake in Italian soccer club F. C. Internationale to Indonesian investor Erick Thohir, and the required tracking codes in medical devices.

The article reports on the clarification of the U.S. House Energy and Commerce Committee, and the Republicans with regards to smartphones, applications, and tablets, whether they are considered as medical devices and if they are affected by the medical device tax.

The article reports that the House and Senate of the U.S. Congress are planning to work in collaboration to renew the user fee agreements of the Food and Drug Administration, for the availability of safe drugs and medical devices to the public.

The article reports that Democrat legislators of the House Energy and Commerce Committee have asked medical journal editors' view on Republican's proposed medical device regulations in the U.S.

The article discusses initiatives by the U.S. Food and Drug Administration (FDA) to establish stricter regulations for medical devices.

The article offers information on the proposed bill called Medical Device Safety Act of 2009. It states that the proposed bill could remove the law that protects device makers of getting sued by injured patients due to device malfunction, and it is believed that if the bill will be pass, it will not take effect on the Orange County. It also mentions that the law will affect the device market industry because of investors might not invest on a new product.

The article reports on the passage of the Food and Drug Administration (FDA) Amendments Act of 2007 that supports the resources to ensure more thorough review of drugs and devices in the U.S. According to U.S. Department of Health & Human Services Secretary Michael Leavitt, the bill is an important step forward in ensuring the safety of drugs and medical devices. Billy Tauzin of the Pharmaceutical Research and Manufacturers of America stated that the law will provide the resources the FDA needs to promote the public health.

The article reports that U.S. House Energy and Commerce Health Subcommittee Chairman Frank Pallone has revealed that he might seek further regulation of the single-use devices that are reused under a sterilization procedure known as reprocessing. The Advanced Medical Technology Association has condemned the reuse of devices meant for one-time use.

The article reports that medical device makers have opposed to a provision in the Senate-passed version of the U.S. Food and Drug Administration (FDA) reauthorization bill that stipulates the makers to conduct studies on the effects of their product on children if they want its approval. Mark Leahey, executive director of the Medical Device Manufacturers Association, said that the provision would create a disincentive to make products available for children.

The article focuses on violations of federal research regulations found in the work of Randall K. Wolf, a University of Cincinnati heart surgeon, whose studies have been used to promote the experimental use of a heart device in patients.

The article reports that the legislation on ultrasound machines which was authored by U.S. Assemblyman Ted W. Lieu has passed the Assembly and would prohibit the sale or distribution of ultrasound machines to anyone other than a licensed medical professional. The bill is intended to block parents-to-be from using the devices to initiate home sonograms, which would possibly harm the development of a fetus.

Reports that the discussion between the U.S. House and Senate negotiators over the inclusion of drug and device user-fee packages in the bioterrorism package continued on May 20, 2002 owing to differences over a proposal to allow complex medical devices to be reviewed by U.S. nongovernment officials. Condition for the inclusion of device user-fees in the bill.

Reports on the agreement of the United States (US) Supreme Court to decide whether the US Food and Drug Administration's (FDA) regulation of medical devices pre-empts a state lawsuit charging Buckman Co. with fraudulently winning approval to market a device. Overview of the case; Claims of the plaintiffs against Buckman; Justification of Kenneth Geller, an attorney representing Buckman.

Focuses on the bipartisan package approved by the US Congress on November 9, 1997 to speed up the Food and Drug Administration's approval of drugs and medical devices. Provisions of the bill on the financing and cuts in the review time of the FDA; Requirements for the circulation of articles on unapproved uses of drugs; Objections of the medical-device industry about the legislation.

Focuses on a bill to increase the government's review for many medical devices and drugs in the United States. Detailed information on the bill, which outlines the authority of the Food and Drug Administration; Attempts of a filibuster from Senator Edward M. Kennedy, Democrat of Massachusetts.

Informs about the approval given to Medtronic Incorporated's heart defibrillator by the Food and Drug Administration. Details of the device; Impact of the approval on the prices of its shares; Information about other manufacturers of defibrillators.

Reports on the filing of Bausch & Lomb Incorporated with the Food and Drug Administration to seek approval to market its soft contact lens material.

Reports on the approval by the Food and Drug Administration to EP Technologies Incorporated to market its cardiac ablation system. Information about the EP device.

Reports on Senators Joseph Lieberman's and John McCain's contention that the defeat of federal product liability legislation, against the safe supply of medical devices now awaiting President Clinton's veto, will put many sick people at risk. Terms of bill; Claims by Senators that bill bars damage recoveries against biomaterials suppliers; How the absence of liability encourages suppliers to be reckless with materials.