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Class I Medical Device Recall: Ad-Tech Medical Instrument Corporation, Macro Micro Subdural Electrodes

March 7, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

There is a concern the microelectrodes are defective and may cause injury to the brain. As a result, there is the potential for scraping (abrasion) of brain tissue and for broken pieces to remain in the brain tissue when the physician removes the...

FDA Releases Draft of Sunshine Law Financial Disclosure Guidelines

March 6, 2013 2:29 pm | by Mass Device | News | Comments

The FDA published a draft of the Sunshine Act financial disclosure guidelines that will take full effect by August 1, 2013. The 35-page document details all physician-relationship rules companies will have to follow when applying for marketing applications with the FDA.

Data Standards and Terminology Standards for Information Submitted to CDRH

March 5, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The Center for Devices and Radiological Health (CDRH) encourages manufacturers to use data and terminology standards in pre-market submissions and post-market reports for medical devices. The FDA can review and analyze data and information more quickly...

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Types of Communication During the Review of Medical Device Submissions - Draft Guidance for Industry and Food and Drug Administration Staff

March 4, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

During the review of a premarket submission, FDA?s practice has been to communicate with applicants1 through either a formal communication (such as a Major Deficiency Letter or an additional information request issued through a letter, or through phone...

AdvaMed Fights to Keep User Fees Out of Sequester Cuts for FDA

February 26, 2013 4:20 pm | by Mass Device | News | Comments

The medical device industry doesn't want user fees paid by industry to be included in a series of cuts slated for the FDA's budget this week. The federal watchdog agency will have $210 million, or about 5.1% of its $4.1 billion budget, cut from its 2013 budget March 1 as a result of sequestration, the bargain between the White House and Congress.

FDA Issues Draft Guidance on Distinguishing Medical Device Recalls from Product Enhancements

February 25, 2013 2:38 pm | by Mass Device | News | Comments

The FDA issued draft guidance for medical device companies on distinguishing between a recall and a product enhancement that doesn't need 1, saying it recognizes that "continuous improvement activities" "often have a favorable impact on medical device safety and are part of ongoing efforts to design and manufacture devices that meet the needs of the user and patient."

Who Will Win The Battle For Tougher Medical Device Regulations, the European Commission or Device Manufacturers?

February 25, 2013 12:04 pm | by GlobalData | News | Comments

Faulty breast implants at risk of bursting, and defective metal-on-metal hip prostheses, both raising grave concerns about patient health and long-term toxicity, have plagued the reputation of the medical device industry over the past year, states a GlobalData healthcare analyst.

Class I Medical Device Recall: Lumenis Limited, Lumenis VersaCut Tissue Morcellator

February 25, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Lumenis Limited is recalling certain models of VersaCut Morcellator devices to correct its labeling. There is a potential for air embolisms to occur if the aspiration tubing is hooked up backwards to the aspiration control box housing. This product may cause serious adverse health consequences, including death.

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Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements - Draft Guidance for Industry and Food and Drug Administration Staff

February 22, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Defects or performance failures of marketed medical devices can pose serious risks to public health. Recalls serve both to correct a defect in current and future devices and to notify users of potential risks and steps to minimize the impact of device...

Silicone Gel-Filled Breast Implants

February 21, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Silicone gel-filled breast implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells. Silicone gel-filled breast implants are approved for breast augmentation in women...

FDA 510(k) Review Times Improving, Annual Analysis Shows

February 20, 2013 2:37 pm | by Emergo Group | News | Comments

Review times for medical device 510(k) premarket notifications by the US Food and Drug Administration improved somewhat in 2011 after several years of lengthening review times, according to a new analysis of publically available FDA data by Emergo Group.

Evaluation of Automatic Class III Designation (De Novo) Decision : K124065 added

February 20, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the "De Novo" classification option as an alternate pathway to classify certain new devices that had automatically been placed in Class III due to lack of a predicate.

Sen. Elizabeth Warren Will Seek Industry's Help on Medical Device Tax Repeal

February 19, 2013 3:47 pm | by Mass Device | News | Comments

Newly elected Sen. Elizabeth Warren (D-Mass.) is looking to talk with medical device makers about ongoing efforts to repeal the medical device tax, although she has yet to sign her name to a new Senate bill to do just that, she told MassDevice.com today.

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Jonathan S. Helfgott, FDA Compliance Officer for Center for Drug Evaluation & Research (CDER), to Address PHT Corporation U.S. PRO & eCOA Congress

February 19, 2013 1:55 pm | by The Associated Press | News | Comments

BOSTON & GENEVA--(BUSINESS WIRE)--Feb 19, 2013--PHT Corporation announced that Jonathan S. Helfgott, FDA Compliance Officer for CDER, within the office of Scientific Investigations, will present: “FDA Perspective on the Compliant Use of ePRO Instruments to Support FDA Studies” at the 17 thPRO...

FDA Consumer Update: Kids Have Problem With Medical Product?

February 19, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Consumers can play a critical role in helping the Food and Drug Administration (FDA) assure children's access to safe medical products. Reporting to FDA such adverse events as unexpected, serious side effects, accidental exposure, and product quality...

Draft Guidance for Industry and Food and Drug Administration Staff - Providing Information about Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act

February 15, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Section 302 of Title III of the Food and Drug Administration Amendments Act of 2007 (FDAAA), created Section 515A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e). Section 515A requires submitters to FDA of premarket approval..

Accreditation and Reaccreditation Process for Firms under the Third Party Review Program: Part I - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Reviewers

February 14, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), requires FDA to establish and publish criteria to reaccredit and deny reaccreditation to third parties under section 523 of the FD&C Act (21 U.S.C. 360m) to perform premarket review of class I and eligible class II premarket notification [510(k)] submissions. 

FDA Seeks Comment on Device Detention Rules

February 8, 2013 3:20 pm | by Mass Device | News | Comments

The FDA proposes to renew the inspection protocols for banned medical devices and is seeking more - make that any - comment from the public. Having pursued less than 1 device detention annually over the past several years, the FDA is proposing once again to extend and renew the program that collects information about medical devices, submitting the proposed changes to the Office of Management & Budget for approval.

TorkLaw Responds to FDA Warning Letter to St. Jude Medical Regarding Defective Heart Device; Now Representing Patients in 15 States

February 8, 2013 1:32 pm | by Bio-Medicine.Org | News | Comments

LOS ANGELES , Feb. 9, 2013 /- Product liability law firm TorkLaw continues to pursue litigation against St. Jude Medical on behalf of injured patients and their families. In December 2011, the Food and Drug Administration issued a Class 1 recall for the St. Jude Medical Riata leads after many adverse events were being reported in patients. Studies showed that t...

Senate Follows House in Launching Medical Device Tax Repeal Bill

February 7, 2013 6:01 pm | by Mass Device | News | Comments

Lawmakers deliver a 1-2-punch in launching parallel medical device tax repeal bills in the House of Representatives and then the Senate just a day apart. A bipartisan group of Senators today released a bill that would repeal the 2.3% medical device tax, closely following a parallel bill released in the House of Representatives yesterday.

Class I Medical Device Recall: Hamilton Medical, Inc., HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower

February 7, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

During ventilation of small pediatric patients with high airway resistance and low lung function, there may be unexpected high internal oxygen consumption by HAMILTON-T1 ventilators with software versions 1.1.2 and lower.

Medical device tax: Paulsen re-boots repeal bid with new bill, Senate measure to follow

February 6, 2013 12:33 pm | by Mass Device | News | Comments

Reps. Erik Paulsen and (R-Minn.) and Ron Kind (D-Wis.) introduce a bill to repeal the medical device tax, with a companion bill expected to follow in the Senate. Rep. Erik Paulsen (R-Minn.) filed a new bill aimed at repealing the 2.3% medical device excise tax today, following up on his commitment to do away with the levy.

Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate

February 6, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The FDA has developed this draft guideline as the special controls to support the reclassification of the temporary mandibular condyle reconstruction plate (TMCRP) from class III to class II (special controls), which is being issued as a proposed order..

Webinar - What a UDI System can do for Patients and Consumers

February 6, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Successful UDI implementation offers a number of potential benefits for patients and consumers, including faster detection of safety concerns associated with specific devices, more efficient communication between providers and patients regarding...

House majority leader Eric Cantor decries the medical device tax

February 5, 2013 4:27 pm | by Mass Device | News | Comments

House majority leader Eric Cantor's (R-Va.) comments on the medical device tax remind that the fight for repeal isn't over. House majority leader Eric Cantor (R-Va.) hasn't forgotten about the the medical device tax, a measure he once called a "draconian" burden on the U.S. medtech industry.

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