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PMA Final Decisions for January 2013

March 20, 2013 12:00 am | News | Comments

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis. A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.

FDA Puts Highest-Risk Category on Symbios Infusion Pump Recall

March 19, 2013 4:10 pm | News | Comments

Symbios Medical Products recalled certain lots of its GOPump Elastomeric Infusion PumpKit systems over concerns that a component that moderates the flow of medicine from the pump may fail and cause an overdose. The FDA placed Class I status on the recall, a category reserved for issues which "may cause serious adverse health consequences, including death," according to an agency notice.

Consumer Information on: Argus II Retinal Prosthesis System - H110002

March 11, 2013 12:00 am | News | Comments

The Argus II Retinal Prosthesis System is the first implanted device to treat adults with severe retinitis pigmentosa. The System has three parts: a small electronic device implanted in and around the eye, a tiny video camera attached to a pair of...


Hauser's FDA Rx: The FDA needs an NTSB

March 10, 2013 10:25 pm | News | Comments

Dr. Robert Hauser hopes to push a major change at the FDA, looking to shift the monitoring of medical devices and drugs that are already on the market from the FDA to an independent entity. Hauser, a long-time patient safety advocate and vocal FDA critic, is aiming to sell Capitol Hill on a new structure for the U.S. healthcare regulation system akin to how the nation deals with transportation safety.

Draft Guidance for Industry and Food and Drug Administration Staff - Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex

March 8, 2013 12:00 am | News | Comments

The purpose of this guidance is to make recommendations on the appropriate language to include in the labeling of a medical product to convey that natural rubber latex was not used as a material in the manufacture of the product or product container...

FDA Updates Guidance on Pulse Oximeter Applications

March 7, 2013 9:29 am | News | Comments

The FDA issued new guidance governing premarket notification submissions for pulse oximeters. The new guidelines apply to all 510(k) submissions for the non-invasive blood oxygen level and pulse rate measuring devices. In the guidance, published March 4, the FDA specified new rules for identifying, testing and assuring safety for the systems.

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

March 7, 2013 12:00 am | 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 | 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 | 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...

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 | 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 | 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 | 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 | 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 | 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.

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 | 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 | 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 | 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 | 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 | 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 today.

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 | 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 | 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 | 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 | 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 | 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 | 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...

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