Update Dec 20, 05

Endologix Announces Limited Voluntary Recall of Powerlink System Delivery Catheter

Endologix, Inc. announced that it is voluntarily conducting a limited product recall of selected Powerlink® System delivery catheters marketed in the U.S., which are used to deliver the Company's minimally invasive treatment for abdominal aortic aneurysms (AAA). This action does not include the Powerlink stent grafts that have been implanted in patients. In addition, it does not include the large diameter 34 mm Powerlink System being evaluated under an investigational device exemption or Powerlink Systems sold outside of the U.S., as both of these Systems utilize a different delivery catheter. Endologix has notified the U.S. Food and Drug Administration (FDA) Los Angeles District Office. The company is initiating this action as a result of its ongoing comprehensive analysis of three recent reports of tip separation from the catheter sheath inner core during procedures. In two of the cases the Powerlink stent graft was successfully deployed and in one case the separation occurred before the device could be positioned for deployment.

Update Dec 19, 05

Class 1 Recall: Baxter Healthcare Corp. Meridian® Hemodialyis (HD) Instrument

FDA has classified Baxter Health Corp’s recall of its Meridian Hemodialyis Instruments as a Class I recall. Baxter had initiated the recall in September 28th, 2005 after reports of hemolysis (broken blood cells) related to kinks in the blood tubing sets used with the Meridian. Till now, there have been reports of one death and one serious injury associated with this problem.

This recall doesn’t affect Meridian instruments currently on the market. According to the new labeling that Baxter released, only one of the two channels of the two channel clips should be used.

Baxter’s letter to Meridian’s customers can be found at http://www.baxter.com

For more details on this update, please refer to: http://www.fda.gov/cdrh/recalls/recall-092805.html

Update Dec 9, 05

Draft Guidance for Industry and FDA - Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens.’’ This draft guidance provides guidance on the types of information and data to consider when preparing or reviewing premarket submissions for nucleic acid based in vitro diagnostic devices for the detection of microbial pathogens. This draft guidance replaces ‘‘Review Criteria for Nucleic Acid Amplification based in vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms’’ that was issued in June 1993. The current document reflects changes in the technologies available for nucleic acid detection, and expanded use in clinical laboratories.

The FDA is accepting written or electronic comments on this draft guidance till March 8, 2006.

For more information pertaining to this update, refer to: http://www.fda.gov/OHRMS/DOCKETS/98fr/05-23746.pdf

To view the Draft Guidance, refer to: http://www.fda.gov/cdrh/oivd/guidance/1560.pdf

Update Dec 6, 05

Boston Scientific Announces Worldwide Recall of Stainless Steel Greenfield® Vena Cava Filters Manufactured Before March 10, 2004

Boston Scientific Corporation announced that it is voluntarily recalling all Stainless Steel Greenfield® Vena Cava Filters with 12Fr Femoral Introducer Systems manufactured before March 10, 2004. This recall does not affect vena cava filters that have been implanted in patients.

This recall includes only the Stainless Steel Greenfield® Vena Cava Filter with 12Fr Femoral Introducer Systems manufactured prior to March 10, 2004. All unused devices with a “use before date” prior to March 2007 are to be returned to Boston Scientific. The total number of devices involved in this recall is estimated at 18,000.

The Company is initiating this recall because of reports of detachment at the bond between the carrier capsule and the outer sheath of the filter’s delivery system during the implant procedure. If the carrier capsule should detach during an implantation procedure, there is a risk of cardiac and pulmonary embolization. Potential adverse events include serious patient injury or death.

For more information on this update, please read the following link:

http://www.fda.gov/oc/po/firmrecalls/bostonsci12_05.html

Update Dec 5, 05

FDA Approves First Test to Screen for West Nile Virus

FDA today announced the approval of the first West Nile Virus (WNV) blood test to screen donors of blood, organs, cells and tissues. The Procleix WNV Assay, developed by Gen-Probe Inc., and marketed by Chiron Corporation, detects viral genetic material (ribonucleic acid or RNA). This new test will help protect patients who receive blood and other such products against West Nile infection.

WNV is typically transmitted to humans by mosquito bites. Over twenty thousand people have been infected by the virus causing over seven hundred fatalities. In 2002, it was found that this virus can be transmitted in blood. Thirty cases which include nine deaths have been attributed to the spread of the virus through a blood transfusion procedure.

This test is a result of the combined efforts of the health authorities and the industry to come up with a test that would screen out carriers of this virus and hence maintain a safe blood supply.

More information can be found at: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01266.html

Update Nov15, 05

Draft Guidance - Special Control for Latex Condoms with and without Spermicidal Lubricant

FDA is proposing some regulatory changes relating to condoms and their classification and labeling. Changes proposed include, amending the identification sections of the classification regulations for condoms with and without spermicidal lubricant to change the wording “venereal disease” to “sexually transmitted diseases”. FDA is also proposing to add classification sections to each of the regulations, segregating the subset of condoms in each classification that are made of latex. Finally, FDA is proposing to designate a special controls guidance document with labeling recommendations for latex condoms.

Condoms have been classified as Class II device and hence require mandatory performance standards. However, because of various complexities, FDA hadn’t announced any performance standards for condoms or most other Class II devices. However, after the passage of the Safe Medical Devices Act of 1990, FDA has the authority to enact special controls through which Class II devices can be regulated.

FDA has, after an extensive study come up with Special Controls for Condoms that when followed would provide adequate safety and effectiveness information for consumers to make an informed choice.

The labeling recommendations in the draft special controls guidance are intended to provide information to users of latex condoms with and without spermicidal lubricant. FDA through this guidance is recommending that manufacturers to inform users about the extent of protection provided by condoms against unintended pregnancies and also against various types of sexually transmitted diseases (STDs). In addition the labeling should mention about possible risks associated with exposure to N-9 contained in the spermicidal lubricant of some condoms.

This draft guidance is neither final nor is it in effect at this time. FDA is welcoming written or electronic comments till February 13, 2006.

For more information, please review the following documents:

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-22610.pdf and

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-22611.pdf

Update Nov 11, 05

Guidance for Industry and Staff - Pilot Program to Evaluate Proposed Globally Harmonized Alternative for Premarket Procedures

The FDA on Nov 10, released Guidance on the voluntary premarket review program - Summary Technical Documentation (STED pilot). The guidance was originally issued in the Federal Register on June 26, 2003.

The STED Pilot is being implemented by the CDRH and is limited to Premarket Approval (PMA) and 510(k) submissions. The program will assess the feasibility of a proposed internationally harmonized format and content for receiving PMA and 510(k) applications. The guidance provides a list of device types that will be considered for submission under this program. However, device classes that are not mentioned in list will be considered on a case-by-case basis. The “Draft STED document” (this is the common name, actually title on document is quite long!) should be referenced to submit applications under this program. Manufacturers should consult with the FDA to find out if they are eligible to participate in this pilot program.

FDA plans to keep the pilot active until the agency has received adequate number of submissions to evaluate the program.

For more details on this guidance, please refer to: http://www.fda.gov/cdrh/ode/guidance/1347.pdf

The draft STED document can be viewed at: http://www.ghtf.org/sg1/inventorysg1/pd_sg1_n011r17.pdf

Update Nov 8, 05

Classification of Low Energy Ultrasound Wound Cleaner and Issuance of Related Guidance

FDA recently classified the Low Energy Ultrasound Wound Cleaner as a Class II device and issued a guidance document for such devices. This classification and the subsequent guidance document are in response to a petition filed by Celleration, Inc. in April 2004 for their Celleration MIST Therapy System TM. Celleration’s device was the first of its kind and hence had to go through the 513(f)(1), 513(f)(2) classification route.

The guidance is effective immediately. However, FDA will accept any comments that it receives in regards to this guidance to consider if any amendments to the document are required.

The Guidance is available on the internet at CDRH’s website and can also be obtained by fax. For more details on the Classification or on the guidance document, please refer to the following Federal Register announcements –

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-22068.pdf and

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-22069.pdf

Update Nov 8, 05

Issuance of Draft Guidance for Tinnitus Marker Devices

The FDA recently released a draft guidance for the regulation of Tinnitus Marker Devices. These devices are regulated as Class II devices. The guidance covers topics including the content and format of the 510(k) application, scope, device description, risks to health, preclinical and clinical testing and labeling.

For the complete guidance, please refer to the following document:

http://www.fda.gov/cdrh/ode/guidance/1555.pdf

Update Oct 19, 05

FDA Issues Device Cost Analysis Report entitled, - FY 2003 and FY 2004 Unit Costs for the Process of Medical Device Review-

FDA recently released a report, compiled by Dr. Dale Geiger that documents the unit costs that FDA incurs in reviewing selected premarket applications. Eight types of applications have been considered over the combined years of FY 2003 and 2004. Investigational Device Exemption (IDE) applications, 510(k)s for CDRH, Premarket approval (PMA) applications, PMA supplements, investigational New Drug (IND) applications, 510(k)s for CBER, Biologic License Applications (BLAs) and BLA Supplements have been used in deriving the unit costs.

The following tables summarize the findings, with $k/unit giving the cost of review (/unit) for each type of application

CDRH	$M	Final actions	$K/unit
IDE	61.1	467	131.9
510(k)	107.7	8043	13.4
PMA	71.5	127	563.0
Supplements	19.0	1291	14.7

CBER	$M	Final actions	$K/unit
IDE/IND	4.4	35	126.3
510(k)	4.2	139	30.4
PMA/BLA	16.2	13	1244.2
Supplements	3.2	877	3.7

Costs incurred due to the following activities were considered: Direct review and laboratory components, indirect review and support components, and center-wide costs. For details on the methodology used, please refer to the following link: http://www.fda.gov/cdrh/mdufma/fy2003-4costs.html

The above estimated costs are not the "true" costs and hence should only be used as a benchmark for future comparisons. FDA workloads and resources fluctuate from year to year and hence would the unit costs.

These findings confirm that the user fee program doesn’t recover the full costs associated with premarket application review. For example, in FYs 2003 and 2004, the fees for an original PMA were $154,000 and $206,811 respectively. The estimated unit cost, however, for the review of such a PMA during the FYs 03 and 04 combined time period was approximately $560,000.

Update Oct 18, 05

United States Marshals Seize Violative Infusion Pumps Made by Baxter Healthcare Corporation

The US District Court for the Northern District of Illinois, at the instance of the FDA, has issued a warrant for seizure of three types of infusion pumps manufactured by Baxter Healthcare Corporation.

Previous FDA inspections revealed that the firm failed to follow medical device manufacturing requirements. FDA alleges that none of the seized infusion pumps were manufactured under the proper controls and the Colleague pumps have a design defect that many cause the pumps to stop and shut down during infusion therapy. FDA had issued Warning letters to Baxter and had given the company an opportunity to correct the violations. However, Baxter failed to take appropriate actions and instead notified the public of the potential heath hazards associated with these products.

The seized products are: SYNDEO PCA Syringe Pumps, Colleague Volumetric Infusion Pumps, and Colleague CX Volumetric Infusion Pumps. Four thousand SYNDEO and Colleague infusion pumps were seized by the US Marshals from a Baxter warehouse, though no products were seized from healthcare facilities or individual users. Health care facilities can continue to use these pumps, with the aid of instructions that Baxter provided previously, but should be aware of the potential problems, especially in when the pump is being used in a life-saving function.

For details on this story, please visit the following link: http://www.fda.gov/bbs/topics/news/2005/new01242.html

Update Oct 7, 05

Plan B - Victim to a Politicized FDA - We Hope Not!

In the battle between science and politics concerning Barr pharmaceutical’s controversial “morning after” pill, politics seems to have won the latest round. And this is when many people think there were no grounds for the contest to start in the first place. Last month, FDA’s newly appointed Commissioner Lester M. Crawford indefinitely deferred a decision to allow over-the-counter sales of the emergency contraception drug Plan B, by opening the issue for public discussion and comment, with no timeline for making a definitive decision either way.

Plan B is a pill (containing the synthetic hormone levonorgestrel) for emergency contraception. It is used to reduce the chances of pregnancy after unprotected sex. It works by stopping the release of an egg from the ovary and may also prevent the fertilization of an egg and prevent the egg from attaching to the uterus in case of fertilization. It can be used to prevent pregnancies only, and hence is not useful against existing pregnancies.

FDA approved Plan B in July 1999 as a prescription medication. However, many people felt that the medication served its purpose best as an over-the-counter product. Studies have shown that the pill is effective 95% of the time if taken within 24 hours of unprotected sexual intercourse and 75% to 89% if taken within 24 to 72 hours of the incident. Thus, the earlier the pill is taken the better the chances of avoiding a pregnancy. Since, most such incidents take place on weekends or in the evening when the health care practitioner’s office is closed, selling it by prescription isn’t the ideal situation and might lead to pregnancies that could have been avoided had it been sold over the counter. The American College of Obstetricians and Gynecologists (ACOG) estimates that making emergency contraception widely available (as OTC) could prevent about 2 million pregnancies annually and about 500,000 abortions per year.

An FDA advisory committee meeting in December 2003 had sent out an unequivocal message. It had voted 28-0 in favor of the drug being safe and had 24 members voting in favor of (with four against) switching the pill from prescription to over-the-counter status. Even the FDA has, in the past, publicly acknowledged that Plan B is safe. Mr. Crawford, in his confirmation hearing, acknowledged “The Science part is generally done,” “We’re just now down to what the label will look like.”

In a rare move however, the FDA went against the council of the advisory committee and the findings of its own scientists, and in May 2004, rejected Barr’s application to sell the drug over the counter. According to the FDA, the company failed to provide enough information about how well girls younger than 16 understood the drug’s label and whether they might engage in riskier sex if the drug was easily available.

Barr then submitted an amended application in July 2004 requesting FDA to allow over-the-counter sale of the pill for women 16 years and older only and remain as prescription for those below that age. Even this apparently is not good enough for the FDA, which in its latest statement expressed its present inability to regulate a medication that would have dual status, i.e., over the counter or prescription, based on age, citing fuzzy legal and regulatory precedents in this case.

Expressing anguish at this latest development, many people have complained that the agency had enough time on hand to workout a solution for this so called regulatory dilemma it faces. “I am disappointed that FDA waited until this late hour to address a legal question that could and should have been resolved months ago,” Sen. Edward Kennedy, D-Mass., said in a statement. In addition, these are not entirely unchartered waters for the FDA, it having had past experience with restricted over-the-counter sales of nicotine and tobacco.

Under federal regulations, the Food and Drug Administration was required to reach a decision on Plan B by January. As the months passed and there was no activity from the FDA, two Democratic senators who support abortion rights, Hillary Rodham Clinton of New York and Patty Murray of Washington, pledged to block any vote on President Bush's nomination of Crawford to become agency commissioner unless the FDA made a decision on the pill, for or against. The senators relented in July after the secretary of health and human services, Michael Leavitt, promised that a decision would be made by Sept. 1. My Crawford, in his confirmation hearing promised the two senators that a decision would be made.

By indefinitely delaying a decision on the application, Mr. Crawford, seems to have gone back on his words. Many critics’ feel that by rejecting an application that has met all FDA requirements, the agency has succumbed to the influence of ‘moral’ and anti-abortion lobbies when it is has been charged to make decisions solely based on scientific and legal grounds.

This latest decision, or rather indecision from the FDA led to the resignation of Susan Wood, the director of the FDA’s Office of Women’s health. “I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled.” She further said that “There’s fairly widespread concern about FDA’s creditability” among agency veterans as a result. According to Wood, the final decision was not made in FDA’s usual manner, but “at the commissioner level……where most if not all of the professional staff were excluded.”

Opponents of Plan B over-the-counter status hailed Crawford’s decision, saying easier access to emergency contraception may encourage teenage sex. Groups opposing OTC status include the American Association of Pro-Life Obstetricians and Gynecologists and Concerned Women for America, a public policy organization. According to them, since birth control pills, which contain lower doses of progestin, are available only by prescription, how can Plan B, which has a much higher dose of the same synthetic hormone be available over-the-counter. Contrary to well established scientific evidence, many opponents even regard the morning after pill as an abortion medicine.

Other opponents contend that broader access to the pill leads to a higher incidence of sexually transmitted infections (STIs). A Swedish study published in 2002 reported that STIs were on the rise among adolescents who had OTC access to emergency contraception and other forms of contraception.

Most of the above concerns have no or minimum scientific backing. Further supporting the reams of data that already establish Plan B as safe, a new study published in the journal of Obstetrics and Gynecology suggests that the pill is safe for adolescents and younger women. The analysis, which draws on information derived from an earlier randomized controlled trial, reports the experiences of 2,117 young women given access to Plan B, either directly (they were given three packets of Plan B in advance), through a pharmacy (where they could get Plan B for free and without a prescription) or at a clinic (where they had to see a doctor to get the drug).

"We didn't find, with regard to health issues, that younger women were any different than older women," said study co-author Philip Darney, chief of obstetrics and gynecology at San Francisco General Hospital and a professor at the University of California, San Francisco. The study also found that sexual behavior was not riskier among those who had pharmacy or direct access to the drug than among those who saw a doctor to obtain it.

Circumventing this delay on Plan B’s approval, seven states have already allowed the Plan B pill to be purchased without a prescription by asking the pharmacist. The states include California, Alaska, Hawaii, Maine, New Hampshire, New Mexico and Washington. Even Barr Pharmaceutical’s CEO acknowledged that in view of this perpetual limbo, the company might lobby individual states to make the product more accessible.

In a joint statement, 12 democratic senators and one independent said," The FDA’s decision leaves the strong impression that concerns about politics have overridden concerns about public health." Such kind of publicity is not doing FDA’s image any good, especially coming right after the Vioxx debacle where the agency was accused of ignoring scientific warnings about cardiovascular side-effects.

FDA’s action on Plan B reek of considerations outside the scientific and legal domain the agency is mandated to restrict itself to. Its silence, especially in the after-math of strong opposition and outcry to its latest actions suggests that strong political influences are at play. If this is the case, and we certainly hope that it isn’t, our faith in an agency long regarded as a protector of public health, based solely on strong scientific foundations, would be severely damaged. We hope that even if this Plan B case has succumbed to political considerations, it is a one-of-a-king case and that future FDA actions would be based entirely on scientific and legal merits.

The real direction of the FDA can be seen in future decisions and we hope that the FDA takes the high road and sticks to science and not politics. If they decide to continue to go down this road of politics over science then the country’s innovative prominence will surely be a thing of the past.

Update Sept 19, 05

FDA Guidance on Inspection of Manufacturing Facilities by Accredited Third Parties

The FDA on September 15, 2005 issued a guidance that provides information and lays down the criteria for requesting inspection of manufacturing facilities by accredited persons under the Inspection by Accredited Persons Program of the Medical Device User Fee and Modernization Act (MDUFMA) of 2002.

Section 201 of MDUFMA, as amended by the Medical Devices Technical Corrections Act of 2004(MDTCA), authorized FDA to establish a voluntary third-party inspection program applicable to manufacturers of Class II and Class III medical devices who meet certain eligibility criteria. Under this Inspection by Accredited Persons Program (AP Program), such manufacturers may elect to have third parties that have been accredited by the FDA conduct some of their inspections instead of the FDA.

The AP program applies to manufacturers who:

• Currently market their medical devices (Class II or Class III) in the United States AND
• Who market or plan to market their devices in one or more foreign countries and one or both of the following conditions are met:
  • One of the foreign countries certifies, accredits, or otherwise recognizes the AP the firm has selected as a person authorized to conduct inspections of device establishments OR
  • The firm submits a statement that the law of the foreign country recognizes an inspection by the FDA or by the AP
• In their most recent FDA or AP inspection were classified by the FDA as either Voluntary Action Indicated (VAI) or No Action Indicated (NAI)
• Submit a notice to the FDA requesting clearance (approval) to use an AP, identifying the AP intended to be used. The FDA should agree with this selection of an AP.

Medical Device User Fee Rates for FY 2006