Blog Tag: FDA

Bills Introduced to Streamline FDA Review of Medical Devices

U.S. Senators Cory Gardner (R-CO) and Joe Donnelly (D-IN) recently introduced the Rare Device Innovation Act and the FDA Regulatory Efficiency Act.  The bills, if passed, would streamline the U.S. Food and Drug Administration (FDA) approval process for a number of medical devices.  A press release from Senator Gardner states that “this legislation allows the FDA to spend more time reviewing new breakthrough technologies and expedite them to the market for patients who need them.”

According to the press release, the Rare Device Innovation Act makes it easier for medical devices to qualify for expedited approval.  In order to qualify for the expedited approval process under the current Humanitarian Use Device (HUD) program, medical devices must treat diseases that exist in fewer than 4,000 patient cases, annually, in the U.S.  The Rare Device Innovation Act proposes to increase that number to 8,000, which according to the press release will “create[] an incentive for manufacturers to develop medical devices for rare diseases to help people with rare conditions gain access to technologies they would not otherwise.”  Devices covering diseases like ALS, cerebral palsy, Hodgkin’s lymphoma, mesothelioma, and tuberculosis would qualify under the bill, according to Senator Gardner’s press release.

As outlined in the release (and as a major departure from present FDA practice), the FDA Regulatory Efficiency Act seeks to allow accredited third-parties to perform initial reviews of 510(k) medical devices. Medical devices that qualify under 510(k) are low-risk medical devices that are substantially similar to those already approved by the FDA. Examples of qualifying devices include powered wheelchairs, shunts, and CT scanners.

Regarding the proposed FDA Regulatory Efficienty Act, Senator Donnelly’s press release states: “The legislation would still hold companies accountable for their quality systems, while also helping to alleviate the overwhelmed FDA.”

The proposed third-party 510(k) review appears to have some degree of industry support.  In fact, AdvaMed (the “Advanced Medical Technology Association”) recently commended Senators Donnelly and Gardner on introduction of the FDA Regulatory Efficiency Act.   JC Scott, senior executive vice president, government affairs, for the Advanced Medical Technology Association stated:

This legislation would create a voluntary program under which medical technology companies could have their quality system certified by an FDA-authorized third party.  This certification would allow companies to self-certify certain low-risk changes to currently marketed devices.  These changes would be limited to minor alterations to an existing product or manufacturing process currently covered by 30-day notices for PMAs [pre-market approval applications] and ‘special 510(k)s’ for 510(k) products . . . .  This new program will helps ensure that companies are accountable for this minor changes while lessening the burden on FDA, allowing the agency to focus on higher-priority activities . . . .  We look forward to working with members of Congress, FDA and other key stakeholders to move this important legislation forward.

NuVasive Receives First-Ever 510(k) Clearance for a Cervical Corpectomy Cage

NuVasive Receives First-Ever 510(k) Clearance for a Cervical Corpectomy Cage

Spinal device specialist NuVasive recently received section 501(k) FDA clearance for its X-Core Mini Cervical Expandable VBR System, a titanium vertebral-body replacement device used in the cervical spine to replace vertebral bodies damaged by tumors, fractures, or osteomyelitis.

According to NuVasive’s FDA filing, the X-Core Mini system can also be used for reconstruction following a corpectomy or to restore the integrity of the spinal column without resorting to spinal fusion in patients that have short life expectancies due to advanced-stage tumors involving the cervical spine. The X-Core Mini system is available in a variety of sizes and shapes to accommodate differences in individual patients’ physical characteristics and pathology.

NuVasive states that the X-Core Mini must be used with supplemental fixation that has previously been cleared by the FDA for use in the cervical spine, which includes NuVasive’s new Archon Reconstruction Corpectomy plate. This plate is designed to increase rigidity and to resist screw pullout.

In a company news release NuVasive’s President and Chief Operating Officer, Pat Miles, stated:

The assembly of best-in-class cervical products into a cohesive procedural offering further reinforces NuVasive’s commitment to providing single-source, integrated procedural solutions to our customers. Combining X-Core Mini VBR and Archon Reconstruction plate provides another excellent example of defining the components necessary to properly address an unmet market need as NuVasive remains focused on becoming number one in spine.

According to Fierce Medical Devices, NuVasive became the third-largest competitor in the spinal device market last year. NuVasive maintains an active patent portfolio to help protect its market share: the USPTO Assignment Database lists NuVasive as the Assignee of 325 patents and patent applications dating from 1999 to the present.

FDA Establishes Patient Engagement Advisory Committee

The FDA recently announced establishment of the Patient Engagement Advisory Committee (PEAC).  According to a notice published by the FDA, the PEAC will advise the Commissioner of the FDA, presently Dr. Stephen Ostroff, M.D., “on complex issues relating to medical devices, regulation of devices, and their use by patients.”  In an FDA Voice blog post, Nina L. Hunter, Ph.D., and Robert M. Califf, M.D., stated:

[The PEAC] will give FDA the opportunity to obtain expertise on various patient-related topics, with the goal of improving communication of benefits and risks and increasing integration of patient perspectives into the regulatory process.

According to the FDA, PEAC will have 9 core voting members, including a committee chair, to be selected by the Commissioner.  The voting members, who will have expertise in patient needs in connection with medical care, clinical research,  and healthcare communication, will serve overlapping terms of up to 4 years.  The notice states that the Commissioner may also select a technically qualified voting consumer representative recommended by consumer oriented organizations.  Depending on the meeting topic, a pool of nonvoting industry representatives selected by the Commissioner and nominated by the medical device industry may also participate in PEAC meetings.

The FDA has established a public docket for comments on topics the PEAC could consider, which currently include: “[FDA] guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, available alternatives, patient reported outcomes and device-related quality of life or health status issues, and other patient-related topics.”  The public is invited to provide comments online, or by mail to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.  Comments must reference Docket No. FDA-2015-N-3166, and must be received by the FDA by November 20, 2015.

The FDA is also soliciting nominations for voting members, which must be received by November 20, 2015, the voting consumer representative, which must be received by October 21, 2015, and a pool of nonvoting industry representatives, which must be received by October 21, 2015.

Edwards Completes Acquisition of CardiAQ

According to PRNewswire, Edwards Lifesciences Corporation recently completed its acquisition of CardiAQ Valve Technologies, Inc, a developer of transcatheter mitral valve replacement systems, which follows from Edwards’ acquisition agreement announced last month.  The article reports that Edwards paid $350 million cash for CardiAQ at closing, with an additional $50 million to be paid upon reaching a European regulatory milestone.

Michael Mussallem, Edwards’ Chairman and CEO, stated:

We look forward to the CardiAQ team joining Edwards.  We believe the combined knowledge and efforts of the talented CardiAQ and [Edwards’ own] FORTIS transcatheter mitral valve system teams will help us advance a therapy that offers a meaningful solution for patients.

Marketwatch reports that none of CardiAQ’s valve systems are presently approved for sale in any country.  However, according to PRNewswire CardiAQ has received U.S. FDA Investigation Device Exemption approval to conduct an early feasibility study of up to 20 patients, and also plans to initiate a CE Mark study in Europe.

Zyga Receives 510(k) Clearance

Zyga Technology, Inc., a medical device company dedicated to the research, development, and commercialization of surgical solutions to treat conditions of the lumbar spine, recently announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market its SImmetry® Sacroiliac Joint Fusion System using either a two-incision or a single-incision technique. The SImmetry System uses a minimally invasive surgery procedure and is designed to stabilize the sacroiliac joint.

David Greenwald, M.D. of the Flagler Brain and Spine Institute in St. Augustine, stated:

In the operating room, surgeons need as many options as possible to effectively treat each individual. . . .  This new SImmetry technique allows me to offer patients a single, one-inch incision and to adapt the surgery to their individual anatomy and condition.

The Centers for Disease Control and Prevention lists low back pain as the second most common cause of disability of adults in the U.S.  Accordingly, the Centers for Medicare and Medicaid Services assigned a Category 1 CPT code to minimally invasive sacroiliac joint fusion, improving patient access to the procedure.

Expedited Access Program Begins For Medical Devices

Expedited Access Program Begins For Medical Devices

On April 15th, the U.S. Food and Drug Administration (FDA) began its Expedited Access Program (EAP), which is designed to get certain medical devices to market sooner. Under the EAP program, device sponsors collaborate early with Center for Devices and Radiological Health (CDRH) staff to put together a Data Development Plan with the agency.

Jeffrey Shuren, director of the CDRH, states that the EAP is a way “to speed qualifying devices to patients with life-threatening or irreversibly debilitating conditions without compromising FDA’s high standards for safety and effectiveness.” Shuren goes on to say that “Under the EAP, FDA may accept a greater degree of uncertainty if it is sufficiently balanced by other factors, including the probable benefits to having earlier access to the device.”

To participate in EAP, a device sponsor must submit to the FDA a request for EAP designation. Factors the FDA considers when making benefit-risk determinations for devices subject to premarket approval applications (PMA) are discussed here.

To receive EAP designation, a device must meet three criteria:

(1) the device is intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition;

(2) the device meets at least one of the following criteria: (i) no appropriate alternative treatment or means of diagnosis exists, (ii) the device represents a breakthrough technology that provides a clinically meaningful advantage over existing legally marketed technology, (iii) the device offers significant, clinically meaningful advantages over existing legally marketed alternatives, or (iv) the availability of the device is in the best interest of patients; and

(3) the sponsor submits an acceptable draft Data Development Plan.

FDA Issues Draft Guidance Document on Acceptance of Foreign Medical Device Clinical Data

The FDA recently issued a draft guidance document regarding its policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices.  In view of the “increasingly global” nature of clinical research, the FDA issued the guidelines to clarify the standards under which foreign clinical data will be accepted.

Under the FDA’s existing framework, and in particular for Premarket Approvals (PMA), the FDA will accept foreign clinical data if it conforms with the 1983 version of the Declaration of Helsinki, or the local rules of the country in which the clinical study was conducted.  If using the local rules, the sponsor must detail any differences between the local rules and the Declaration, and explain why the local rules are more protective of human test subjects.  One of the proposed rules would require that foreign clinical studies used to support PMAs, Investigational Device Exemptions (IDEs), Humanitarian Device Exemptions (HDEs), and 510(k)s be conducted according to good clinical practice (GCP).

The FDA also states that, for many device premarket applications, like 510(k)s, PMAs, and de novos, foreign clinical data “can be used to support clearance or approval of the application” as long as the data constitutes valid scientific evidence under 21 CFR 860.7.  The FDA encourages sponsors to submit the foreign clinical studies for review through the FDA’s Pre-Submission process, before using the studies to support an application.

The draft guidance document further lists three special considerations that may be applied to foreign clinical studies to ensure that they satisfy FDA standards, namely (1) differences in clinical conditions, (2) differences in study populations, and (3) differences in regulatory requirements.  These special considerations are intended to identify whether the results of a foreign clinical study can be generalized to apply to US clinical practices, the US population, and FDA  requirements, respectively.  To illustrate application of these special considerations, the FDA has provided 7 examples and explains the outcome of applying the special considerations to the examples.

According to the Federal Register, public comments on the draft guidance document must be submitted to the FDA by July 20, 2015. Comments may be submitted online to, or mailed to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FDA Approves Expanded Use of Medtronic’s CoreValve System; Also Receives Regulatory Approval in Japan

This week the U.S. Food and Drug Administration announced its approval of Medtronic’s CoreValve system for “valve-in-valve” (VIV) replacement. According to the FDA press release, this represents the first transcatheter aortic valve replacement device approved for use in replacing a previously implanted artificial valve. The press release explained the need for replacing artificial valves over time:

Some patients whose own aortic valve failed to work properly in the past undergo open-heart surgery to replace the faulty valve with an artificial heart valve. Over time, artificial valves that are made of animal tissue wear out—becoming narrowed, leaky or both—and may need to be replaced again.

The press release notes that prior to this approval, the only option for patients needing to replace an artificial aortic valve was open heart surgery; however, some such patients may not be qualified candidates for open heart surgery.  The press release also stated that the CoreValve system can now provide a less invasive alternative for replacing artificial valves, thereby opening the option of subsequent valve replacements to a new category of patients. Medtronic provided data on the CoreValve Expanded Use Study Failed Bioprosthetic Surgical Valve on its website.

According to press releases, the CoreValve system also just received regulatory approval in Japan, in addition to previous regulatory approval in the U.S. and Europe.


FDA Issues New Rules for Testing of Reusable Medical Devices

The U.S. Food and Drug Administration (FDA) recently announced its tougher new requirements for testing reusable medical devices.  According to the FDA’s News Release, the new rules are “aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection.”  The guidance document (Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling) also includes recommendations medical device manufacturers should follow pre-market and post-market for the safe and effective use of reprocessed devices.

The new rules and recommendations are based on draft proposals that the FDA released in 2011 for public comment.  The rules’ issuance follows the news of the deaths of two patients from “superbug” infections that have been linked to reusable medical scopes. Olympus, the manufacturer of the implicated scopes, is being sued for failing to issue updated cleaning instructions after a recent redesign, and for selling a “defective scope,” among other allegations.

The FDA’s new rules will only apply to new devices receiving FDA approval, not to devices that are currently on the market.  The New York Times reported that “Officials acknowledged that they could only recommend — not require — that products on the market use the more rigorous testing.”

The FDA has said that that the new rules incorporate new testing requirements intended to make reprocessing reusable medical devices more effective.  For example, manufacturers will be required to submit data to show that their reusable medical devices, such as duodenoscopes, endoscopes, and bronchoscopes, can be properly disinfected.  Manufacturers had previously been required to collect this data, but were not required to submit it to the FDA.

According to the FDA’s press release, the guidance document further “recommends that manufacturers consider reprocessing challenges early in device design.”

Olympus Sued Over “Superbug” Infections

The New York Times recently reported that 179 patients at the UCLA Ronald Reagan Medical Center were exposed to a potentially deadly “superbug” between October of 2014 and January of 2015.  As of February 18, the infection of seven patients was confirmed.  UCLA issued a press release in which it stated that the infection was a “contributing factor” in the death of two of those patients.

National news, including the NYT, Washington Post, and Chicago Tribune, rapidly mobilized to report on the deadly “superbug” — “Carbapenem-Resistant Enterobacteriaceae” (CRE).  The CDC states that “some CRE bacteria have become resistant to most available antibiotics. Infections with these germs are very difficult to treat, and can be deadly—one report cites they can contribute to death in up to 50% of patients who become infected.”

It quickly became apparent that the infections were due to the use of infected (reusable) duodenoscopes manufactured by Olympus for use in endoscopic retrograde cholangiopancreatography.  According to the the LA Times and Chicago Tribune, while such scopes are used in about 500,000 patients annually, they are increasingly being linked to an ever-rising death-count (including, for example, an outbreak 6 years ago in Florida that killed 15).

The LA Times reports that the FDA has been aware for more than two years that the design of Olympus’ scope may be so flawed that “it cannot be properly cleaned.”  CNN reports, however, that the problem may have been known for much longer.  CNN quoted the president of the American Gastroenterological Association, Dr. John Allen, as claiming that “[t]his problem has been known since at least 1987.”  In response, the FDA has stated that, for most patients, the benefits of the procedure using the duodenoscope “far outweigh the risks of possible infection.”

The recent CRE outbreak has sparked a lively debate over the liability of the device manufacturers for such allegedly flawed designs.  That debate has recently found a new forum as two suits have been filed against Olympus in California State Court.

The first suit, the LA Times reports, was filed by 18-year-old Aaron Young who was exposed to infected scopes in October and January.  Reuters reports that Mr. Young alleges negligence and fraud because the cleaning protocols for the complex device were not updated following a recent redesign.  Bloomberg reports that the complaint names Olympus and three members of its endoscopy team as defendants.

The LA Times reports that the second suit was filed by the family of now-deceased 48-year-old Antonia Torres Cerda and alleges wrongful death as well as products liability, negligence, and fraud in selling and promoting a “defective scope.”   The complaint names Olympus and several members of its Endoscopy sales group as defendants.

Peter Kaufman, of Panish Shea & Boyle, the attorney representing both Young and Cerda’s family, has been quoted as saying that he expects to file four to six more cases in the next week, three of which will be wrongful death suits.

FDA Approves EnteroMedics’ Implantable Obesity Treatment Device

St. Paul, MN-based EnteroMedics Inc. recently announced  that the Food and Drug Administration (FDA) approved the use of its VBLOC vagal blocking therapy, delivered via its Maestro system.  The system is indicated for treatment of obese adults having a Body Mass Index (BMI) of at least 40 to 45 (units of Kilogram per Meter squared), or a BMI of at least 35 to 39.9 with a related health condition such as high blood pressure or high cholesterol levels, and who have already tried to lose weight in a supervised weight management program within the past five years. A news release by the FDA further noted that the Maestro System is the first obesity treatment device to be approved by the FDA since 2007.

According to the Wall Street Journal, the Maestro system disrupts signals between the stomach and brain by blocking electrical signals in the abdominal vagus nerve through the use of high-frequency electrical pulses. The FDA reported that the Maestro System was evaluated in a 233-patient clinical study where the experimental group lost about 8.5% more of its excess weight than the control group in a 12 month period.  The FDA further reported that about half (52.5%) of patients in the experimental group lost at least 20% of their excess weight, and 38.3% of the experimental group lost at least 25%. According to NBCnews,  as part of the approval process, EnteroMedics must conduct a five year post approval study following at least 100 patients to collect additional safety and effectiveness data.

According to its website:

EnteroMedics® is committed to the delivery of safe, effective and sustainable therapies that address the growing global health crises associated with the increased prevalence of obesity and metabolic diseases, including diabetes and hypertension. EnteroMedics is rapidly advancing its novel technology, VBLOC® vagal blocking therapy delivered via the Maestro® Rechargeable System, to broadly benefit patients, health care providers and stakeholders around the world.

FDA Approves Ebola Treatment Protocol Using Aethlon Hemopurifier®

San Diego-based Aethlon Medical, Inc. recently announced that the United States Food and Drug Administration (FDA) has approved the use of its Aethlon Hemopurifier® bio-filtration device in a clinical protocol for Ebola treatment.  The approval allows for an investigational study at up to 10 U.S. locations with up to 20 U.S. subjects.

According to PRNewswire, Aethlon’s Ebola protocol was submitted to the FDA as a supplement to a previously approved Investigation Device Exemption (IDE) under which Aethlon is conducting a clinical feasibility study of Humopurifier® therapy in Hepatitis C patients who are also receiving chronic dialysis therapy.  Aethlon previously reported that the Hemopurifier® was used to treat a critically-ill Ebola patient at Frankfurt University Hospital in Germany.  According to Aethlon’s website, the device has also been used to reduce viral load in HIV patients, and in vitro studies have shown it captures exosomes underlying various types of cancer.  Fierce Medical Devices reports that a collaboration between Aethlon and the Sarcoma Oncology Center (SOC), which is based in Santa Monica, California, is studying the ex vivo effectiveness of the Hemopurifier® to remove exosomes from the blood of advanced-stage cancer patients.

FDA Science Chief Reports Quicker Medical Device Clinical Trial Approvals

In a speech in Cambridge on December 11, 2014 (which was reported on in an article in the Boston Business Journal), Dr. Bill Maisel– the science chief of the U.S. Food and Drug Administration’s center to oversee approval of medical devices – addressed long-standing complaints that the time to approve trials and new devices was too long.

According to the Boston Business Journal, Maisel spoke before members of MassMEDIC, Boston’s advocacy group for the medical device industry, and his speech was part of a daylong FDA Update event intended to give an overview on hot topics in regulatory approval in 2015.

The article reported that the FDA is on track to “meet or exceed” its own deadlines for approval and has worked in the past 2-3 years to cut half of its backlog of applications.  As for the coming year, Maisel was quoted as stating that his priority is “strengthening the clinical trial enterprise.”

The article also stated that the FDA has cut down the average length of time of the submission of an application to conduct a clinical trial to decision by 75% in the past three years (from an average of 400 days to 2011 to 101 days this year).

According to the article, Maisel also remarked that the FDA was taking other steps to expedite approvals including:

  • reviewing categories of devices considered high-risk to see if any of them can be downgraded; and
  • the possibility of an “Expedited Access PMA” program – an accelerated approval program for companies developing products designated as high risk but in areas with significant needs.

More information for the FDA’s Monthly PMA (Premarket Approval)/PDP (Product Development Protocol) Decisions and Summary Statistics can be found here.


FDA Posts Largest-Ever Medical Device Recall

FDA Posts Largest-Ever Medical Device Recall

On August 29, 2014, the FDA issued 233 Class I medical device recalls for products manufactured by Customed.  According to its website, Puerto Rico-based Customed is a  medical supplies leader and distributes a wide range of products to many hospitals and thousands of doctors’ offices, hospices, laboratories, radiology centers, pharmacies and other healthcare facilities.

According to the FDA’s website, Customed voluntarily recalled the 233 devices due to packaging flaws.  The devices recalled include various medical and surgical packs (e.g., laparotomy pack, femoral pack, labor & delivery pack, open heart tray pack, etc.), all having sterile packaging.  The device supplier stated in a recent press release that the sterile convenience surgical packs were found to have potential defects in packaging adhesion that could result in a loss of product sterility and subsequent patient infection.  The Regulatory Affairs Professionals Society (RAPS) estimates the number of affected units to be several hundred thousand.  As of August 21, 2014, no serious injuries or deaths were reported.

According to the FDA’s website, medical device recalls remove a product from the market and may be conducted on a company’s own initiative, by FDA request, or by FDA order under statutory authority (21 CFR § 810.1 et seq.).  To reflect varying severity of risk presented by different devices being recalled, FDA recalls are categorized as Class I, Class II, or Class III.  Those classes are defined as follows:

Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

RAPS reports that, aside from a few statistical outliers, the overwhelming majority of all FDA medical device recalls are either Class II or Class III recalls (reflecting “lesser (and non-deadly)” safety risks).  In fact, since 2004, Class I, Class II, and Class III recalls comprised 6%, 86%, and 7% of total recalls, respectively.  While the FDA typically recalls 13-75 devices daily, RAPS reports that there have historically been relatively few major device recalls despite an overall upswing in the number of recall events since 2012.

According to RAPS, the Customed device recall represents the single largest FDA recall to date, regardless of class, and is more than 9 times larger than the second largest Class I recall (which occurred on March 5, 2014).


FDA Releases Guidance on Medical Apps

There seems to be a mobile app for just about everything now.  Among the multitude of apps available are an increasing number of medical apps.  In response to this growing trend, the FDA has issued a final guidance document for developers of mobile medical apps.  The guidance explains that the FDA plans to limit its scrutiny to apps that transform a mobile device into a regulated medical device or are intended to be used as an accessory to a regulated medical device because these types of apps could be harmful if they don’t function properly.

The final document follows a draft issued in July 2011 that received more than 130 comments.  In response to comments seeking more clarity, the FDA included in the final version more examples of what the agency does and does not intend to regulate.  According to the guidance document, examples of apps that will be the subject of oversight include apps that calculate the amount of radiation to be given to a cancer patient and apps that control inflation and deflation of a blood pressure cuff.  The guidance indicates that these types of apps essentially perform the functions of traditional medical devices, and notes that the FDA will regulate them as it does traditional devices.

According to the guidance document, the agency plans to leave low-risk apps alone, even those that might fall under the definition of a medical device.  For example, apps that allow doctors or patients to log blood pressure readings or diet related apps that recommend the number of calories a person should consume may not be scrutinized.  The guidance document also clarifies that providers of medical apps, for example, the iTunes app store, will not be treated as medical device manufacturers.