Blog Tag: 510(k)
The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special” approach to the typical 510(K) process for medical devices.
The FDA describes the usual 510(K) process as “a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device…that is not subject to premarket approval.” According to the FDA, “Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) .”
Now, two recent guidance documents issued by the FDA allow for altered 510(K) approaches for certain medical devices. The first guidance, issued September 13, 2019, is for a “Special 510(K) Program.” The FDA describes this program as “an optional pathway for certain well-defined device modifications where a manufacturer modifies its own legally marketed device, and design control procedures produce reliable results that can form, in addition to other 510(k) content requirements, the basis for substantial equivalence (SE).” The guidance is intended to clarify “the types of technological changes appropriate for review as Special 510(k)s.” The new guidance also supersedes prior FDA guidance from 1998 regarding Special 510(k) policy in “The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.”
This MDDI article purports to offer a “handy checklist” to determine “if changes made to your medical device can be reviewed under the [Special 510(K)] program.” Some of the questions listed on the article’s checklist include the following:
- Is it a change to the manufacturer’s own device?
- Are performance data needed to evaluate the change?
- Is there a well-established method to evaluate the change?
- Can the data be reviewed in a summary or risk analysis format?
The second FDA guidance, also issued September 13, 2019, is for the “Abbreviated 510(K) Program.” The FDA describes the program as “an optional approach that may be used to demonstrate substantial equivalence in premarket notifications (510(k)s)” and that “uses guidance documents, special controls, and/or voluntary consensus standards to facilitate FDA’s premarket review of 510(k) submissions.” The guidance is “intended to facilitate 510(k) submission preparation by manufacturers and review by FDA.”
A copy of the guidance for the Special 510(K) Program can be found here, and a copy of the guidance for the Abbreviated 510(K) Program can be found here. The FDA currently states that comments on either guidance may be submitted at any time. Public comments on the guidance for the Special 510(K) Program may be submitted here and for the Abbreviated 510(K) Program here.
Recently, the U.S. Food & Drug Administration (FDA) announced plans to modernize FDA’s 510(k) clearance pathway, which was adopted more than 40 years ago. The FDA stated that the plans are aimed at continuing to ensure that new and existing devices meet their standard for safety and effectiveness as technology rapidly advances.
The FDA announcement reflects its focus on innovation by driving innovators toward reliance on more modern predicate devices. Under the current framework, medical device manufacturers are required to submit a premarket notification to demonstrate that the low- to moderate-risk device to be marketed is safe and effective by proving substantial equivalence to a legally marketed device (“predicate device”) that is not subject to Premarket Approval. According to the announcement, nearly 20 percent of current 510(k)s are cleared based on a predicate that’s more than 10 years old, contrary to the Agency’s belief that newer devices should be compared to the benefits and risks of more modern technology.
The Agency announced that it is considering, in the next few months, publishing on CDRH’s website those devices that have been cleared on the basis of demonstrated substantial equivalence of predicate devices that are more than 10 years old. The Agency also said that they are developing proposals to potentially subset certain older predicates and promote the use of more modern predicates. Following up on the announcement, FDA Commissioner Scott Gottlieb, M.D., stated,
As devices become increasingly complex, it’s important that they meet the latest standards for cybersecurity, interoperability, biocompatibility and usability engineering. The FDA has recently advanced policies on these issues, and we know that older predicates often don’t meet our more recent expectations.
Even though the announcement lacks details on these proposals, according to the announcement, in early 2019, the FDA intends to finalize guidance establishing an alternative 510(k) pathway that allows manufacturers of certain well understood device types to rely on objective safety and performance criteria to demonstrate substantial equivalence as a way to make it more efficient to adopt modern criteria as the basis for the predicates that are used to support new products.
The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary alternative pathway for new, moderate-risk devices for use in patient care.
According to Commissioner Gottlieb, the FDA regulatory processes for medical devices have remained relatively unchanged for over 40 years. Under a commonly used clearance pathway, device manufacturers are required to submit a Premarket Notification, known as a 510(k). The 510(k) constitutes a premarketing submission demonstrating substantial equivalence of a new device to a similar, legally marketed “predicate” device. The FDA explains that the submission allows the FDA to determine whether the device is as safe and effective as an equivalent device already placed into one of the three FDA classification categories.
However, Commissioner Gottlieb believes that “there are an increasing number of cases where this basic framework isn’t well-suited to reflect the innovation that we see today in certain technologies, and how we must evaluate those technologies.” Similarly, he states that the current 510(k) requirements fail “to realize the full potential of the FDA’s consensus standards program, which was established through the Food and Drug Administration Modernization Act of 1997, and will be refined and expanded as a result of provisions in the 21st Century Cures Act of 2016.” To address these shortcomings, the FDA plans to offer an alternative pathway for demonstrating substantial equivalence in a 510(k) submission.
Under the new pathway, Commissioner Gottlieb states that manufacturers could obtain clearance without direct comparison testing to a predicate device. Instead, substantial equivalence could be established by meeting objective safety and performance criteria, including FDA-recognized standards, FDA-developed guidance documents, or a combination of the two. The pathway would only be available for pre-specified categories of mature devices – those for which safety and performance criteria that meet or exceed the performance of existing, legally marketed devices can be identified.
Commissioner Gottlieb believes that this alternative pathway:
[H]olds tremendous promise to further streamline device review for sponsors and FDA and allow new innovations to get to patients more quickly; to allow more advanced technologies to be efficiently incorporated into new devices; and to foster greater confidence in the FDA’s ability to efficiently evaluate safety and benefits of technologies cleared under this pathway – all while maintaining the same gold standard that we apply to existing review processes.
The FDA will release its draft guidance on the new 510(K) pathway in the first quarter of 2018.
According to Medtronic news release, the company recently received 510(k) clearance from the U.S. FDA and a CE mark from the E.U. for its StealthStation™ ENT surgical navigation system. The system will assist surgeons performing procedures within the ear, nose, and throat (ENT) anatomy.
Medtronic explains that the StealthStation™ ENT works by generating an electromagnetic field within the ENT anatomy during surgery and allows surgeons to track the locations of instruments during procedures, much like a GPS system used for cars. The surgeons can view 3-D structures on a 27-inch, high-resolution touch-screen monitor. Medtronic already markets a similar system, the StealthStation™ S8, for use in neurosurgery and spine procedures.
The press release reports that StealthStation™ ENT system provides surgeons with enhanced visualization during procedures and also includes several software and hardware innovations such as Virtual Endoscopy. Virtual Endoscopy gives surgeons a simulated view of a patient’s sinus cavities that have previously been unavailable using traditional endoscopy. Thus, Medtronic explains, a surgeon can load a Virtual Endoscopy with a patient’s pre-operative data and practice that patient’s surgery prior to setting foot in the operating room.
The StealthStation™ ENT system should enhance patient outcomes and provide a valuable tool to surgeons. Dr. Joseph Raviv, director of endoscopic sinus and skull base surgery at NorthShore University HealthSystem commented:
The intraoperative use of computer-aided surgery is very helpful to assist the surgeon in clarifying complex anatomy during sinus and skull base surgery . . . . It provides an added level of assurance and may allow for a more thorough sinus procedure.
According to the press release, the Speedboat RS2 device and the associated CROMA energy platform received premarket clearance through the 510(k) process by demonstrating that the device is substantially equivalent to an existing legally marketed device. According to Creo, the FDA clearance was received earlier than expected. Expected to take roughly six months, the 510(k) process was completed just 49 days after submission.
The Speedboat RS2 device for endoscopic submucosal dissection is said to be the first of several devices planned for use with Creo’s CROMA radiofrequency and microwave generator. According to the announcement, the Speedboat RS2 is intended for removal of early stage cancerous and pre-cancerous lesions, and combines bipolar radiofrequency cutting and microwave coagulation for precise dissection and controlled hemostasis. The combined functionality is said to reduce the risk of puncturing tissue and enhances the safety profile of endoscopic lesion removal. According to Creo’s CEO Craig Gulliford,
Over the coming weeks, we will be looking to bring forward the development of our US capabilities whilst continuing with the promising training programme underway in Europe.
Globus Medical announced early today that the Excelsius GPSTM surgical platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as reported by a press release dated August 17, 2017.
Globus Medical, which describes itself as a musculoskeletal implant manufacturer, acquired the robotics developer Excelsius Surgical and its robotic guidance device Excelsius GPSTM three years ago according to press releases. The Excelsius GPSTM platform is said to function as a robot-assisted surgery guidance system “designed to minimize radiation exposure, streamline workflow, and reproducibly assist in implant placement,” according to the press release. Globus Medical further describes the platform as being compatible for use with pre-operative CT, intra-operative CT, and fluoroscopic imaging modalities.
The FDA’s decision is stated to allow the platform for use within minimally invasive and open orthopedic and neurosurgical procedures, including screw placement applications in spine and orthopedic surgery. This announcement also follows Globus Medical’s earlier news release announcing that the Excelsius GBSTM system received CE mark approval in the European Union.
Norbert Johnson, Vice President of Robotics, Imaging, & Navigation at Globus Medical, views these results as an example of Globus Medical’s developmental capabilities:
We believe the Excelsius GPS™ System will advance patient care and provide tangible benefits for surgeons and hospitals in terms of time, accuracy and reduced radiation exposure through the application of robotic and navigation technology in spine and orthopedic surgery.
The Excelsius GPSTM received FDA 510(k) clearance after Globus Medical re-filed its 510(k) bid following an FDA decision that Globus Medical’s initial bid had not “sufficiently addressed the FDA’s questions,” according to Mass Device.
The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k). The Notice indicates that anyone with pending 510(k) submissions for devices that are now exempt “should withdraw their submissions.”
According to the Notice, the exemptions from the 510(k) requirements do not apply to other statutory or regulatory requirements. Further, the Notice indicates there are limitations on some of the exemptions. Table 1 in the Notice lists exempt devices that are subject to general limitations of certain sections of the Code of Federal Regulations (CFR). Table 2 lists exempt devices subject to those general limitations and that must comply with partial exemption limitations as indicated in the table. Table 3 lists exempt devices classified as “radioallergosorbent (RAST) immunological test systems” but which are only a subset of all devices in that classification.
The FDA claims the exemptions “will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.” Further, the Notice states, “regulated industry will no longer have to invest time and resources in premarket notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review.”
The Notice was published in accordance with procedures established by the 21st Century Cures Act, which was signed into law December 13, 2016. According to the Notice, the 21st Century Cures Act requires the FDA to publish a list of each type of exempt class II device within 90 days after enactment of the Act and at least once every 5 years thereafter. The Notice reflects the FDA’s final determination regarding a proposed list of devices for exemption issued earlier this year. The relevant codified language for each listed device will be amended by the FDA in a “future action.”
The Food and Drug Administration (FDA) recently identified a list of Class II Medical Devices that, when finalized, will be exempt from premarket notification (510(k)) requirements. This publication was made by the FDA pursuant to the 21st Century Cures Act, signed into law on December 13, 2016.
Premarket notification (510(k)) is one of several alternative procedures that medical device manufacturers must undergo before being able to market their medical devices intended for human use. The 510(k) notification is required for medical devices that do not need to receive premarket approval (PMA) from the FDA and are not exempt from the 510(k) requirement. The FDA explains that medical devices are classified into three classes (Classes I, II, and III) based on based on the level of control necessary to assure the safety and effectiveness of the device. Most Class I and II devices and a few Class III are subject to the 510(k) requirement. Although a 510(k) applicant does not need to provide scientific evidence of safety and effectiveness for the intended use of its device, the applicant must demonstrate that the device is at least as safe and effective (“substantially equivalent”) to a legally marketed device (“predicate device”).
The FDA may exempt devices from 510(k) requirement. A list of factors that the FDA use to determine whether the device is exempt from 510(k) requirements includes: (1) whether the device does not have a significant history of false or misleading claims or of risks associated with inherent characteristics of the device; (2) whether characteristics of the device necessary for its safe and effective performance are well established; (3) whether changes in the device that could affect safety and effectiveness will either (a) be readily detectable by users by visual examination or other means before causing harm or (b) not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment; and (4) any changes to the device would not likely to result in the device’s classification.
Section 3054 of the 21st Century Cures Act amended sections 510(l) and 510(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The amended sections 510(l) and 510(m) of the FD&C Act require the FDA to publish any Class I and Class II devices that the FDA determines no longer require premarket notifications under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. The FDA is required to publish initial lists for Class II devices and Class I devices within 90 days and 120 days, respectively, after the enactment of the 21st Century Cures Act and then to update the lists at least once every 5 years.
A list of 510(k)-exempt Class I devices is expected to be published in about 30 days.
Voxello recently announced FDA 510(k) clearance of its noddle™ device, following submission of its application in October 2016. According to the press release, the noddle gives patients who are unable to speak a way to communicate through voluntary gestures. Voxello touts the noddle as allowing patient access to nurse call systems, environmental controls, communication apps, and speech generating devices with a touch or a click of the tongue.
Coralville, Iowa-based Voxello was founded in 2013 through the Iowa Medical Innovations Group (IMIG) at the University of Iowa. IMIG is an interdisciplinary program that includes students from the Colleges of Medicine, Business, Law, and Engineering. The noddle student team consisted of Vince Hahn, Zihan Zhu, Blake Martinson, and Ben Berkowitz, with Richard Hurtig serving as professor mentor.
At Voxello, our mission is to provide an effective and universal means to overcome communication barriers faced by hospitalized and long-term care patients. Today 3.9 million hospitalized patients each year are unable to communicate through traditional means, which results in an estimated three billion dollars in preventable adverse events. The FDA clearance of the noddle brings us one step closer to offering a solution for this urgent, unmet need.
The following video is provided on Voxello’s website:
Matthew A. Howard, Chair and DEO, Dept. of Neurology, University of Iowa Healthcare System, commented on his experience with the device:
The technology incorporated in the Voxello noddle has been extremely helpful in enabling us to provide the best possible care for neurosurgery patients with severe neurological injuries.
The U.S. Food & Drug Administration (FDA) issued a proposed guidance on August 8, 2016, regarding software changes to medical devices. The proposed guidance relates to requirements for submitting medical device software changes to the FDA for approval. The final document will provide assistance to medical device companies and the FDA for determining when changes to software or firmware for a medical device require FDA clearance. The medical devices covered include 510(k)-cleared devices and preamendments devices subject to 510(k).
The FDA’s proposed guidance explains that premarket notifications are generally submitted for commercially-distributed medical devices undergoing significant changes in design. Such changes include modifications that “could significantly affect the safety or effectiveness of the device” or a “major change or modification in the intended use of the device.” The proposed guidance relates to software changes and is an update to the original guidance issued in 1997 regarding changes to existing devices.
The “software” subject to the proposed guidance is defined as “electronic instructions used to control the actions or output of a medical device, to provide input to or output from a medical device, or to provide the actions of a medical device.” This includes software embedded in a device, software that is an accessory to another device, and “software that is intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device.”
The FDA provides a flow chart for assisting with the determination, see below. Issues addressed in the determination include changes related to: strengthening cyber security; meeting specifications of the most recently cleared device; introducing or affecting hazardous situations; creating new risk control measures; and affecting clinical functionality or intended use of the device. Additional factors to consider beyond those in the flow chart and some examples of modifications are provided in the draft guidance as well.
The proposed guidance notes that in some cases a new 510(k) is not necessary, and that existing Quality System (QS) requirements may suffice. Such QS requirements mandate, among other things, that the manufacturer maintains records, for production upon request, regarding such changes and the processes used to determine the changed device meet the design specifications. Further, the proposed guidance does not apply to software for which the FDA has previously said it will not enforce compliance, including some mobile apps used with medical devices.
Some observers think the proposed guidance will help with improving cybersecurity of connected medical devices. The public may provide comments to the FDA on the proposed guidance until November 7, 2016: comments may be submitted electronically here.
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the PROLIFT Expandable Interbody System of Life Spine. Accordoing to its website, Life Spine is a medical device company based in Huntley, Ill., that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders.
According to press releases, the PROLIFT system is the latest addition to the company’s platform of expandable interbody technologies. According to Life Spine, PROLIFT is an all-titanium system restores disc height, in-situ, for minimally invasive Posterior Lumbar Interbody Fusion (PLIF), Transforaminal Lumbar Interbody Fusion (TLIF) and oblique approaches. Once implanted, the system can expand cephalad to caudal to accommodate disc height ranges from 8mm to 16mm for varying patient anatomy.
According to Life Spine, “When paired with the CENTERLINE™ Midline Thoracolumbar Screw System, PROLIFT creates the optimal hyper-minimally invasive solution.” “The PROLIFT Expandable Interbody System allows for simplified, contracted insertion with minimal anatomical disruption and retraction,” said Rich Mueller, Chief Operating Officer of Life Spine.
Life Spine plans to launch a limited release of the PROLIFT system in the second quarter of 2016, and full product release is expected later in the year.
According to the Indications for Use Statement and the 510(k) Summary, Vera is a software system that uses the Microsoft Kinect technology to support physical rehabilitation of adults in the clinic and at home. The 510(k) submission states that the Microsoft Kinect Sensor uses structured infrared light to determine the position of objects in its field of view in three dimensions including distance, or “depth,” from the sensor.
Reflexion’s FDA submission also notes that the Vera software provides medical professionals the tools to record video and track movements in 3D space in order to identify motion and count repetitions during patient participation with a prescribed exercise. Data derived from motion tracking as well as the recorded video can be reviewed by medical professionals to assess exercise movements and adherence to the prescribed exercise.
The 510(k) submission further states that, more specifically, the Vera system includes rehabilitation exercises for legs with audio-visual feedback and graphic movement representations for patients, as well as remotely accessible patient performance videos. Patient assessment, exercise guidance, and approval by a medical professional are required prior to use.
According to the Company’s website, Reflexion is currently partnering with the Cleveland Clinic and the Brooks Rehabilitation Center in Jacksonville, Florida to deliver Vera to patients recovering from joint replacement surgeries. A press release from the Brooks Rehabilitation Center regarding the partnership can be found here. A demonstrative picture from the press release is shown above. According to another press release, Reflexion has also received a $1 million grant from the Centers for Disease Control and Prevention to use Vera in fall prevention for seniors. As part of this grant, the technology is currently employed in two senior populations in San Diego, California and Fearrington, North Carolina. A video of the Vera software can be accessed below.
Allergan recently announced that it has completed its acquisition of AqueSys. AqueSys is a privately held company, headquartered in Orange County, California, focusing on “commercializing implantable devices that will significantly improve the treatment of glaucoma, . . . the world’s leading cause of irreversible blindness.”
According to the press release, Allergan’s acquisition of AqueSys is an all-cash transaction that includes a $300 million up front payment with potential milestone payments contingent on the development of XEN45, AqueSys’ leading product. Allergan states that the acquisition of “XEN45 adds to Allergan’s strong late-stage eye care pipeline, with therapies in development to treat glaucoma, dry eye disease, age-related macular degeneration (AMD) and diabetic macular edema (DME).” Allergan reports that final FDA 510(k) clearance of the XEN45 is expected in late 2016 or early 2017.
The acquisition of AqueSys and XEN45 is highly complementary to our leadership position in eye care and underscores our commitment to develop and commercialize treatments that advance care and add value for ophthalmologists and their patients. The treatment of glaucoma is increasingly shifting to dropless therapies given the challenges of patient compliance. The XEN45 device provides a minimally invasive approach to lowering IOP [intraocular pressure] for physicians and their patients seeking new ways to treat glaucoma that go beyond conventional eye drop treatments.
According to its website, Allergan is a multi-billion dollar global pharmaceutical company, which focuses on six therapeutic areas: dermatology and aesthetics; CNS; eye care; women’s health and urology; GI and cystic fibrosis; and cardiovascular and infectious disease. Allergan’s global headquarters are in Dublin, Ireland while its U.S. headquarters are in Parsippany, New Jersey.
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.
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.
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.
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 Regulations.gov, or mailed to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.