After multiple clinical studies and extensive use in overseas markets, the DigniCap® scalp cooling system is the only such device to have completed an FDA-cleared multi-center clinical trial and is cleared for use with treatment regimens associated with breast cancer. More information about the device may be found here.

The FDA cleared the DigniCap through the de novo process. The de novo process, a relatively new pathway, provides an alternate means of clearing novel devices of low to moderate risk. Initially, Dignitana submitted the device for Premarket Approval (“PMA”) to the FDA at the beginning of 2015. After a brief review, the FDA converted the PMA to the de novo regulatory pathway since the FDA did not consider the DigniCap System a high-risk device warranting a PMA.

Through the De Novo process, device sponsors are able to utilize a hybrid-type pathway for clearance by bringing low-risk devices to market in situations where they would not otherwise be able to utilize the more confined 510(k) pathway. In particular, where the 510(k) pathway is most-frequently used to clear new devices, it is only available to those new devices that have a clear predicate device or are substantially equivalent to another legally marketed device. Devices that do not otherwise have a predicate device available but are still lower-risk that would be appropriate to merit a PMA, now have a pathway via the de novo process. More information about the De Novo process can be found here and here.

Navigating the FDA’s web of regulations governing medical devices can be a daunting task. If you have any questions about FDA regulations or how they relate to the marketing of a medical device, please contact us at contact@sglawfl.com.

The Court found that the FDA would have to utilize formal device reclassification procedures if the Agency wanted to make changes to the device’s status. Device reclassification, which is accomplished through the formal rulemaking process, removes a device from the market, requiring the device to go through the approval process before it can be marketed again. This process includes a notice and public comment period before the device reclassification is finalized and the device may be removed from the market. Accordingly, by finding that the FDA must actually reclassify a cleared device in order to have the authority to effectively change its previous determination, the Court found that the FDA had exceeded its authority in the present case. In addition, the Court struck down the FDA’s assertion that it had “inherent reconsideration authority” when reclassifying a device. The court’s holding reinforces the importance of the device reclassification procedures outlined in the Federal Food, Drug, and Cosmetic Act (“FFDCA”), which include notice and public comment through formal rulemaking.

The Federal Food, Drug, and Cosmetic Act mandates that the FDA classify medical devices into one (1) of three (3) categories, Class I, Class II, and Class III. Class I devices generally pose little to no risk and are subject to the least amount of regulatory controls. Class II devices are higher risk devices that require increased regulatory controls and typically must receive clearance prior to marketing. Class III devices are the highest risk devices and are subject to the strictest regulatory control; Class III devices must be approved by the FDA prior to being released to the market.

Generally, prior to marketing a Class II device, the device sponsor must utilize the Premarket Notification process, as prescribed in Section 510(k) of the FFDCA. For more information on Section 510(k) please visit our website. Failure to comply with Section 510(k) can result in serious consequences. For Class III devices, Premarket Approval, as distinguished from clearance, is required, unless it falls under the exemptions found in applicable FDA regulations.

With respect to device reclassification, the FDA must take very specific steps, as outlined in section 515 of the FFDCA, in order to properly reclassify a device. In particular, the FDA must do five (5) things before a device can be reclassified:

1. Collect existing scientific information from scientific experts in the medical community and assess the risks and benefits of the medical device type subject to the device reclassification;
2. Convene a meeting of the medical device advisory committee to request input on the device reclassification;
3. Issue a proposed order reclassifying the device type into Class I, II or III;
4. Review and consider comments submitted by the public, and
5. Issue a final order reclassifying the device type into Class I, II or III.

If you are marketing a medical device, compliance with the FDA regulations is important. If you have any questions about compliance with FDA regulations, please contact us at contact@sglawfl.com

In the letter, the FDA explains that urinanalysis dipsticks are cleared only when they are interpreted by a direct visual reading. Any company intending to market a device for automated reading of the dipsticks must obtain clearance for the reader and the test strips as used together. In this case, Biosense is required to either identify an FDA clearance for the medical mobile app or provide an explanation as to why it does not believe that additional 501(k) clearance is necessary. According to the terms of the Letter, the company must submit the requested information to the FDA within 30 business days.

The FDA currently regulates medical mobile apps on a case-by-case basis. In the agency’s Draft Guidance–Medical Mobile Applications, a medical mobile app is defined as a software application that meets the definition of a device pursuant to section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA) and is either used as an accessory to a regulated medical device or transforms a mobile platform into a regulated medical device. Specifically, a mobile app is a medical device when it is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or other condition or is intended to affect the structure or any function of the body.

In sum, the FDA requires medical device manufacturers and/or marketers, including those manufacturing and marketing mobile medical apps, to submit a premarket notification, also known as a 510(k), 90 days in prior to marketing unless the device is otherwise exempt from these requirements. More information about the pre-market notification process can be found here or at our previous post here. If you have any questions about obtaining a 510(k) clearance or the regulation of medical mobile applications, please contact us at contact@sglawfl.com.

An inflammation of the stomach and intestines, infectious gastroenteritis is caused by certain parasites, bacteria, or viruses and can be detected by common symptoms such as diarrhea, vomiting. The condition can be a serious affliction for infants, the elderly, and anyone suffering from a weakened immune system. Further, it can be spread quickly by contaminated water, food, and surfaces as well as person-to-person contact. As recently reported by the Centers for Disease Control and Prevention (CDC), there was a significant spike in gastroenteritis-associated deaths in the United States in the period from 1999 to 2007, with an increase from just under 7,000 to more than 17,000 deaths annually. Accounting for almost two-thirds of those deaths were Norovirus and Clostridium difficile.

The manufacturer of xTAG Gastroenteritis Pathogen Panel (GPP), Luminex, Inc., gained clearance for its multiplexed nucleic acid test through a clinical trial, wherein the Company demonstrated the device’s effectiveness in detecting the following causes of gastroenteritis:

Bacteria

• Campylobacter
• Clostridium difficile
• Shiga-like Toxin producing E. coli
• shigella
• salmonella
• Enterotoxigenic Escherichia coli
• Esrcherichia coli

Virus

• Norovirus
• Rotavirus A

Parasite

• Cryptosporidium
• Giardia

Because of the ability to test for gastroenteritis from a multitude of sources, tests of this kind will help doctors to quickly identify the source of the problem and provide for more effective and faster treatment.

xTAG GPP was cleared by the FDA through the de novo classification process, the regulatory pathway for medical devices that are seen as being of low to moderate risk but are not comparable to a device that is already on the market. As opposed to devices that receive clearance through the widely-used 510(k) process, the de novo process is appropriate for devices that are not substantially equivalent to devices already on the market. More information about the de novo process may be accessed here.

If you have additional questions with respect to how you can find out more about this revolutionary device or the FDA’s regulation of medical devices generally, please contact us at contact@sglawfl.com.

Medical devices are classified under federal law as those products that are “. . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals . . .” and “which [do] not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.” 21 U.S.C. § 321(h). While the FDA explains that the Company’s initial response notes it “did not intend for any of its products to be used in the treatment, cure, mitigation, prevention or diagnosis of any disease,” thus rendering its product outside of the purview of the medical device definition, the FDA reaffirms its stance that the statements made in the Company’s marketing, including its website, cause the product to be considered a medical device. Because products are regulated based on their intended use, it is important to understand the effect that marketing alone may have on the way a product is regulated. More information about the FDA’s regulation of medical devices may be accessed at our previous post, found here.

In addition to understanding how the FDA regulates medical devices, it is critical to understand the FDA’s various enforcement mechanisms, both informal and formal. In particular, warning letters are typically the FDA’s first course of action against companies for alleged non-compliance with the FFDCA and/or FDA regulations. Under the terms of a warning letter, the FDA gives recipients fifteen (15) business days to respond in writing, detailing the specific steps taken to correct violations the FFDCA and accompanying regulations. Firms must respond to all violations, including those not explicitly cited by the Agency, or they may be subject to further agency action, including formal enforcement measures. Because appropriate corrective measures may often preclude further enforcement measures, it is critical to be vigilant when mounting a response to perceived deficiencies in compliance and doing so may help a company remain in business without further issue. For more information about establishing or maintaining compliance with the regulations or laws FDA enforces, please contact us at contact@sglawfl.com.

Like most regulations pertaining to medical devices, the FDA intends to implement the new UDI system using a risk-based approach, meaning that the focus is on devices with the highest risk, i.e., Class III medical devices, and the Agency will exempt low risk, or Class I, devices from some or all of the new regulatory requirements. Similarly, the FDA currently does not require notification prior to the initial distribution of many low risk devices and exempts these devices from various other regulatory requirements. For more information about the UDI system or medical device regulation generally, please contact us at contact@sglawfl.com.

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In 2009, CDRH adopted new policies to aid reviewers in resolving internal scientific disagreements. Prior to the adoption of these policies, CDRH reviewers were directed to discuss such disagreements with supervisors and attempt to resolve issues through informal means. With the implementation of a new Staff Manual Guide, effective January 13, 2009, the FDA directed each individual center to develop its own procedures for resolving scientific disagreements. In October 2009, CDRH published its Standard Operating Procedure (“SOP”) detailing how it would handle these issues. In contrast to the former, the new policy outlines a formal process for resolving scientific issues. According to the procedures, reviewers are encouraged to first discuss any differences in an attempt to reach resolve disagreements. If no resolution can be reached, a reviewer may then take advantage of the new procedures by drafting a memorandum detailing his or her position with respect to the matter. The memorandum will then be evaluated by another party who is not otherwise involved in the review. More information about the new procedures may be accessed here.

As a result of the study, the OIG found that only three of the 36 disagreements occurred after the adoption of the new procedures and that these procedures were used in each of these cases to resolve the disagreements. However, despite the actual implementation of such procedures, the OIG found that more could be done by the CDRH to handle scientific disagreements. In particular, the OIG recommends the FDA:

(1) define more clearly its requirements for documenting and resolving scientific disagreements, (2) train all reviewers and managers on the new policies and procedures for resolving scientific disagreements, and (3) more clearly assign accountability for the contents of the administrative files of all submissions. FDA concurred with our three recommendations.

In its report, OIG noted the FDA’s concurrence with all of the above recommendations. In sum, despite making progress in resolving scientific disagreements in the medical device review process, it appears that the FDA still has its work cut out for it.

The FDA’s regulation of medical devices follows a three-tier approach. Class I devices, or the least-risky devices, typically do not require notification to the FDA prior to marketing. At the other end of spectrum, Class III devices are largely required to undergo the premarket approval (“PMA”) process. While Class II devices typically do not require a PMA, most of these devices must be cleared for marketing by the FDA through the premarket notification (“510(k)”) process. Through this process, device sponsors must notify the FDA of their intent to market a device, while demonstrating that the candidate device is substantially equivalent to a device that has been marketed prior to May 28, 1976 (the date of the Medical Device Amendments) or to devices that have otherwise been reclassified under the Federal Food, Drug and Cosmetic Act (“FFDCA”) and do not require a PMA. More information about the FDA’s classification of medical devices may be found here.

Once a device has received FDA clearance through the 510(k) process, it is then subject to continuing monitoring by the FDA whether through reporting requirements or through adherence to Quality System Regulations (“QSRs”). Additionally, if a device that has been cleared undergoes a modification that bears upon its safety and effectiveness, the device sponsor may need to submit another 510(k) in order to continue legally marketing the device. More information about modifications to cleared devices may be accessed here.