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.

In the recently published FDA guidance, the FDA is instructing its staff not to consider “general wellness products” as “devices” for purposes of the FDCA, meaning that these low risk devices will not have the considerable oversight that other “devices” receive from the FDA. The proposed guidance document defines a “general wellness product” as meeting a two-factor test. First, that the products are intended for only general wellness use, as defined in this guidance. Second, that the products present a very low risk to users’ safety. However, the decision by the FDA not to regulate these products does not mean that those classes of products are safe, effective, and not misbranded for its intended use.

General Wellness Products

For a product to be classified as a general wellness product, it must meet one of two criteria:

1. It must have, “an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity;” or

2. It must have an, “intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of                  certain chronic diseases or conditions…”

General wellness products are allowed to make claims about improving a general state of health, but they must not make any references to diseases or conditions. General wellness products are only allowed to make references to diseases or conditions when it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition. This means that generally accepted science has proven that healthy lifestyle choices may play an important role in health outcomes.

Low Risk Devices

If a product presents an inherent risk to the safety of the user, then it is not exempted by this guidance document. If a product does any of the following four things, then it is not a low risk product for purposes of this guidance document and is not considered a general wellness product if:

1. the product is invasive;

2. the low risk device involves an intervention or technology that may pose a risk to a user’s safety if device controls are not                    applied, such as risks from lasers, radiation exposure, or implants;

3. it raises novel questions of usability, or

4. if the low risk device raises questions of biocompatibility.

This guidance document is an interesting stance from the FDA insomuch as the FDA is taking a self-limiting position by essentially saying that the Agency should not be regulating these devices. Rarely does the FDA take such a self-limiting stance on issues of product regulation. However, just because the FDA is not regulating these General Wellness products, it does not mean that they are completely unregulated. The Consumer Product Safety Commission (CPSC) may also have the authority to decide whether a general wellness product is a consumer product under CPSC’s authority vested in it by the Consumer Product Safety Act. Accordingly, how this guidance document and federal law will be applied in practice remains to be seen.

A guidance document serves as the Agency’s official stance on a subject. Further, it does not create any legally enforceable duties upon the Agency. It solely guides the decision makers within an agency to uniformly apply the specified laws and regulations. This proposed guidance document is open to public comment before it becomes final. Currently, electronic comments can be sent to the FDA at this website. The public comment period is open for 90 days, and then the Agency will review all of the comments that are received and will finalize the guidance document.

Navigating the web of regulations and regulatory bodies can be a daunting task. When selling or distributing a product, a company must be absolutely certain that they are meeting all regulatory requirements or risk enforcement action. If you think your product may be affected by the new guidance document and want to be sure your claims and labeling are in compliance or see how you may be regulated by FDA, our office offers reviews of product labels and health claims. If you have any questions about the new guidance document or whether your product is considered a “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

Section 519(f) of the Food, Drug, and Cosmetic Act (FDCA), provided for by the FDA Amendments Act of 2007 and the FDA Safety and Innovation Act of 2012, directs FDA to promulgate regulations establishing a unique device identification system for medical devices. Under the new UDI system, device manufacturers will be required to assign a unique identifier to the version or model of a device. This identifier, which must appear on the label and packaging of the device in “plain-text” form, will include a numeric or alphanumeric code and product-specific information such as the batch number and expiration date.

Additionally, the final rule requires that device labelers submit descriptive information about each version or model of a device with a UDI to the Global Unique Device Identification Database (GUDID) as part of the UDI system. Similar to the system in place for drugs, GUDID will be a publicly searchable database administered by the FDA and it will contain key descriptive information about every medical device with an identifier. The FDA has published draft guidance for industry outlining the process for submitting information to the GUDID.

In sum, medical devices must be in compliance with the rule’s provisions by the dates listed in the text, which calls for staggered implementation for unique device identification. One year after publication, for example, labels and packages of Class III medical devices and devices licensed under the Public Health Services Act must bear a UDI. The final rule also identifies general exceptions from the requirement for a label of a device to bear a UDI and describes the process for other labelers to request an exception or alternative placement of the UDI. Many low risk (Category I) devices are exempt from some or all of the rule’s requirements.

If you have any questions about the UDI system or any medical device 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.

Pursuant to its involvement in Operation Pangea V, the FDA notes that it sent Warning Letters to the operators of over 4,100 different online pharmacies’ websites deemed to be selling products in violation of U.S. law. 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 often preclude further enforcement, it is critical to be vigilant when mounting a response to perceived deficiencies in compliance. For more information about establishing or maintaining compliance with the laws or regulations FDA enforces, please contact us at contact@sglawfl.com.

]]> https://giannamore-law.com/fda-proposes-new-unique-identifier-system-for-medical-devices/?utm_source=rss&utm_medium=rss&utm_campaign=fda-proposes-new-unique-identifier-system-for-medical-devices Tue, 17 Jul 2012 01:07:13 +0000 http://giannamore-law.com/?p=242 On July 3, 2012, the U.S. Food and Drug Administration (“FDA”) announced its intention to require most medical devices in the United States to bear a Unique Device Identifier (“UDI”). According to the FDA, this UDI system could potentially improve availability and quality of information in medical device adverse event reporting and in the event of product recalls. Under the text of the Proposed Rule, published in the Federal Register on July 10, 2012, a UDI will include a unique numeric or alphanumeric code identifying the specific device model and a production identifier, containing the current production information for the device. The FDA will be seeking comments on the Proposed Rule until November 7, 2012. Comments to the proposal may be made here.

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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The approval of an at-home HIV test kit marks a milestone with respect to HIV testing. Before today, the FDA has only approved HIV tests to be used by trained practitioners in medical settings. In fact, OraSure Technologies, Inc., the manufacturer of the OraQuick In-Home HIV Test, was first approved in 2004 for use in clinical settings by trained professionals. Devices associated with blood donor testing, like the one FDA test kit here, must secure FDA authorization through the Premarket Approval (“PMA”) process. Through this process, the FDA approves products for only those specific conditions and/or uses listed in the product labeling. Thus, while similar tests have been available on the market, this is the first time these tests may be marketed and sold to the public for use in the home.

For more information about the PMA process or other regulatory issues, please feel contact us here.