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.

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 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.