FDA Draft Guidance Points Upward For OTC Wellness Device Development

The decision algorithm and flexible approach in a draft guidance on general wellness products will support innovative mobile health development, an industry advocate says. FDA does not intend to review low-risk OTC products, such as exercise equipment, that claim to support various facets of patients' wellness.

Medical product firms’ interest in developing and launching over-the-counter wellness-focused devices could get a boost from FDA’s recent draft guidance on general wellness products.

The draft guidance issued Jan. 20 says the agency does not intend to review OTC products, such as exercise equipment, audio recordings, video games, and mobile health applications, that claim to support various facets of patients' wellness as long as they are considered low-risk devices.

“A general wellness product, for the purposes of this guidance, has (1) an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity, or (2) 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 and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition,” states the draft.

The proposed guidance breaks general wellness products into two permissible categories: products that make claims about sustaining or improving a person’s health but do not make any references to diseases or conditions; and products that promote healthier lifestyles that may help reduce the risk of or improve living with certain chronic diseases or conditions.

“I really love this guidance. FDA truly listened to the public in crafting this guidance,” said Bradley Thompson, who heads the mHealth Regulatory Coalition. “

The wellness draft and a draft guidance issued in parallel on device accessories are part of FDA's commitment to detail how it plans to oversee mobile devices using a risk-based approach. An accessory is considered to be a device intended to support, supplement, and/or augment the use of a parent device.

The accessories draft guidance clarifies that accessories "will be regulated based on the risks they present when used as intended with their parent devices and not based on the risks of their parent devices," according to an FDA summary (see story in “The Tan Sheet” online, “Accessorize At Your Own Risk: Draft Guidance Clarifies Regs For Device Add-Ons”).

Guide To Innovation

The mHealth Coalition asked FDA not to produce a guidance only with a list of examples, but to provide clear rules on how it distinguishes general wellness products.

The agency accomplished that, Thompson said, with a decision algorithm in both draft guidances to help firms better determine if a product falls under FDA’s definition of a wellness product.

“We need rules to guide the truly innovative stuff that we haven’t thought of yet,” Thompson said.

The coalition also recommended FDA use the concept of “general recognition,” which the agency follows when evaluating food and drugs, as a basis for not regulating claims that have strong scientific validity.

“That’s exactly what FDA proposes to do. No longer does the mere mention of a disease in promotional materials mean that FDA may regulate it,” said Thompson. “FDA has chosen to draw a very common sense line that avoids regulating products that help people manage common chronic diseases.”

FDA says it will determine if a product is low risk based on whether it is invasive, involves an intervention or technology that may pose a risk to a user’s safety if device controls are not applied, raises novel questions of usability, or raises questions of biocompatibility.

Thompson says the approach seems reasonable, but adds he is not sure what the agency means by devices that raise novel questions of usability. “Usability is a pretty broad concept, and includes some pretty benign characteristics,” he said.

Thompson observed, though, that an unfortunate aspect of the guidance is it was produced only by CDRH, without participation by other FDA offices such as the drug center.

He said while getting input from other centers might have complicated the process, it is an important consideration, particularly for drug-device combination products, including innovate Rx-to-OTC switch proposals, aimed at improving general wellness and treating chronic conditions, such as smoking cessation products (Also see "Combo Products Guidance Could Help Point Novel OTC Switches In Right Direction" - Pink Sheet, 23 Feb, 2015.).

“So on the one hand, after years of waiting for this guidance, I’m grateful that CDRH did not wait any longer to try to bring the other centers on board. But on the other hand, I’m always a bit sad when policymaking is done piecemeal. I really hope this does not mean that the other centers are on a different page,” said Thompson.

Comments on the draft guidance, docket number FDA-2014-N-1039, are due by April 20.