The US Food and Drug Administration’s Approach for Safe Innovation of Medical Devices in Dermatology

Abstract

With the increased awareness of skin conditions and demand for aesthetic treatments requiring the expertise of dermatologists, there has been a growth in the associated medical device industry. Dermatology medical devices include point-of-care diagnostics, ablative technologies, skin imaging devices, dermal fillers, lasers, and wound dressings. Many new devices in dermatology offer practitioners and patients additional options for a variety of conditions including diabetic wound care, skin lesion screening, and alopecia treatment.The Center for Devices and Radiological Health in the US Food and Drug Administration (FDA) is charged with keeping pace with medical device innovation while at the same time ensuring that all medical devices-new and existing-are safe and effective for patients who may benefit from them. Although the FDA does not itself test new devices, it evaluates the data submitted by manufacturers before allowing the device on the US market. Depending on the risk of the device and the existing body of evidence available for similar devices, the level of testing data provided is variable, ranging from simple technological comparisons to prospective, randomized, clinical trials.The FDA provides its most rigorous oversight of devices that, based on their benefits and risks, are considered class III devices. These devices present the highest level of risk for medical devices and require premarket approval (PMA). While there are other regulatory pathways to bring medical devices to market, the purpose of this editorial is to give dermatologists an understanding of each of the different types of PMA applications for new and modified class III devices.For a new device, an original PMA application containing clinical and preclinical data is submitted to the FDA for review. When the advice of a panel of experts would be beneficial to the FDA's regulatory decision making, PMA applications are referred for public discussion at a meeting of the Medical Devices Advisory Committee. 1 Every year many PMA supplements, which represent modifications to devices approved through original PMA applications, are submitted for review. 2 Some modifications involve newer models or expanded indications. However, many more PMA supplements incorporate minor modifications, for example, to the packaging or manufacturing equipment for an approved device. The types of supplements required for certain modifications and the nature of the data typically provided are described in an FDA guidance document, 3 and summarized in Table 1. PMA (180 d) SupplementSignificant change in components, materials, design, specification, software, color additives, or labeling PMA Real-time Supplement Minor change to the device design, software, sterilization, or labeling with prior US Food and Drug Administration determination that a Real-time Supplement is appropriate

Dermatologic Device Clearance Within the Food and Drug Administration's 510(k) Pathway

“…Although there is a lot of industry influence, which may represent the aforementioned conflicts‐of‐interest, there may be opportunities for increased dermatologic involvement at the FDA. Dermatologists are encouraged to serve on FDA advisory committees, provide expert advice, and help streamline adverse outcome reporting to improve patient safety [43].…”