Transparency and Dermatologic Device Approval by the US Food and Drug Administration

Ezaldein, Harib H.; Scott, Jeffrey F.; Yin, Emily S.; Ventura, Alessandra; DeRuyter, Nicholaas P.; Leffell, David J.

doi:10.1001/jamadermatol.2017.5757

Cited by 5 publications

(3 citation statements)

References 27 publications

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“…‘Minor’ procedure modifications were consistent with smaller technical modifications within an accepted procedure, requiring less extensive surgeon training. For surgical devices, articles referred to ‘minor’ device modifications such as smaller design changes, in contrast to ‘major’ device modifications that might include new indications for use 32 .…”

Section: Resultsmentioning

confidence: 99%

Development of a conceptual framework for reporting modifications in surgical innovation: scoping review

et al. 2023

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Background Innovative surgical procedures and devices are often modified throughout their development and introduction into clinical practice. A systematic approach to reporting modifications may support shared learning and foster safe and transparent innovation. Definitions of ‘modifications’, and how they are conceptualized and classified so they can be reported and shared effectively, however, are lacking. This study aimed to explore and summarize existing definitions, perceptions, classifications and views on modification reporting to develop a conceptual framework for understanding and reporting modifications. Methods A scoping review was conducted in accordance with PRISMA Extension for Scoping Reviews (PRISMA-ScR) guidelines. Targeted searches and two database searches were performed to identify relevant opinion pieces and review articles. Included were articles relating to modifications to surgical procedures/devices. Data regarding definitions, perceptions and classifications of modifications, and views on modification reporting were extracted verbatim. Thematic analysis was undertaken to identify themes, which informed development of the conceptual framework. Results Forty-nine articles were included. Eight articles included systems for classifying modifications, but no articles reported an explicit definition of modifications. Some 13 themes relating to perception of modifications were identified. The derived conceptual framework comprises three overarching components: baseline data about modifications, details about modifications and impact/consequences of modifications. Conclusion A conceptual framework for understanding and reporting modifications that occur during surgical innovation has been developed. This is a first necessary step to support consistent and transparent reporting of modifications, to facilitate shared learning and incremental innovation of surgical procedures/devices. Testing and operationalization is now needed to realize the value of this framework.

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Section: Resultsmentioning

confidence: 99%

Development of a conceptual framework for reporting modifications in surgical innovation: scoping review

et al. 2023

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“…Class II devices, which typically include wound dressings, laser, cryogenic, and ultraviolet devices, are considered the moderate risk and are subject to 510(k) regulation. Class III devices, including injectable fillers, are deemed high‐risk and typically require premarket approval based on clinical trial data [6–8].…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2020

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Background and Objectives: Device innovation in dermatology is increasing. Medical devices identified as "substantially equivalent" to predicate ones by the United States Food and Drug Administration (FDA) may be exempt from premarket approval through the 510(k) pathway. The 510(k) pathway has been criticized for having less stringent clinical data requirements, and implications of dermatologic device clearance via this pathway are incompletely described. The objective of this study is to characterize dermatologic device clearance via the 510(k) pathway. Study Design/Materials and Methods: We performed a retrospective review of the FDA's 510(k) database between January 1, 1996 and December 31, 2018. Dermatologic devices were included based on product code and classified by the application. Approval pathways and decision characteristics were compared among dermatologic device categories. Results: Of the 76,607 records screened, 4,637 met inclusion criteria. Laser/thermal devices comprised the largest category (64.2%), followed by wound (24.0%) and light-based devices (5.8%). The majority of 510(k) pathway submissions were traditional (89.2%) compared with alternative (10.8%) submission types (P = 0.003). Devices that were deemed substantially equivalent without limitations (98.5%) were the most common among all device categories. Rates of device clearance over the study period increased for all categories except laser/ thermal devices. Conclusions: Dermatologic devices are increasingly cleared via the FDA's 510(k) pathway through "substantial equivalence" with minimal requirements for premarket clinical data. Lasers Surg. Med.

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“…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 . Every year many PMA supplements, which represent modifications to devices approved through original PMA applications, are submitted for review . Some modifications involve newer models or expanded indications.…”

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confidence: 99%

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

2018

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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

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Transparency and Dermatologic Device Approval by the US Food and Drug Administration

Cited by 5 publications

References 27 publications

Development of a conceptual framework for reporting modifications in surgical innovation: scoping review

Development of a conceptual framework for reporting modifications in surgical innovation: scoping review

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

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

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