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

Abstract:

Importance:The US Food and Drug Administration approves Class III medical devices via the premarket approval pathway, often requiring clinical data on safety and efficacy. Manufacturers can submit incremental device changes via supplemental applications, which are not subjected to such vetting measures and can cause understudied changes that lead to drift from a device's original design. Objectives:To characterize the postapproval changes to Class III dermatologic devices and to evaluate inconsistencies in the use of the premarket approval pathway. Design, Setting, and Participants:This study was a cross-sectional retrospective cohort analysis of a public US Food and Drug Administration database for premarket approval of devices. Included were dermatologic devices approved by the US Food and Drug Administration between January 1, 1980, and November 1, 2016, through the premarket pathway for device approval. Main Outcomes and Measures:Original devices were identified, and their supplements were characterized chronologically, by review track, and by modification category. Results:The 27 dermatologic devices studied consisted of 14 injectables, 11 photodynamic therapies, a dermal replacement matrix, and a diagnostic imaging instrument. Supplemental applications are increasingly used: the data-requiring panel-track pathway was the least common approach (2.8% [16 of 562 supplements]), while the 30-day track, which does not require clinical data, was most frequently used (42.5% [239 of 562 supplements]). Four devices (14.8%) underwent low-risk recalls (Class II or Class III), and 10 devices (37.0%) were voluntarily withdrawn. Conclusions and Relevance:As manufacturers make increasing use of supplemental applications, minor device changes may occur without supporting clinical data, which could pose a safety risk to patients.

journal_name

JAMA Dermatol

journal_title

JAMA dermatology

authors

Ezaldein HH,Scott JF,Yin ES,Ventura A,DeRuyter NP,Leffell DJ

doi

10.1001/jamadermatol.2017.5757

subject

Has Abstract

pub_date

2018-03-01 00:00:00

pages

273-280

issue

3

eissn

2168-6068

issn

2168-6084

pii

2670028

journal_volume

154

pub_type

杂志文章
  • A Multicenter Cross-Sectional Study and Systematic Review of Necrobiotic Xanthogranuloma With Proposed Diagnostic Criteria.

    abstract:Importance:Necrobiotic xanthogranuloma (NXG) is a non-Langerhans cell histiocytosis classically associated with paraproteinemia attributable to plasma-cell dyscrasias or lymphoproliferative disorders. Despite the morbidity of NXG, the literature is limited to case reports and small studies, and diagnostic criteria are ...

    journal_title:JAMA dermatology

    pub_type: 杂志文章,多中心研究

    doi:10.1001/jamadermatol.2019.4221

    authors: Nelson CA,Zhong CS,Hashemi DA,Ashchyan HJ,Brown-Joel Z,Noe MH,Imadojemu S,Micheletti RG,Vleugels RA,Wanat KA,Rosenbach M,Mostaghimi A

    更新日期:2020-03-01 00:00:00

  • Psoriasis and the risk of diabetes mellitus: a systematic review and meta-analysis.

    abstract:OBJECTIVE:To compare the prevalence and incidence of type 2 diabetes mellitus between patients with psoriasis and those without psoriasis. DATA SOURCES:MEDLINE, EMBASE, and Cochrane Database of Systematic Reviews between January 1, 1980, and January 1, 2012. STUDY SELECTION:Observational (cohort, case-control, and cr...

    journal_title:JAMA dermatology

    pub_type: 杂志文章,meta分析,评审

    doi:10.1001/2013.jamadermatol.406

    authors: Armstrong AW,Harskamp CT,Armstrong EJ

    更新日期:2013-01-01 00:00:00

  • Efficacy and Safety of Baricitinib Combined With Topical Corticosteroids for Treatment of Moderate to Severe Atopic Dermatitis: A Randomized Clinical Trial.

    abstract:Importance:Baricitinib, an oral selective Janus kinase 1 and 2 inhibitor, effectively reduced disease severity in moderate to severe atopic dermatitis (AD) in 2 phase 3 monotherapy studies. Objective:To assess the efficacy and safety of 4 mg and 2 mg of baricitinib in combination with background topical corticosteroid...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2020.3260

    authors: Reich K,Kabashima K,Peris K,Silverberg JI,Eichenfield LF,Bieber T,Kaszuba A,Kolodsick J,Yang FE,Gamalo M,Brinker DR,DeLozier AM,Janes JM,Nunes FP,Thyssen JP,Simpson EL

    更新日期:2020-12-01 00:00:00

  • Paradoxical adipose hyperplasia after cryolipolysis.

    abstract:IMPORTANCE:Cryolipolysis is the noninvasive reduction of fat with localized cutaneous cooling. Since initial introduction, over 650,000 cryolipolysis treatment cycles have been performed worldwide. We present a previously unreported, rare adverse effect following cryolipolysis: paradoxical adipose hyperplasia. OBSERVA...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2013.8071

    authors: Jalian HR,Avram MM,Garibyan L,Mihm MC,Anderson RR

    更新日期:2014-03-01 00:00:00

  • Laser Treatment of Nongenital Verrucae: A Systematic Review.

    abstract:IMPORTANCE:Although cutaneous warts are common lesions, full remission is not always achieved with conventional therapies. Laser modalities including carbon dioxide (CO2), erbium:yttrium-aluminum-garnet (Er:YAG), pulsed dye (PDL), and Nd:YAG have been investigated as alternative treatments for warts. OBJECTIVE:To revi...

    journal_title:JAMA dermatology

    pub_type: 杂志文章,评审

    doi:10.1001/jamadermatol.2016.0826

    authors: Nguyen J,Korta DZ,Chapman LW,Kelly KM

    更新日期:2016-09-01 00:00:00

  • Total Nevi, Atypical Nevi, and Melanoma Thickness: An Analysis of 566 Patients at 2 US Centers.

    abstract:IMPORTANCE:Nevi are among the strongest risk factors for melanoma. However, little is known about the association of many total nevi (TN) or atypical nevi (AN) with tumor thickness. OBJECTIVES:To examine the association between age and the number of TN and AN and to explore whether there was a relationship between TN ...

    journal_title:JAMA dermatology

    pub_type: 杂志文章,多中心研究

    doi:10.1001/jamadermatol.2016.0027

    authors: Geller AC,Mayer JE,Sober AJ,Miller DR,Argenziano G,Johnson TM,Swetter SM

    更新日期:2016-04-01 00:00:00

  • Characterizing the relationship between free drug samples and prescription patterns for acne vulgaris and rosacea.

    abstract:IMPORTANCE:Describing the relationship between the availability of free prescription drug samples and dermatologists' prescribing patterns on a national scale can help inform policy guidelines on the use of free samples in a physician's office. OBJECTIVES:To investigate the relationships between free drug samples and ...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2013.9715

    authors: Hurley MP,Stafford RS,Lane AT

    更新日期:2014-05-01 00:00:00

  • UV-A1 phototherapy vs clobetasol propionate, 0.05%, in the treatment of vulvar lichen sclerosus: a randomized clinical trial.

    abstract:IMPORTANCE:Topical corticosteroids are the current first-line therapy for vulvar lichen sclerosus (VLS). UV-A1 phototherapy may be a promising alternative treatment option, but controlled studies are lacking. OBJECTIVE:To compare the efficacy of high-potent topical corticosteroids with UV-A1 phototherapy in the treatm...

    journal_title:JAMA dermatology

    pub_type: 杂志文章,随机对照试验

    doi:10.1001/jamadermatol.2013.7733

    authors: Terras S,Gambichler T,Moritz RK,Stücker M,Kreuter A

    更新日期:2014-06-01 00:00:00

  • In Vivo Multiphoton Microscopy of Basal Cell Carcinoma.

    abstract:IMPORTANCE:Basal cell carcinomas (BCCs) are diagnosed by clinical evaluation, which can include dermoscopic evaluation, biopsy, and histopathologic examination. Recent translation of multiphoton microscopy (MPM) to clinical practice raises the possibility of noninvasive, label-free in vivo imaging of BCCs that could re...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2015.0453

    authors: Balu M,Zachary CB,Harris RM,Krasieva TB,König K,Tromberg BJ,Kelly KM

    更新日期:2015-10-01 00:00:00

  • Association of Serum Ustekinumab Levels With Clinical Response in Psoriasis.

    abstract:Importance:High-cost biologic therapies have transformed the management of immune-mediated inflammatory diseases. To optimize outcomes and reduce costs, dose adjustment informed by measurement of circulating drug levels has been shown to be effective in various settings. However, limited evidence exists for this approa...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2019.1783

    authors: Tsakok T,Wilson N,Dand N,Loeff FC,Bloem K,Baudry D,Duckworth M,Pan S,Pushpa-Rajah A,Standing JF,de Vries A,Alsharqi A,Becher G,Murphy R,Wahie S,Wright A,Griffiths CEM,Reynolds NJ,Barker J,Warren RB,Burden AD,Ris

    更新日期:2019-09-18 00:00:00

  • Association of Sirolimus Use With Risk for Skin Cancer in a Mixed-Organ Cohort of Solid-Organ Transplant Recipients With a History of Cancer.

    abstract:IMPORTANCE:Solid-organ transplant recipients (OTRs) are at an increased risk for skin cancer. Prior studies have demonstrated a reduced incidence of skin cancer in renal OTRs treated with sirolimus. However, little information exists on the use of sirolimus for the prevention of skin cancer in nonrenal OTRs or those al...

    journal_title:JAMA dermatology

    pub_type: 杂志文章,多中心研究

    doi:10.1001/jamadermatol.2015.5548

    authors: Karia PS,Azzi JR,Heher EC,Hills VM,Schmults CD

    更新日期:2016-05-01 00:00:00

  • Multiple epithelioid Spitz nevi or tumors with loss of BAP1 expression: a clue to a hereditary tumor syndrome.

    abstract:IMPORTANCE:Recently, a group of melanocytic tumors with loss of BAP1 expression has been described. The lesions may occur sporadically or as part of a familial cancer syndrome. They have distinct histopathologic features characterized by a nevus like silhouette and cytologic composition of large epithelioid melanocytes...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2013.1529

    authors: Busam KJ,Wanna M,Wiesner T

    更新日期:2013-03-01 00:00:00

  • Validating 4 Staging Systems for Cutaneous Squamous Cell Carcinoma Using Population-Based Data: A Nested Case-Control Study.

    abstract:Importance:Cutaneous squamous cell carcinoma (cSCC) has metastatic potential, but the prognostic value of current staging systems in nonselected patients is uncertain. Objective:To assess the effect of risk factors for metastasis and to evaluate validity and usefulness of 4 staging systems for cSCC using population-ba...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2017.6428

    authors: Roscher I,Falk RS,Vos L,Clausen OPF,Helsing P,Gjersvik P,Robsahm TE

    更新日期:2018-04-01 00:00:00

  • Prognostic Factors, Treatment, and Survival in Dermatofibrosarcoma Protuberans.

    abstract:Importance:There is limited information regarding the influence of patient demographics, tumor characteristics, and treatment type on the survival of patients with dermatofibrosarcoma protuberans (DFSP). Objective:To assess prognostic factors and to evaluate the influence of treatment modality on overall survival of p...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2016.1886

    authors: Criscito MC,Martires KJ,Stein JA

    更新日期:2016-12-01 00:00:00

  • Detection Accuracy of Collective Intelligence Assessments for Skin Cancer Diagnosis.

    abstract:Importance:Incidence rates of skin cancer are increasing globally, and the correct classification of skin lesions (SLs) into benign and malignant tissue remains a continuous challenge. A collective intelligence approach to skin cancer detection may improve accuracy. Objective:To evaluate the performance of 2 well-know...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2015.3149

    authors: Kurvers RH,Krause J,Argenziano G,Zalaudek I,Wolf M

    更新日期:2015-12-01 00:00:00

  • Immunologic Overlap of Helper T-Cell Subtypes 17 and 22 in Erythrodermic Psoriasis and Atopic Dermatitis.

    abstract:IMPORTANCE:Psoriasis and atopic dermatitis (AD) are inflammatory diseases thought to be mediated by helper T-cell subtypes 1 and 2 (TH1 and TH2), respectively. Although psoriasis and AD show histopathologic differences during chronic disease, they are difficult to distinguish histologically during erythrodermic exacerb...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2015.2

    authors: Moy AP,Murali M,Kroshinsky D,Duncan LM,Nazarian RM

    更新日期:2015-07-01 00:00:00

  • Association of Vitamin D Receptor Polymorphisms With the Risk of Nonmelanoma Skin Cancer in Adults.

    abstract:Importance:Protective effects of UV-B radiation against nonmelanoma skin cancer (NMSC) are exerted via signaling mechanisms involving the vitamin D receptor (VDR). Recent studies have examined single-nucleotide polymorphisms (SNPs) in the VDR, resulting in contradictory findings as to whether these polymorphisms increa...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2017.1976

    authors: Burns EM,Guroji P,Ahmad I,Nasr HM,Wang Y,Tamimi IA,Stiefel E,Abdelgawwad MS,Shaheen A,Muzaffar AF,Bush LM,Hurst CB,Griffin RL,Elmets CA,Yusuf N

    更新日期:2017-10-01 00:00:00

  • A Somatic p.G45E GJB2 Mutation Causing Porokeratotic Eccrine Ostial and Dermal Duct Nevus.

    abstract:IMPORTANCE:Recent data demonstrated somatic mutations in GJB2 that were present in affected porokeratotic eccrine ostial and dermal duct nevus (PEODDN) tissue but absent in unaffected skin. Recognizing that PEODDN lesions can also appear in individuals with keratitis-ichthyosis-deafness syndrome and finding somatic mut...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2014.5069

    authors: Levinsohn JL,McNiff JM,Antaya RJ,Choate KA

    更新日期:2015-06-01 00:00:00

  • Retreatment with omalizumab results in rapid remission in chronic spontaneous and inducible urticaria.

    abstract:IMPORTANCE:Omalizumab has emerged as a novel and effective treatment option for patients with antihistamine-resistant chronic urticaria. It is unclear whether patients with recurrent urticaria symptoms after discontinuation of omalizumab treatment can benefit from retreatment. OBJECTIVE:To assess the response of patie...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2013.8705

    authors: Metz M,Ohanyan T,Church MK,Maurer M

    更新日期:2014-03-01 00:00:00

  • Risk of Serious Infection With Biologic and Systemic Treatment of Psoriasis: Results From the Psoriasis Longitudinal Assessment and Registry (PSOLAR).

    abstract:IMPORTANCE:The efficacy of treatment for psoriasis must be balanced against potential adverse events. OBJECTIVE:To determine the effect of treatment on the risk of serious infections in patients with psoriasis. DESIGN, SETTING, AND PARTICIPANTS:A multicenter, longitudinal, disease-based registry (Psoriasis Longitudin...

    journal_title:JAMA dermatology

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1001/jamadermatol.2015.0718

    authors: Kalb RE,Fiorentino DF,Lebwohl MG,Toole J,Poulin Y,Cohen AD,Goyal K,Fakharzadeh S,Calabro S,Chevrier M,Langholff W,You Y,Leonardi CL

    更新日期:2015-09-01 00:00:00

  • Association of Skin Cancer and Indoor Tanning in Sexual Minority Men and Women.

    abstract:Importance:Skin cancer, the most common cancer in the United States, is highly associated with outdoor and indoor tanning behaviors. Although indoor tanning has been suggested to be more common among sexual minority (self-reported as homosexual, gay, or bisexual) men compared with heterosexual men, whether rates of ski...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2015.3126

    authors: Mansh M,Katz KA,Linos E,Chren MM,Arron S

    更新日期:2015-12-01 00:00:00

  • Autoimmune Diseases in Patients With Cutaneous Lupus Erythematosus.

    abstract:Importance:Increased rates of autoimmune conditions have been reported in association with systemic lupus erythematosus (SLE). Little is known about coexisting autoimmune conditions in patients with cutaneous lupus erythematosus (CLE) without SLE. Objective:To determine the prevalence and risk factors of having coexis...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2018.0616

    authors: Kunzler E,Hynan LS,Chong BF

    更新日期:2018-06-01 00:00:00

  • Association Between the Mental Health of Patients With Psoriasis and Their Satisfaction With Physicians.

    abstract:Importance:How patients' mental health is associated with their satisfaction with physicians is rarely studied among adults with skin conditions. Objective:To examine the association between mental health comorbidities in patients with psoriasis and their satisfaction with physicians. Design, Setting, and Participant...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2020.1054

    authors: Read C,Armstrong AW

    更新日期:2020-07-01 00:00:00

  • Ustekinumab associated with flares of psoriatic arthritis.

    abstract:IMPORTANCE:Ustekinumab is a human monoclonal antibody that binds to the shared p40 subunit of interleukin (IL) 12 and IL-23. It is approved in the United States for adults (>18 years) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. In 1 phase 2 trial of ustekinumab for ...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2013.5728

    authors: Stamell EF,Kutner A,Viola K,Cohen SR

    更新日期:2013-12-01 00:00:00

  • Clinical Features of Neutrophilic Dermatosis Variants Resembling Necrotizing Fasciitis.

    abstract:Importance:Pyoderma gangrenosum and necrotizing Sweet syndrome are diagnostically challenging variants of neutrophilic dermatosis that can clinically mimic the cutaneous and systemic features of necrotizing fasciitis. Improved characterization of these rare variants is needed, as improper diagnosis may lead to inapprop...

    journal_title:JAMA dermatology

    pub_type: 杂志文章,多中心研究

    doi:10.1001/jamadermatol.2018.3890

    authors: Sanchez IM,Lowenstein S,Johnson KA,Babik J,Haag C,Keller JJ,Ortega-Loayza AG,Cohen J,McCalmont TH,Demer AM,Mansh MD,Hylwa SA,Liu J,Shinkai K

    更新日期:2019-01-01 00:00:00

  • Frequency of Primary Nonadherence to Acne Treatment.

    abstract:IMPORTANCE:Treatment outcomes depend on adherence to the prescribed regimen. Primary nonadherence refers to not obtaining and starting to take a prescribed medication. The frequency of primary nonadherence to acne treatment has not been well characterized. The complexity of multidrug acne regimens may add to this probl...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2014.5254

    authors: Anderson KL,Dothard EH,Huang KE,Feldman SR

    更新日期:2015-06-01 00:00:00

  • Dermatopulmonary Syndrome Associated With Anti-MDA5 Antibodies After Allogeneic Hematopoietic Stem Cell Transplantation.

    abstract:Importance:Chronic graft-vs-host-disease (cGVHD) after allogeneic stem cell transplantation (AHSCT) may resemble autoimmune diseases. Anti-MDA5 (melanoma differentiation-associated gene 5) dermatopulmonary syndrome is a subset of dermatomyositis defined by specific clinical features and detection of anti-MDA5-antibodie...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2016.3976

    authors: Lepelletier C,Bengoufa D,Lyes Z,de Masson A,Chasset F,Jachiet M,Michonneau D,Robin M,Peffault de Latour R,Sicre de Fontbrune F,Tandjaoui-Lambiotte Y,Bensussan A,Rybojad M,Tazi A,Bagot M,Socié G,Bergeron A,Bouaziz JD

    更新日期:2017-02-01 00:00:00

  • Purse-string suture vs second intention healing: results of a randomized, blind clinical trial.

    abstract:IMPORTANCE:Purse-string suture is a closure method that purportedly reduces the scar area compared with second intention healing. Randomized clinical trials comparing these 2 methods appear to be limited or absent. OBJECTIVE:To determine if purse-string suture improves cosmetic outcome, healing time, and scar to defec...

    journal_title:JAMA dermatology

    pub_type: 杂志文章,随机对照试验

    doi:10.1001/jamadermatol.2014.2313

    authors: Joo J,Custis T,Armstrong AW,King TH,Omlin K,Kappel ST,Eisen DB

    更新日期:2015-03-01 00:00:00

  • Epidermal Nerve Fiber Quantification in Patients With Erythromelalgia.

    abstract:Importance:Erythromelalgia is a clinical diagnosis based on intermittent warmth, erythema, and pain in the distal extremities. One problem facing physicians is how to objectively test for this disease. Given that other painful conditions of the distal extremities (ie, neuropathy related to human immunodeficiency virus,...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2016.4404

    authors: Mantyh WG,Dyck PJB,Dyck PJ,Engelstad JK,Litchy WJ,Sandroni P,Davis MDP

    更新日期:2017-02-01 00:00:00

  • Hydroxychloroquine-induced pigmentation in patients with systemic lupus erythematosus: a case-control study.

    abstract:IMPORTANCE:Hydroxychloroquine-induced pigmentation is not a rare adverse effect. Our data support the hypothesis that hydroxychloroquine-induced pigmentation is secondary to ecchymosis or bruising. OBJECTIVE:To describe the clinical features and outcome of hydroxychloroquine (HCQ)-induced pigmentation in patients with...

    journal_title:JAMA dermatology

    pub_type: 杂志文章

    doi:10.1001/jamadermatol.2013.709

    authors: Jallouli M,Francès C,Piette JC,Huong du LT,Moguelet P,Factor C,Zahr N,Miyara M,Saadoun D,Mathian A,Haroche J,De Gennes C,Leroux G,Chapelon C,Wechsler B,Cacoub P,Amoura Z,Costedoat-Chalumeau N,Plaquenil LUpus Systemic

    更新日期:2013-08-01 00:00:00