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The Food and Drug Administration's (FDA's) 510(k) Process: A Systematic Review of 1000 Cases

Published:September 25, 2022DOI:https://doi.org/10.1016/j.amjmed.2022.09.006

      Abstract

      Background

      The vast majority of devices cleared by the Food and Drug Administration (FDA) are through the 510(k) process, which allows medical devices to be quickly introduced into the market. The FDA 510(k) process is designed to minimize the burden and expense of bringing new devices to market; however, as a result, the FDA may be limited in its ability to establish the safety of these devices.

      Methods

      The FDA 510(k) online archives were searched for devices cleared from 2013 to 2014. One thousand devices were randomly selected. PubMed was searched for each device to identify publications about the devices. The primary outcome was the percentage of devices cleared through the 510(k) process with no published research. Secondary outcomes included: conflict of interest (COI) of authors and outcomes of published studies on the devices.

      Results

      A total of 6152 devices were cleared through the 510(k) process in 2013-2014. Of the 1000 randomly selected devices, 17.8% had published research. There were 375 manuscripts, of which 47 (12.5%) were randomized controlled trials. One-fourth (25.1%) of studies had a clearly identifiable COI, while COI was unclear for half (49.9%).

      Conclusion and Relevance

      There is limited evidence examining the safety and effectiveness of devices cleared via the 510(k) process. Thousands of devices are cleared through the FDA's 510(k) process each year with limited or no evidence publicly available. This has led to the market being introduced to potentially costly, nonbeneficial, or harmful devices. Devices, like prescription drugs, should undergo a more rigorous clearance process.

      Keywords

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      References

      1. (In)
        Introductory overview.
        in: Hanna KE Manning FJ Bouxsein P Pope A Innovation and Invention in Medical Devices: Workshop Summary. National Academies Press, Washington, DC2001 (Available at) (Accessed October 4, 2022)
      2. EMERGO by UL. USA – Overview of medical device industry and healthcare statistics. Available at: https://www.emergobyul.com/resources/market-united-states. Accessed October 20, 2020.

      3. Drug Watch. FDA 510(k) clearance process. Available at: https://www.drugwatch.com/fda/510k-clearance/. Accessed October 20, 2020.

      4. LaVito A. CNBC. FDA to overhaul more than 40-year-old process for approving medical devices that some say puts consumers at risk. Available at: https://www.cnbc.com/2018/11/26/fda-to-overhaul-510k-medical-device-approval-process.html. Accessed October 20, 2020.

      5. U.S. Food & Drug Administration. CFR - Code of Federal Regulations Title 21. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=807.92. Accessed October 20, 2020.

      6. U.S. Food & Drug Administration. Medical device recalls. Available at:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&event_id=&devicedescriptiontxt=&devicecode=&IVDDevices=&rootCauseText=&recallstatus=&centerclassificationtypetext=&recallnumber=&postdatefrom=&postdateto=&deviceshortreasontxt=&firmlegalnam=&PMA_510K_Num=&pnumber=P000058&knumber=&sortcolumn=cda. Accessed October 20, 2020.

        • Carragee E
        • Mitsunaga K
        • Hurwitz E
        • Scuderi G
        Retrograde ejaculation after anterior lumbar interbody fusion using rhBMP-2: a cohort controlled study.
        Spine J. 2011; 11 (Accessed October 4, 2022): 511-516https://doi.org/10.1016/j.spinee.2011.02.013
      7. U.S. Food & Drug Administration (FDA). Special 510(k) premarket notification. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf2/K022077.pdf. Accessed October 20, 2020.

      8. Enjuris. Stryker Orthopedics hip replacement recalls and lawsuits. Available at: https://www.enjuris.com/hip-surgery/stryker.html. Accessed October 20, 2020.

      9. Office of Inspector General, U.S. Department of Health & Human Services. Shortcomings of device claims data complicate and potentially increase Medicare costs for recalled and prematurely failed devices (A-01-15-00504). Available at: https://oig.hhs.gov/oas/reports/region1/11500504.pdf. Accessed October 4, 2022.

        • Zuckerman D
        • Brown P
        • Das A
        Lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices.
        JAMA Intern Med. 2014; 174 (Available at:) (Accessed October 4, 2022): 1781-1787
      10. U.S. Food and Drug Administration (FDA). 510(k) Premarket notification. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm. Accessed July 15, 2022.

      11. Open Payments. Open payments data highlights. Available at: openpaymentsdata.cms.gov. Accessed July 15, 2022.

      12. Lo B Field MJ Conflict of Interest in Medical Research, Education, and Practice. National Academies Press, Washington, DC2009
      13. U.S. Food & Drug Administration (FDA). MAUDE – Manufacturer and User Facility Device Experience. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm. Accessed October 22, 2021.

        • Cherla DV
        • Viso CP
        • Holihan JL
        • et al.
        The effect of financial conflict of interest, disclosure status, and relevance on medical research from the United States.
        J Gen Intern Med. 2019; 34: 429-434
        • Cherla D
        • Olavarria O
        • Bernardi K
        • et al.
        Investigation of financial conflict of interest among published ventral hernia research.
        J Am Coll Surg. 2018; 226: 230-234
        • Bekelman J
        • Li Y
        • Gross C
        Scope and impact of financial conflicts of interest in biomedical research: a systematic review.
        JAMA. 2003; 289: 454-465
        • Dorsey E
        • de Roulet J
        • Thompson J
        • et al.
        Funding of US biomedical research, 2003-2008.
        JAMA. 2010; 303 (Accessed October 4, 2022): 137-143https://doi.org/10.1001/jama.2009.1987
      14. U.S. Food and Drug Administration (FDA). Emergency use authorization. Available at:https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. Accessed July 15, 2022.

        • Tanaka H
        • Hatta T
        • Sasajima K
        • Itoi E
        • Aizawa T
        Comparative study of treatment for distal radius fractures with two different palmar locking plates.
        J Hand Surg Eur. 2016; 41: 536-542
        • Harris DM
        • Rantalainen T
        • Muthalib M
        • et al.
        Concurrent exergaming and transcranial direct current stimulation to improve balance in people with Parkinson's disease: study protocol for a randomised controlled trial.
        Trials. 2018; 19: 387
        • Lauzé M
        • Martel DD
        • Agnoux A
        • et al.
        Feasibility, acceptability and effects of a home-based exercise program using a gerontechnology on physical capacities after a minor injury in community-living older adults: a pilot study.
        J Nutr Health Aging. 2018; 22: 16-25
        • Wong JC
        • Yang GP
        • Cheung TP
        • Li MK
        Prospective randomized controlled trial comparing partially absorbable lightweight mesh and multifilament polyester anatomical mesh in laparoscopic inguinal hernia repair.
        Asian J Endosc Surg. 2018; 11: 146-150
        • Malfertheiner MV
        • Philipp A
        • Lubnow M
        • et al.
        Hemostatic changes during extracorporeal membrane oxygenation: a prospective randomized clinical trial comparing three different extracorporeal membrane oxygenation systems.
        Crit Care Med. 2016; 44: 747-754
        • Williams GW
        • Gumbert SD
        • Pivalizza EG
        • et al.
        Evaluation and control of waste anesthetic gas in the postanesthesia care unit within patient and caregiver breathing zones.
        Proc (Bayl Univ Med Cent. 2019; 32: 43-49
        • Tallent R
        • Corcoran J
        • Sebastian J
        Evaluation of a novel waste anaesthetic gas scavenger device for use during recovery from anaesthesia.
        Anaesthesia. 2018; 73: 59-64
        • Schuh R
        • Benca E
        • Willegger M
        • et al.
        Comparison of Broström technique, suture anchor repair, and tape augmentation for reconstruction of the anterior talofibular ligament.
        Knee Surg Sports Traumatol Arthrosc. 2016; 24: 1101-1107
        • Reed MJ
        • Grubb NR
        • Lang CC
        • et al.
        Multi-centre randomised controlled trial of a smart phone-based event recorder alongside standard care versus standard care for patients presenting to the Emergency Department with palpitations and pre-syncope – the IPED (Investigation of Palpitations in the ED) study: study protocol for a randomised controlled trial.
        Trials. 2018; 19: 711
        • Eysenck W
        • Freemantle N
        • Sulke N
        A randomized trial evaluating the accuracy of AF detection by four external ambulatory ECG monitors compared to permanent pacemaker AF detection.
        J Interv Card Electrophysiol. 2020; 57: 361-369
        • Thompson 3rd, IM
        • Kappa SF
        • Morgan TM
        • et al.
        Blood loss associated with radical cystectomy: a prospective, randomized study comparing Impact LigaSure vs. stapling device.
        Urol Oncol. 2014; 32 (45.e11-e15)
        • Saini R
        • Cantore S
        • Saini SR
        • Mastrangelo F
        • Ballini A
        • Santacroce L.
        Efficacy of fluorescence technology vs conventional oral examination for the early detection of oral pre-malignant lesions. A clinical comparative study.
        Endocr Metab Immune Disord Drug Targets. 2019; 19: 852-858
        • Colrain IM
        • Black J
        • Siegel LC
        • et al.
        A multicenter evaluation of oral pressure therapy for the treatment of obstructive sleep apnea.
        Sleep Med. 2013; 14: 830-837
        • Biswas S
        • Sambashivaiah S
        • Kulal R
        • Bilichodmath S
        • Kurtzman GM.
        Comparative evaluation of bioactive glass (putty) and platelet rich fibrin in treating furcation defects.
        J Oral Implantol. 2016; 42: 411-415
        • Winny M
        • Maegel L
        • Grethe L
        • et al.
        Adhesion prevention efficacy of composite meshes Parietex®, Proceed® and 4DryField® PH covered polypropylene meshes in an IPOM rat model.
        Int J Med Sci. 2016; 13: 936-941
        • Feldman O
        • Nasrallah N
        • Bitterman Y
        • et al.
        Pediatric intraosseous access performed by emergency department nurses using semiautomatic devices: a randomized crossover simulation study.
        Pediatr Emerg Care. 2021; 37: 442-446
        • Stuart SM
        • Zarow G
        • Walchak A
        • McLean J
        • Roszko P.
        Pilot study of a novel swine model for controlling junctional hemorrhage using the iTClamp in conjunction with hemostatic agents.
        Mil Med. 2019; 184: 367-373
        • Gluck N
        • Fishman S
        • Melhem A
        • Goldfarb S
        • Halpern Z
        • Santo E
        A novel colonoscope with panoramic visualization detected more simulated polyps than conventional colonoscopy in a live swine model.
        Endosc Int Open. 2015; 3: E642-E645
        • Sivardeen A
        • Laughton D
        • Wolffsohn JS
        Randomized crossover trial of silicone hydrogel presbyopic contact lenses.
        Optom Vis Sci. 2016; 93: 141-149
        • Lal A
        • Patterson L
        • Goldrich A
        • Marsh A
        Point-of-care end-tidal carbon monoxide reflects severity of hemolysis in sickle cell anemia.
        Pediatr Blood Cancer. 2015; 62: 912-914
        • Fiore M
        • Ramella S
        • Valeri S
        • et al.
        Phase II study of induction chemotherapy followed by chemoradiotherapy in patients with borderline resectable and unresectable locally advanced pancreatic cancer.
        Sci Rep. 2017; 7: 45845
        • Moon BJ
        • Lee HY
        • Kim KN
        • et al.
        Experimental evaluation of percutaneous lumbar laser disc decompression using a 1414 nm Nd:YAG laser.
        Pain Physician. 2015; 18: E1091-E1099
        • Allardet-Servent J
        • Castanier M
        • Signouret T
        • Soundaravelou R
        • Lepidi A
        • Seghboyan JM
        Safety and efficacy of combined extracorporeal CO2 removal and renal replacement therapy in patients with acute respiratory distress syndrome and acute kidney injury: the pulmonary and renal support in acute respiratory distress syndrome study.
        Crit Care Med. 2015; 43: 2570-2581
        • Scott DF
        Prospective randomized comparison of posterior-stabilized versus condylar-stabilized total knee arthroplasty: final report of a five-year study.
        J Arthroplasty. 2018; 33: 1384-1388
        • Machhindra MV
        • Kang JY
        • Kang YG
        • Chowdhry M
        • Kim TK
        Functional outcomes of a new mobile-bearing ultra-congruent TKA system: comparison with the posterior stabilized system.
        J Arthroplasty. 2015; 30: 2137-2142
        • Akti S
        • Karakus D
        • Sezgin EA
        • Cankaya D
        No differences in clinical outcomes or isokinetic performance between cruciate-substituting ultra-congruent and posterior stabilized total knee arthroplasties: a randomized controlled trial.
        Knee Surg Sports Traumatol Arthrosc. 2021; 29: 3443-3449
        • Perin A
        • Galbiati TF
        • Ayadi R
        • et al.
        Informed consent through 3D virtual reality: a randomized clinical trial.
        Acta Neurochir (Wien). 2021; 163: 301-308
        • Mann EA
        • Salinas J
        The use of computer decision support systems for the critical care environment.
        AACN Adv Crit Care. 2009; 20: 216-219
        • Zealear DL
        • Billante CR
        • Sant'anna GD
        • Courey MS
        • Netterville JL
        Electrically stimulated glottal opening combined with adductor muscle botox blockade restores both ventilation and voice in a patient with bilateral laryngeal paralysis.
        Ann Otol Rhinol Laryngol. 2002; 111: 500-506
        • Devière J
        • Reddy DN
        • Püspök A
        • et al.
        Successful management of benign biliary strictures with fully covered self-expanding metal stents.
        Gastroenterology. 2014; 147: 385-395
        • Seo DW
        • Sherman S
        • Dua KS
        • et al.
        Covered and uncovered biliary metal stents provide similar relief of biliary obstruction during neoadjuvant therapy in pancreatic cancer: a randomized trial.
        Gastrointest Endosc. 2019; 90 (602-612.e4)
        • Kim KM
        • Lee KH
        • Chung YH
        • et al.
        A comparison of bilateral stenting methods for malignant hilar biliary obstruction.
        Hepatogastroenterology. 2012; 59: 341-346
        • Mitwalli H
        • Mourao MDA
        • Dennison J
        • Yaman P
        • Paster BJ
        • Fontana M
        Effect of silver diamine fluoride treatment on microbial profiles of plaque biofilms from root/cervical caries lesions.
        Caries Res. 2019; 53: 555-566
        • Rosenfield K
        • Jaff MR
        • White CJ
        • et al.
        Trial of a paclitaxel-coated balloon for femoropopliteal artery disease.
        N Engl J Med. 2015; 373: 145-153
        • Thoma DS
        • Gamper FB
        • Sapata VM
        • Voce G
        • Hämmerle CH
        • Sailer I.
        Spectrophotometric analysis of fluorescent zirconia abutments compared to “conventional” zirconia abutments: a within subject controlled clinical trial.
        Clin Implant Dent Relat Res. 2017; 19: 760-766
        • Goldstone RN
        • Hasan SR
        • Drury S
        • Darragh TM
        • van Zante A
        • Goldstone SE
        A trial of radiofrequency ablation for anal intraepithelial neoplasia.
        Int J Colorectal Dis. 2017; 32: 357-365
        • Goldstone S
        • Miller J
        • Hasan S.
        A single-center pilot study of ccircumferential anal canal radiofrequency ablation (RFA) to treat anal high-grade dysplasia.
        Open Forum Infect Dis. 2016; 3: 2132
        • Laflamme M
        • Belzile EL
        • Bédard L
        • van den Bekerom MP
        • Glazebrook M
        • Pelet S.
        A prospective randomized multicenter trial comparing clinical outcomes of patients treated surgically with a static or dynamic implant for acute ankle syndesmosis rupture.
        J Orthop Trauma. 2015; 29: 216-223
        • Holzer A
        • Leitgeb U
        • Spacek A
        • Wenzl R
        • Herkner H
        • Kettner S
        Auricular acupuncture for postoperative pain after gynecological surgery: a randomized controlled trail.
        Minerva Anestesiol. 2011; 77: 298-304
        • Romanos GE
        • Malmstrom H
        • Feng C
        • Ercoli C
        • Caton J
        Immediately loaded platform-switched implants in the anterior mandible with fixed prostheses: a randomized, split-mouth, masked prospective trial.
        Clin Implant Dent Relat Res. 2014; 16: 884-892
        • Schoelwer MJ
        • Robic JL
        • Gautier T
        • et al.
        Safety and efficacy of initializing the control-IQ artificial pancreas system based on total daily insulin in adolescents with type 1 diabetes.
        Diabetes Technol Ther. 2020; 22: 594-601
        • Breton MD
        • Kanapka LG
        • Beck RW
        • et al.
        A randomized trial of closed-loop control in children with type 1 diabetes.
        N Engl J Med. 2020; 383: 836-845
        • Cutler J
        • Bikhazi N
        • Light J
        • Truitt T
        • Schwartz M
        • REMODEL Study Investigators
        Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial.
        Am J Rhinol Allergy. 2013; 27: 416-422
        • Alston RP
        • Kitchen C
        • McKenzie C
        • Homer N
        A comparison of the arterial blood concentration of isoflurane during cardiopulmonary bypass between 2 polypropylene oxygenators.
        J Cardiothorac Vasc Anesth. 2020; 34: 1184-1190
        • Andreescu C
        • Glick RM
        • Emeremni CA
        • Houck PR
        • Mulsant BH
        Acupuncture for the treatment of major depressive disorder: a randomized controlled trial.
        J Clin Psychiatry. 2011; 72: 1129-1135
        • Rubin LEH
        • Mist SD
        • Schnyer RN
        • Chao MT
        • Leclair CM
        Acupuncture augmentation of lidocaine for provoked, localized vulvodynia: a feasibility and acceptability study.
        J Low Genit Tract Dis. 2019; 23: 279-286
        • Krieger BR
        • Davis DM
        • Sanchez JE
        • et al.
        The use of silver nylon in preventing surgical site infections following colon and rectal surgery.
        Dis Colon Rectum. 2011; 54: 1014-1019
        • Vanbiervliet G
        • Napoléon B
        • Saint Paul MC
        Core needle versus standard needle for endoscopic ultrasound-guided biopsy of solid pancreatic masses: a randomized crossover study.
        Endoscopy. 2014; 46: 1063-1070
        • Heard KJ
        • Peberdy MA
        • Sayre MR
        • et al.
        A randomized controlled trial comparing the Arctic Sun to standard cooling for induction of hypothermia after cardiac arrest.
        Resuscitation. 2010; 81: 9-14
        • Pitto RP
        • Hamer H
        • Heiss-Dunlop W
        • Kuehle J.
        Mechanical prophylaxis of deep-vein thrombosis after total hip replacement: a randomised clinical trial.
        J Bone Joint Surg Br. 2004; 86: 639-642
        • Colwell Jr, CW
        • Froimson MI
        • Mont MA
        • et al.
        Thrombosis prevention after total hip arthroplasty: a prospective, randomized trial comparing a mobile compression device with low-molecular-weight heparin.
        J Bone Joint Surg Am. 2010; 92: 527-535
        • Meneveau N
        • Souteyrand G
        • Motreff P
        • et al.
        Optical coherence tomography to optimize results of percutaneous coronary intervention in patients with non–ST-elevation acute coronary syndrome: results of the multicenter, randomized DOCTORS study (Does Optical Coherence Tomography Optimize Results of Stenting).
        Circulation. 2016; 134: 906-917
        • Daya S
        • Chee SP
        • Ti SE
        • Packard R
        • Mordaunt DH
        Comparison of anterior capsulotomy techniques: continuous curvilinear capsulorhexis, femtosecond laser-assisted capsulotomy and selective laser capsulotomy.
        Br J Ophthalmol. 2020; 104: 437-442
        • Chugh AJ
        • Pace JR
        • Singer J
        • et al.
        Use of a surgical rehearsal platform and improvement in aneurysm clipping measures: results of a prospective, randomized trial.
        J Neurosurg. 2017; 126: 838-844
        • Snyder MA
        • Sympson AN
        • Scheuerman CM
        • Gregg JL
        • Hussain LR
        Efficacy in deep vein thrombosis prevention with extended mechanical compression device therapy and prophylactic aspirin following total knee arthroplasty: a randomized control trial.
        J Arthroplasty. 2017; 32: 1478-1482
        • te Pas AB
        • Lopriore E
        • Dito I
        • Morley CJ
        • Walther FJ
        Humidified and heated air during stabilization at birth improves temperature in preterm infants.
        Pediatrics. 2010; 125: e1427-e1432
        • Goossens GA
        • Verbeeck G
        • Moons P
        • Sermeus W
        • De Wever I
        • Stas M
        Functional evaluation of conventional ‘Celsite®’venous ports versus ‘Vortex®’ports with a tangential outlet: a prospective randomised pilot study.
        Support Care Cancer. 2008; 16: 1367-1374
        • Uygur O
        • Yalaz M
        • Can N
        • Koroglu OA
        • Kultursay N
        Preterm infants may better tolerate feeds at temperatures closer to freshly expressed breast milk: a randomized controlled trial.
        Breastfeed Med. 2019; 14: 154-158
        • Whooley S
        • Briskin T
        • Gibney MA
        • Blank LR
        • Berube J
        • Pflug BK
        Evaluating the user performance and experience with a re-engineered 4 mm × 32G pen needle: a randomized trial with similar length/gauge needles.
        Diabetes Ther. 2019; 10: 697-712