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
- (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)
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.
Drug Watch. FDA 510(k) clearance process. Available at: https://www.drugwatch.com/fda/510k-clearance/. Accessed October 20, 2020.
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.
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.
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=¢erclassificationtypetext=&recallnumber=&postdatefrom=&postdateto=&deviceshortreasontxt=&firmlegalnam=&PMA_510K_Num=&pnumber=P000058&knumber=&sortcolumn=cda. Accessed October 20, 2020.
- 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
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.
Enjuris. Stryker Orthopedics hip replacement recalls and lawsuits. Available at: https://www.enjuris.com/hip-surgery/stryker.html. Accessed October 20, 2020.
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.
- 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
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.
Open Payments. Open payments data highlights. Available at: openpaymentsdata.cms.gov. Accessed July 15, 2022.
- Lo B Field MJ Conflict of Interest in Medical Research, Education, and Practice. National Academies Press, Washington, DC2009
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.
- 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
- Investigation of financial conflict of interest among published ventral hernia research.J Am Coll Surg. 2018; 226: 230-234
- Scope and impact of financial conflicts of interest in biomedical research: a systematic review.JAMA. 2003; 289: 454-465
- Funding of US biomedical research, 2003-2008.JAMA. 2010; 303 (Accessed October 4, 2022): 137-143https://doi.org/10.1001/jama.2009.1987
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.
- Comparative study of treatment for distal radius fractures with two different palmar locking plates.J Hand Surg Eur. 2016; 41: 536-542
- 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
- 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
- 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
- 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
- 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
- Evaluation of a novel waste anaesthetic gas scavenger device for use during recovery from anaesthesia.Anaesthesia. 2018; 73: 59-64
- 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
- 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
- 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
- Blood loss associated with radical cystectomy: a prospective, randomized study comparing Impact LigaSure vs. stapling device.Urol Oncol. 2014; 32 (45.e11-e15)
- 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
- A multicenter evaluation of oral pressure therapy for the treatment of obstructive sleep apnea.Sleep Med. 2013; 14: 830-837
- Comparative evaluation of bioactive glass (putty) and platelet rich fibrin in treating furcation defects.J Oral Implantol. 2016; 42: 411-415
- 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
- Pediatric intraosseous access performed by emergency department nurses using semiautomatic devices: a randomized crossover simulation study.Pediatr Emerg Care. 2021; 37: 442-446
- 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
- 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
- Randomized crossover trial of silicone hydrogel presbyopic contact lenses.Optom Vis Sci. 2016; 93: 141-149
- Point-of-care end-tidal carbon monoxide reflects severity of hemolysis in sickle cell anemia.Pediatr Blood Cancer. 2015; 62: 912-914
- 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
- Experimental evaluation of percutaneous lumbar laser disc decompression using a 1414 nm Nd:YAG laser.Pain Physician. 2015; 18: E1091-E1099
- 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
- 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
- Functional outcomes of a new mobile-bearing ultra-congruent TKA system: comparison with the posterior stabilized system.J Arthroplasty. 2015; 30: 2137-2142
- 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
- Informed consent through 3D virtual reality: a randomized clinical trial.Acta Neurochir (Wien). 2021; 163: 301-308
- The use of computer decision support systems for the critical care environment.AACN Adv Crit Care. 2009; 20: 216-219
- 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
- Successful management of benign biliary strictures with fully covered self-expanding metal stents.Gastroenterology. 2014; 147: 385-395
- 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)
- A comparison of bilateral stenting methods for malignant hilar biliary obstruction.Hepatogastroenterology. 2012; 59: 341-346
- Effect of silver diamine fluoride treatment on microbial profiles of plaque biofilms from root/cervical caries lesions.Caries Res. 2019; 53: 555-566
- Trial of a paclitaxel-coated balloon for femoropopliteal artery disease.N Engl J Med. 2015; 373: 145-153
- 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
- A trial of radiofrequency ablation for anal intraepithelial neoplasia.Int J Colorectal Dis. 2017; 32: 357-365
- 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
- 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
- Auricular acupuncture for postoperative pain after gynecological surgery: a randomized controlled trail.Minerva Anestesiol. 2011; 77: 298-304
- 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
- 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
- A randomized trial of closed-loop control in children with type 1 diabetes.N Engl J Med. 2020; 383: 836-845
- Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial.Am J Rhinol Allergy. 2013; 27: 416-422
- A comparison of the arterial blood concentration of isoflurane during cardiopulmonary bypass between 2 polypropylene oxygenators.J Cardiothorac Vasc Anesth. 2020; 34: 1184-1190
- Acupuncture for the treatment of major depressive disorder: a randomized controlled trial.J Clin Psychiatry. 2011; 72: 1129-1135
- Acupuncture augmentation of lidocaine for provoked, localized vulvodynia: a feasibility and acceptability study.J Low Genit Tract Dis. 2019; 23: 279-286
- The use of silver nylon in preventing surgical site infections following colon and rectal surgery.Dis Colon Rectum. 2011; 54: 1014-1019
- Core needle versus standard needle for endoscopic ultrasound-guided biopsy of solid pancreatic masses: a randomized crossover study.Endoscopy. 2014; 46: 1063-1070
- A randomized controlled trial comparing the Arctic Sun to standard cooling for induction of hypothermia after cardiac arrest.Resuscitation. 2010; 81: 9-14
- Mechanical prophylaxis of deep-vein thrombosis after total hip replacement: a randomised clinical trial.J Bone Joint Surg Br. 2004; 86: 639-642
- 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
- 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
- Comparison of anterior capsulotomy techniques: continuous curvilinear capsulorhexis, femtosecond laser-assisted capsulotomy and selective laser capsulotomy.Br J Ophthalmol. 2020; 104: 437-442
- Use of a surgical rehearsal platform and improvement in aneurysm clipping measures: results of a prospective, randomized trial.J Neurosurg. 2017; 126: 838-844
- 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
- Humidified and heated air during stabilization at birth improves temperature in preterm infants.Pediatrics. 2010; 125: e1427-e1432
- 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
- Preterm infants may better tolerate feeds at temperatures closer to freshly expressed breast milk: a randomized controlled trial.Breastfeed Med. 2019; 14: 154-158
- 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
Article info
Publication history
Published online: September 25, 2022
Footnotes
Funding: The authors received no external funding support for this manuscript.
Conflicts of Interest: The authors have no conflict of interest to disclose.
Authorship: All authors had access to the data and a role in writing the manuscript.
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