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Research Paper

Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience—Part 2: Medical Device Ecosystem and Policy

[+] Author and Article Information
Jan B. Pietzsch

Wing Tech Inc.,
42808 Christy Street, Suite 230,
Fremont, CA 94538;
Stanford University Program in Biodesign,
James H. Clark Center,
Stanford University,
318 Campus Drive, E-100,
Stanford, CA 94305-5428
e-mail: jpietzsch@wing-tech.com

Marta G. Zanchi

Medinnovo LLC,
333 West Santa Clara Street,
San Jose, CA 95113;
Wing Tech Inc.,
42808 Christy Street, Suite 230,
Fremont, CA 94538
e-mail: mgzanchi@medinnovo.com

John H. Linehan

Department of Biomedical Engineering,
Robert R. McCormick School of Engineering and Applied Science,
Northwestern University,
2145 Sheridan Road,
Evanston, IL 60208;
Stanford University Program in Biodesign,
James H. Clark Center,
Stanford University,
318 Campus Drive, E-100,
Stanford, CA 94305-5428
e-mail: linehan@northwestern.edu

Manuscript received May 23, 2012; final manuscript received November 21, 2012; published online June 24, 2013. Editor: Gerald E. Miller.

J. Med. Devices 7(2), 021003 (Jun 24, 2013) (5 pages) Paper No: MED-12-1074; doi: 10.1115/1.4023131 History: Received May 23, 2012; Revised November 21, 2012

The FDA 510(k) clearance process is the most common regulatory pathway for medical devices. Since 2010, it has been at the forefront of regulatory policy discussion, with a multitude of stakeholders involved in a substantive exchange of ideas about the need and opportunities for improving the process and its implementation. This article is the second in a two-part series reporting the findings of a questionnaire-based assessment of recent industry experience with the 510(k) process. While the first article focused on findings directly relating to the medical device innovation process, this article reports more broadly on the findings and implications of interest to the medical community and policymakers. We discuss results in five key areas, ranging from the current performance of the 510(k) regulatory process to proposed changes and suggested performance metrics, and place identified challenges in perspective with ongoing and forthcoming FDA actions. Through the survey we also report on current trends in the amount of clinical evidence required by FDA for 510(k) devices and on the interactions between sponsors and the agency during various phases of clinical testing. The results suggest that significant opportunities exist for both industry and FDA to further improve the 510(k) process and the effectiveness of its implementation. Continued collection of process performance data can contribute to prioritizing suggested policy changes, and gauging their effects in a timely manner.

Copyright © 2013 by ASME
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References

Code of Federal Regulations, 2008, “Premarket Approval of Medical Devices,” Federal Food, Drug, and Cosmetic Act (21 CFR 814, subpart A), www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=814&showfr=1 &subpartnode=21:8.0.1.1.11.1
U.S. Government Accountability Office, 2009, “FDA Should Take Steps to Ensure That High-Risk Device Types are Approved Through the Most Stringent Premarket Review Process,” GAO Report to Congressional Addressees GAO-09-190, www.gao.gov/new.items/d09190.pdf
Code of Federal Regulations, 2011, “Humanitarian Use Devices,” Federal Food, Drug, and Cosmetic Act (21 CFR 814, subpart H), www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=814&showFR=1 &subpartNode=21:8.0.1.1.11.7
Pietzsch, J. B., Zanchi, M. G., and Linehan, J. H., 2012, “Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience,” ASME J. Med. Devices, 6(2), p. 021015. [CrossRef]
Makower, J., Meer, A., and Denend, L., 2010, “FDA Impact on U.S. Medical Technology Innovation: A Survey of Over 200 Medical Technology Companies,” Advanced Medical Technology Association, Washington, DC, available at: http://www.advamed.org/NR/rdonlyres/040E6C33-380B-4F6B-AB58-9AB1C0A7A3CF/0/makowerreportfinal.pdf
Makower, J., 2010, “The Structure of the MedTech Innovation Ecosystem,” Presentation to Meeting of the IOM Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, Washington, DC, June 14, http://iom.edu/∼/media/Files/Activity%20Files/PublicHealth/510kProcess/2010-JUN-14/Presentations/14%20Makower.pdf
“Questionnaire Design Principles,” National Cancer Institute, National Institutes of Health, http://appliedresearch.cancer.gov/areas/cognitive/
U.S. Food and Drug Administration, 2011, “Analysis of Premarket Review Times Under the 510(k) Program,” www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhreports/ucm263385.htm
U.S. Food and Drug Administration, 2011, “FDA Announces New Staff Training for Medical Device Reviewers,” www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm270858.htm
U.S. Food and Drug Administration, 2011, “Network of Experts: Expert Utilization Standard Operating Procedure (Draft),” www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhreports/ucm271521.htm
U.S. Food and Drug Administration, 2011, “SOP: Management of Review Staff Changes During the Review of a Premarket Submission,” www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhreports/ucm285034.htm
U.S. Food and Drug Administration, 2012, “Accomplishments: CDRH Plan of Action for 510(k) and Science,” www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhreports/ucm276286.htm
U.S. Food and Drug Administration, 2011, “SOP: Decision Authority for Additional or Changed Data Needs for Premarket Submissions,” www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhreports/ucm279288.htm
U.S. Food and Drug Administration, 2011, “CDRH Center Science Council Charter,” July 1, 2011, www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhreports/ucm249248.htm
U.S. Food and Drug Administration, 2011, “CDRH Preliminary Internal Evaluations, Volume I: 510(k) Working Group, Preliminary Report and Recommendations,” www.fda.gov/downloads/aboutfda/centersoffices/cdrh/cdrhreports/ucm220784.pdf
U.S. Food and Drug Administration, 2011, “Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff: Design Considerations for Pivotal Clinical Investigations for Medical Devices,” www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm265553.htm
U.S. Food and Drug Administration, 2011, “Draft Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies,” www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm277670.htm
U.S. Food and Drug Administration, 2011, “Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff: FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations,” www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm277669.htm
U.S. Food and Drug Administration, 2011, “Draft Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)],” www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm282958.htm
U.S. Food and Drug Administration, 1986, “Guidance on the CDRH Premarket Notification Review Program,” 510(k) Memorandum No. K86-3.
Center for Devices and Radiological Health, 1998, “The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications,” FDA, Rockville, MD.

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