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.

References

References
2.
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
3.
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
4.
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
5.
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
.10.1115/1.4006781
6.
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
7.
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
8.
Questionnaire Design Principles
,”
National Cancer Institute, National Institutes of Health
, http://appliedresearch.cancer.gov/areas/cognitive/
9.
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
10.
U.S. Food and Drug Administration
,
2011
, “
FDA Announces New Staff Training for Medical Device Reviewers
,” www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm270858.htm
11.
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
12.
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
13.
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
14.
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
15.
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
16.
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
17.
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
18.
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
19.
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
20.
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
21.
U.S. Food and Drug Administration
,
1986
, “
Guidance on the CDRH Premarket Notification Review Program
,” 510(k) Memorandum No. K86-3.
22.
Center for Devices and Radiological Health
,
1998
, “
The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications
,”
FDA, Rockville, MD
.
You do not currently have access to this content.