Medical device regulation plays a significant role in the design, development, and commercialization of new medical technologies. A comprehensive understanding of the various regulatory requirements and their practical implementation is thus an essential cornerstone of successful medical device innovation. In this paper, we review the background, mission, and statutory requirements of medical device regulation in the United States. As opposed to pharmaceuticals, which have been regulated since the early 1900s, medical device regulation was not enacted before 1976, when Congress signed into law the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act of 1938. The U.S. Food and Drug Administration (FDA) has implemented a risk-based classification system, which is essential in determining the regulatory pathway for a given device. Our review of the different regulatory pathways discusses the specific steps and requirements associated with each pathway, and their implications for development and testing of different types of devices. The differences in these pathways are significant, and thus require careful consideration and analysis already at early stages of development. The FDA’s Quality Systems Regulation, which outlines specific requirements for development, testing, production, and postmarket surveillance, is another important aspect of device regulation. We present its elements and relationship to design controls and other operating procedures implemented by device manufacturers, and discuss their relevance in ensuring the safety and effectiveness of marketed devices. A summary of recent additions to device regulation, implemented by the FDA to allow for adequate regulation of products that combine drugs and devices or biologics and devices (so-called combination products), completes our review. Because of the significance of device regulation for medical device innovation, we strongly support increased efforts to educate the various stakeholders involved in the medical device development process, both at the academic and professional level.

Issue Section:
Technology Review
Keywords:
biomedical equipment, quality control, regulation, reviews, risk analysis
Topics:
Food and Drug Administration, Frequency-domain analysis, Medical devices, Safety, Risk, Design, Drugs
1.
Fries
,
R.
, 2006,
Reliable Design of Medical Devices
, 2nd ed.,
CRC
,
Boca Raton, FL
.
2.
FDA
, 2006, “
Is the Product a Medical Device?
,” FDA CDRH Web Publication, http://www.fda.gov/cdrh/devadvice/312.html#link_2http://www.fda.gov/cdrh/devadvice/312.html#link_2
3.
Fries
,
R.
, 1998,
Medical Device Quality Assurance and Regulatory Compliance
,
CRC
,
Boca Raton, FL
.
4.
FDA
, 2006, “
Device Advice—Device Classes
,” FDA CDRH Web Publication, http://www.fda.gov/cdrh/devadvice/3132.htmlhttp://www.fda.gov/cdrh/devadvice/3132.html, accessed Nov. 2006.
5.
FDA
, 2006, “
Medical Device Classification Procedure, Reclassification
,” Code of Federal Regulation, 21 CFR 860.130, Revised Apr. 1, 2006.
6.
FDA
, 2006, “
Medical Device Classification Procedures, Determination of Safety and Effectiveness
,” Code of Federal Regulation, 21 CFR 860.7, Revised Apr. 1, 2006.
7.
FDA
, 2006, “
Premarket Notification 510(k)
,” FDA CDRH Web Publication, http://www.fda.gov/cdrh/devadvice/314.htmlhttp://www.fda.gov/cdrh/devadvice/314.html, accessed Nov. 2006.
8.
FDA
, 2006, “
Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
,” Code of Federal Regulation, 21 CFR 807, Revised Apr. 1, 2006.
9.
FDA
, 2006, “
Premarket Approval of Medical Devices
,” Code of Federal Regulation, 21 CFR 814, Revised Apr. 1, 2006.
11.
FDA
, 2006, “
Premarket Approval of Medical Devices. Sec. s814.39 PMA Supplements
,” Code of Federal Regulation, 21 CFR 814.39, Revised Apr. 1, 2006.
13.
FDA
, 2006, “
Investigational Device Exemptions
,” Code of Federal Regulation, 21 CFR 812, Revised Apr. 1, 2006.
14.
FDA
, 2006, “
Quality System Regulation
,” Code of Federal Regulation, 21 CFR 820, Revised Apr. 1, 2006.
15.
FDA
, 2006, “
Quality System Regulation, Design Controls
,” Code of Federal Regulation, 21 CFR 820.30 and Sub-Clause 4.4 of ISO 9001.
16.
Kim
,
P.
, 2005, “
Trends in Postmarket Surveillance
,” MassMEDIC FDA Update, Dec. 9, 2005.
18.
Mehran
,
R.
,
Leon
,
M. B.
,
Feigal
,
D. A.
,
Jefferys
,
D.
,
Simons
,
M.
,
Chronas
,
N.
,
Fogarty
,
T. J.
,
Kuntz
,
R. E.
,
Baim
,
D. S.
, and
Kaplan
,
A. V.
, 2004, “
Post-Market Approval Surveillance: A Call for a More Integrated and Comprehensive Approach
,”
Circulation
0009-7322,
109
, pp.
3073
–
3077
.
Crossref
Search ADS
PubMed
 
19.
FDA
, 2006, “
Medical Device Postmarket Transformation Initiative
,” FDA CDRH Web Publication: http://www.fda.gov/cdrh/postmarket/mdpi.htmlhttp://www.fda.gov/cdrh/postmarket/mdpi.html
20.
Schultz
,
D.
, 2006, “
Ensuring the Safety of Marketed Medical Devices
,”
FDA CDRH Presentation
, Jan. 4.
21.
FDA
, 2006, “
Actions and Reports With a Due Date Specified by the Medical Device User Fee and Modernization Act of 2002 and the Medical Devices Technical Corrections Act
,” FDA CDRH Web Publication: http://www.fda. gov.cdrh/mdufma/actiondates1.htmlhttp://www.fda. gov.cdrh/mdufma/actiondates1.html
22.
Schultz
,
D.
, 2006, “
Ensuring the Safety of Marketed Medical Devices
,”
FDA/AdvaMed Postmarket Workshop
, Feb. 8.
23.
FDA
, 2006, “
Definition of a Combination Product
,” Code of Federal Regulation, 21 CFR 3.2(e).
24.
U.S. Department of Health and Human Services, FDA CDRH:
“
Office of Device Evaluation—Annual Report, Fiscal Year 2004
,” http://www.fda.gov/cdrh/annual/fy2004/ode/2004.pdfhttp://www.fda.gov/cdrh/annual/fy2004/ode/2004.pdf
25.
FDA
, 2006, “
Office of Combination Products
,” FDA CDRH Web Publication, http://www.fda.gov/oc/combination/http://www.fda.gov/oc/combination/
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 by American Society of Mechanical Engineers
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