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J Acupunct Res > Volume 32(4); 2015 > Article
Oh, Choi, Jo, Jung, Cho, Lee, Kim, and Kim: The registration and approval of Oriental Medical devices for the entry into U.S. market※
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Abstract

Objectives:

The Oriental medical device industry is expected to continue to experience significant growth. It should increase its global market share rather than focusing on the domestic market. Countries around the world self-regulate their domestic market, so this study aims to aid in the development of a particular overseas market by introducing the U.S.(the largest market) medical device registration and approval process.

Methods:

For an understanding of the US medical device licensing process, we researched the relevant regulatory organization (FDA), the history, definition and classification of medical devices, the approval and 510(k) submission process related to substantial equivalence, IEC 60601-1 Edition 3, usability tests, and so on.

Results:

Medical devices in the United States are assigned to one of three regulatory classes: Class I, Class II, and Class III, based on the level of control necessary to assure the safety and effectiveness of the device.
If a company’s device is classified as Class II and if it is not exempt, a 510k will be required for marketing
  1. A 510(k) is a premarket submission made to the FDA to demonstrate that the new device to be marketed is “substantially equivalent” to a legally marketed device (predicate device)

  2. The IEC 60601-1 Edition 3 preparation process, which contains information related to usability, is expensive and time-consuming but a critical requirement.

Conclusions:

Although the U.S. market has high barriers to entry, access to this, large overseas market will encourage development of the Oriental medical device industry and commercial value enhancement is expected.

Fig. 1
510(k) Decision-Making Flowchart
acup-32-4-91f1.gif
Fig. 2
Timeline of Communication during 510(k) Review
acup-32-4-91f2.gif
Fig. 3
Recognized Consensus Standards-IEC 60601-1:2012
acup-32-4-91f3.gif
Table 1
Medical specialty “panels”
Medical Specialty Regulation Citation (21CFR)
73 Anesthesiology Part 868
74 Cardiovascular Part 870
75 Chemistry Part 862
76 Dental Part 872
77 Ear, Nose, and Throat Part 874
78 Gastroenterology and Urology Part 876
79 General and Plastic Surgery Part 878
80 General Hospital Part 880
81 Hematology Part 864
82 Immunology Part 866
83 Microbiology Part 866
84 Neurology Part 882
85 Obstetrical and Gynecological Part 884
86 Ophthalmic Part 886
87 Orthopedic Part 888
88 Pathology Part 864
89 Physical Medicine Part 890
90 Radiology Part 892
91 Toxicology Part 862
Table 2
510(k) Forms
1 Medical Device User Fee Cover Sheet (Form FDA 3601)
2 CDRH Premarket Review Submission Cover Sheet
3 510(k) Cover Letter 510(k)
4 Indications for Use Statement
5 510(k) Summary or 510(k) Statement 510(k)
6 Truthful and Accuracy Statement
7 Class III Summary and Certification
8 Financial Certification or Disclosure Statement
9 Declarations of Conformity and Summary Reports
10 Executive Summary
11 Device Description
12 Substantial Equivalence Discussion
13 Proposed Labeling
14 Sterilization and Shelf Life
15 Biocompatibility
16 Software
17 Electromagnetic Compatibility and Electrical Safety
18 Performance Testing-Bench
19 Performance Testing-Animal
20 Performance Testing-Clinical
21 Other
Table 3
Sample size consideration (Faulkner, 2003)
No. users Min. % Found Mean % Found SD SE
5 55 85.55 9.2957 .9295
10 82 94.69 3.2187 .3218
15 90 97.05 2.1207 .2121
20 95 98.4 1.608 .1608
30 97 99 1.1343 .1051
V.
V.

References

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10. United States Code. 21 USC 321: Definitions; generally. [Internet]. Available from: URL: http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321&num=0&edition=prelim.

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16. U.S. FDA. The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications. [Internet]. Available from: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284443.pdf.

19. U.S. FDA. 510(k) Premarket Notification. [Internet]. Available from: URL: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm.

20. U.S. FDA. Recognized Consensus Standards. [Internet]. Available from: URL: http://www.fda.gov/medicaldevices/deviceregulationandguidance/standards/default.htm.

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