239
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
19
16
20
17
21
18
22
Global Medical Device Regulatory Strategy
35. Cardiovascular implants—Cardiac Valve Prostheses.
ANSI/AAMI/ISO 5840:2005/(R)2010. ANSI
website. http://webstore.ansi.org/RecordDetail.as-
px?sku=ANSI%2FAAMI%2FISO+5840%3A2005+
(R2010). Accessed 13 July 2020.
36. Requests for Feedback on Medical Device
Submissions: The Pre-Submission Program and
Meetings with Food and Drug Administration
Staff: Guidance for Industry and Food and Drug
Administration Staff. FDA website. http://
www.fda.gov/downloads/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/
UCM311176.pdf. Accessed 13 July 2020.
37. Use of International Standard ISO-10993, “Biological
Evaluation of Medical Devices Part 1: Evaluation and
Testing.” Final document issued 16 June 2016. FDA
website. https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/use-internation-
al-standard-iso-10993-1-biological-evaluation-med-
ical-devices-part-1-evaluation-and. Accessed 13 July
2020.
38. ISO 5840-3:2013—Cardiac valve prostheses—Part
3: Heart valve substitutes implanted by transcatheter
techniques. ISO website. http://www.iso.org/iso/
catalogue_detail.htm?csnumber=51313. Accessed 13
July 2020.
39. ISO 10555-4:1996—Sterile, single-use intravascular
catheters—Part 4: Balloon dilatation catheters. ISO
website. http://www.iso.org/iso/catalogue_detail.
htm?csnumber=19056. Accessed 13 July 2020.
40. ISO 25539-2:2008—Cardiovascular implants—
Endovascular devices—Part 2: Vascular stents. ISO
website. http://www.iso.org/iso/iso_catalogue/cata-
logue_ics/catalogue_detail_ics.htm?csnumber=35887.
Accessed 13 July 2020.
41. “FDA Insights: The ISO Standard for Endovascular
Grafts.” EndoVascular Today website. http://evtoday.
com/2003/08/0703_131.html/. Accessed 13 July 2020.
42. “Magnetic Needle Tackles Suturing in Challenging
Surgical Fields.” Boston Children’s Hospital website.
http://vector.childrenshospital.org/2014/10/mag-
netic-needle-tackles-suturing-in-challenging-surgi-
cal-fields/. Accessed 13 July 2020.
43. Is a new 510(k) required for a modification to
the device? FDA website. https://www.fda.gov/
medical-devices/premarket-notification-510k/
new-510k-required-modification-device. Accessed 16
July 2020.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
19
16
20
17
21
18
22
Global Medical Device Regulatory Strategy
35. Cardiovascular implants—Cardiac Valve Prostheses.
ANSI/AAMI/ISO 5840:2005/(R)2010. ANSI
website. http://webstore.ansi.org/RecordDetail.as-
px?sku=ANSI%2FAAMI%2FISO+5840%3A2005+
(R2010). Accessed 13 July 2020.
36. Requests for Feedback on Medical Device
Submissions: The Pre-Submission Program and
Meetings with Food and Drug Administration
Staff: Guidance for Industry and Food and Drug
Administration Staff. FDA website. http://
www.fda.gov/downloads/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/
UCM311176.pdf. Accessed 13 July 2020.
37. Use of International Standard ISO-10993, “Biological
Evaluation of Medical Devices Part 1: Evaluation and
Testing.” Final document issued 16 June 2016. FDA
website. https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/use-internation-
al-standard-iso-10993-1-biological-evaluation-med-
ical-devices-part-1-evaluation-and. Accessed 13 July
2020.
38. ISO 5840-3:2013—Cardiac valve prostheses—Part
3: Heart valve substitutes implanted by transcatheter
techniques. ISO website. http://www.iso.org/iso/
catalogue_detail.htm?csnumber=51313. Accessed 13
July 2020.
39. ISO 10555-4:1996—Sterile, single-use intravascular
catheters—Part 4: Balloon dilatation catheters. ISO
website. http://www.iso.org/iso/catalogue_detail.
htm?csnumber=19056. Accessed 13 July 2020.
40. ISO 25539-2:2008—Cardiovascular implants—
Endovascular devices—Part 2: Vascular stents. ISO
website. http://www.iso.org/iso/iso_catalogue/cata-
logue_ics/catalogue_detail_ics.htm?csnumber=35887.
Accessed 13 July 2020.
41. “FDA Insights: The ISO Standard for Endovascular
Grafts.” EndoVascular Today website. http://evtoday.
com/2003/08/0703_131.html/. Accessed 13 July 2020.
42. “Magnetic Needle Tackles Suturing in Challenging
Surgical Fields.” Boston Children’s Hospital website.
http://vector.childrenshospital.org/2014/10/mag-
netic-needle-tackles-suturing-in-challenging-surgi-
cal-fields/. Accessed 13 July 2020.
43. Is a new 510(k) required for a modification to
the device? FDA website. https://www.fda.gov/
medical-devices/premarket-notification-510k/
new-510k-required-modification-device. Accessed 16
July 2020.