236
Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy
Conclusion
Standards, by definition, are documents
established by consensus and approved by a
recognized body. Medical device standards pro-
vide for common and repeated use, guidelines
or characteristics for activities or their results,
aimed at achieving the optimal degree of order.
In the medical device global regulatory strategy
context, standards are considered “norms” in
some countries that must be followed during
the conformity assessment process to meet
regulatory Essential Requirements. Using stan-
dards confers a presumption of conformity with
mandatory regulatory requirements of these
countries. In other countries, standards, in the
context of meeting regulatory requirements, are
not standalone documents and must be applied
in parallel with local regulations. Generally,
standards developed by SDOs are voluntary
and should be utilized in consultation with local
laws and IMDRF guidelines.
Guidances, Resources and Standards
• AAMI ANSI HE75:2009(2013) Human Factors
Engineering—Design of Medical Devices. AAMI web-
site. https://my.aami.org/aamiresources/previewfiles/
he75_1311_preview.pdf. Accessed 13 July 2020.
• ASTM F 2516-07 Standard Test Method for Tension
Testing of Nickel-Titanium Superelastic Materials.
ASTM website. https://www.astm.org/DATABASE.
CART/HISTORICAL/F2516-07.htm. Accessed 13
July 2020.
• ASTM F 1980-07(2011) Standard Guide for
Accelerated Aging of Sterile Barrier Systems for Medical
Devices. ASTM website. https://www.astm.org/
DATABASE.CART/HISTORICAL/F1980-07R11.
htm. Accessed 13 July 2020.
• ASTM D 4169 Standard Practice for Performance
Testing of Shipping Containers and Systems. ASTM
website. https://www.astm.org/Standards/D4169.htm.
Accessed 13 July 2020.
• ASTM D 642-00 Standard Test Method for
Determining Compressive Resultant of Shipping
Containers, Components and Unit Loads. ASTM
website. http://materialstandard.com/wp-content/
uploads/2019/12/D642-15.pdf. Accessed 13 July
2020.
• The Brazil Good Manufacturing Practice (BGMP).
ANVISA website. http://portal.anvisa.gov.br/en/com-
panies. Accessed 13 July 2020.
• Medical Device Approvals in Brazil: A Review
and Update. Brazilian Resolution RDC 185/2001.
https://legacy-uploads.ul.com/wp-content/uploads/
sites/40/2015/02/UL_WP_Final_Medical-Device-
Approvals-in-Brazil_v7_HR.pdf. Accessed 13 July
2020.
• Clinical and Laboratory Standards Institute (CLSI)
Point-of-Care IVD Testing. https://clsi.org/. Accessed
13 July 2020.
• Appropriate Use of Voluntary Consensus Standards
in Premarket Submissions for Medical Devices:
Guidance for Industry and FDA Staff. FDA
website. https://www.fda.gov/regulatory-in-
formation/search-fda-guidance-documents/
appropriate-use-voluntary-consensus-standards-pre-
market-submissions-medical-devices. Accessed 14
July 2020.
• Guidance Document. The Content of Investigational
Device Exemption (IDE) and Premarket Approval
(PMA) Applications for Artificial Pancreas
Device Systems. Guidance for Industry and Food
and Drug Administration Staff. FDA website.
https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/content-investiga-
tional-device-exemption-ide-and-premarket-approv-
al-pma-applications-artificial. Accessed 13 July 2020.
• Guidance for Industry and Food and Drug
Administration Staff. FDA website. https://www.fda.
gov/media/71983/download. Accessed 13 July 2020.
• Guidance for Industry and Food and Drug
Administration Staff: Content of Premarket
Submissions for Management of Cybersecurity in
Medical Devices and Factors to Consider When Making
Benefit-Risk Determinations in Medical Device
Premarket Approval and De Novo Classifications.
FDA website. https://www.fda.gov/regulato-
ry-information/search-fda-guidance-documents/
content-premarket-submissions-management-cyber-
security-medical-devices. Accessed 13 July 2020.
• Final Guidance for Industry and the Food and
Drug Administration Staff: The Content of
Investigational Device Exemption (IDE) and
Premarket Approval (PMA) Applications for
Artificial Pancreas Device Systems. FDA website.
https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/content-investiga-
tional-device-exemption-ide-and-premarket-approv-
al-pma-applications-artificial. Accessed 13 July 2020.
• Medical Device User Fee Amendments
(MDUFA). FDA website. https://www.fda.gov/
industry/fda-user-fee-programs/medical-device-us-
er-fee-amendments-mdufa. Accessed 13 July 2020.
• IEC 60601-1-2 Electromagnetic Disturbances:
Requirements and Tests. IEC website. https://www.
iecee.org/dyn/www/f?p=106:49:0::::FSP_STD_
ID:2590. Accessed 13 July 2020.
• IEC 60601 Part 1-3: General Requirements for Basic
Safety and Essential Performance: Collateral Standard:
Radiation Protection in Diagnostic X-Ray Equipment.
https://webstore.iec.ch/publication/2592. Accessed 13
July 2020.
• IEC 62304 Medical Device Software—Software Life
Cycle Processes. https://webstore.iec.ch/preview/
info_iec62304%7Bed1.0%7Den_d.pdf. Accessed 13
July 2020.
• IEC TR 80002-1:2009—Medical Device Software—
Part 1: Guidance on the Application of ISO 14971 to
Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy
Conclusion
Standards, by definition, are documents
established by consensus and approved by a
recognized body. Medical device standards pro-
vide for common and repeated use, guidelines
or characteristics for activities or their results,
aimed at achieving the optimal degree of order.
In the medical device global regulatory strategy
context, standards are considered “norms” in
some countries that must be followed during
the conformity assessment process to meet
regulatory Essential Requirements. Using stan-
dards confers a presumption of conformity with
mandatory regulatory requirements of these
countries. In other countries, standards, in the
context of meeting regulatory requirements, are
not standalone documents and must be applied
in parallel with local regulations. Generally,
standards developed by SDOs are voluntary
and should be utilized in consultation with local
laws and IMDRF guidelines.
Guidances, Resources and Standards
• AAMI ANSI HE75:2009(2013) Human Factors
Engineering—Design of Medical Devices. AAMI web-
site. https://my.aami.org/aamiresources/previewfiles/
he75_1311_preview.pdf. Accessed 13 July 2020.
• ASTM F 2516-07 Standard Test Method for Tension
Testing of Nickel-Titanium Superelastic Materials.
ASTM website. https://www.astm.org/DATABASE.
CART/HISTORICAL/F2516-07.htm. Accessed 13
July 2020.
• ASTM F 1980-07(2011) Standard Guide for
Accelerated Aging of Sterile Barrier Systems for Medical
Devices. ASTM website. https://www.astm.org/
DATABASE.CART/HISTORICAL/F1980-07R11.
htm. Accessed 13 July 2020.
• ASTM D 4169 Standard Practice for Performance
Testing of Shipping Containers and Systems. ASTM
website. https://www.astm.org/Standards/D4169.htm.
Accessed 13 July 2020.
• ASTM D 642-00 Standard Test Method for
Determining Compressive Resultant of Shipping
Containers, Components and Unit Loads. ASTM
website. http://materialstandard.com/wp-content/
uploads/2019/12/D642-15.pdf. Accessed 13 July
2020.
• The Brazil Good Manufacturing Practice (BGMP).
ANVISA website. http://portal.anvisa.gov.br/en/com-
panies. Accessed 13 July 2020.
• Medical Device Approvals in Brazil: A Review
and Update. Brazilian Resolution RDC 185/2001.
https://legacy-uploads.ul.com/wp-content/uploads/
sites/40/2015/02/UL_WP_Final_Medical-Device-
Approvals-in-Brazil_v7_HR.pdf. Accessed 13 July
2020.
• Clinical and Laboratory Standards Institute (CLSI)
Point-of-Care IVD Testing. https://clsi.org/. Accessed
13 July 2020.
• Appropriate Use of Voluntary Consensus Standards
in Premarket Submissions for Medical Devices:
Guidance for Industry and FDA Staff. FDA
website. https://www.fda.gov/regulatory-in-
formation/search-fda-guidance-documents/
appropriate-use-voluntary-consensus-standards-pre-
market-submissions-medical-devices. Accessed 14
July 2020.
• Guidance Document. The Content of Investigational
Device Exemption (IDE) and Premarket Approval
(PMA) Applications for Artificial Pancreas
Device Systems. Guidance for Industry and Food
and Drug Administration Staff. FDA website.
https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/content-investiga-
tional-device-exemption-ide-and-premarket-approv-
al-pma-applications-artificial. Accessed 13 July 2020.
• Guidance for Industry and Food and Drug
Administration Staff. FDA website. https://www.fda.
gov/media/71983/download. Accessed 13 July 2020.
• Guidance for Industry and Food and Drug
Administration Staff: Content of Premarket
Submissions for Management of Cybersecurity in
Medical Devices and Factors to Consider When Making
Benefit-Risk Determinations in Medical Device
Premarket Approval and De Novo Classifications.
FDA website. https://www.fda.gov/regulato-
ry-information/search-fda-guidance-documents/
content-premarket-submissions-management-cyber-
security-medical-devices. Accessed 13 July 2020.
• Final Guidance for Industry and the Food and
Drug Administration Staff: The Content of
Investigational Device Exemption (IDE) and
Premarket Approval (PMA) Applications for
Artificial Pancreas Device Systems. FDA website.
https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/content-investiga-
tional-device-exemption-ide-and-premarket-approv-
al-pma-applications-artificial. Accessed 13 July 2020.
• Medical Device User Fee Amendments
(MDUFA). FDA website. https://www.fda.gov/
industry/fda-user-fee-programs/medical-device-us-
er-fee-amendments-mdufa. Accessed 13 July 2020.
• IEC 60601-1-2 Electromagnetic Disturbances:
Requirements and Tests. IEC website. https://www.
iecee.org/dyn/www/f?p=106:49:0::::FSP_STD_
ID:2590. Accessed 13 July 2020.
• IEC 60601 Part 1-3: General Requirements for Basic
Safety and Essential Performance: Collateral Standard:
Radiation Protection in Diagnostic X-Ray Equipment.
https://webstore.iec.ch/publication/2592. Accessed 13
July 2020.
• IEC 62304 Medical Device Software—Software Life
Cycle Processes. https://webstore.iec.ch/preview/
info_iec62304%7Bed1.0%7Den_d.pdf. Accessed 13
July 2020.
• IEC TR 80002-1:2009—Medical Device Software—
Part 1: Guidance on the Application of ISO 14971 to