Streamlining the Regulatory Path to Market for Low-Risk Med Devices | Page 8

REFERENCES
IMPORTANT FDA WEBSITES FOR—
Finding out if a device is exempt from
FDA review
http:/
/www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfpcd/315.cfm
Registering an organization with the FDA
http:/
/www.access.fda.gov/oaa/logonFlow

Identifying a predicate device
http:/
/www.accessdata.fda.gov/scrIpts/cdrh/
cfdocs/cfPMN/pmn.cfm
Finding FDA-recognized consensus standards
http:/
/www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.

Finding out the Class of a device
http:/
/www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfpcd/classification.cfm

1. Holtzman Y. The U.S. Medical Device Industry in
2012: Challenges at Home and Abroad. Medical Device
and Diagnostic Industry. Available at: http://www.
mddionline.com/article/medtech-2012-SWOT.
Accessed November 17, 2014.
2. U.S. Food and Drug Administration.
Regulatory Information. Available at: http://www.
fda.gov/RegulatoryInformation/Legislation/
FederalFoodDrugandCosmeticActFDCAct/
FDCActChaptersIandIIShortTitleandDefinitions/
ucm086297.htm. Accessed November 25, 2014.
3. U.S. Food and Drug Administration. Overview of
Device Regulation. Available at: http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/
Overview/. Accessed November 25, 2014.
4. Mathewson NW. Prohibited Acts and Enforcement
Tools. Food and Drug Law Journal. Available at:
http://www.ofwlaw.com/CM/Articles/Nancy%20
Mathewson%20FDLI%20Article%20-%20Prohitibet%20
Acts%20and%20Enforcement%20Tools.pdf. Accessed
December 8, 2014.
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5. Praxiom Research Group Limited. ISO 14971 2007,
Plain English Dictionary. Available at: http://www.
praxiom.com/iso-14971-terms.htm. Accessed
December 8, 2014.
6. U.S. Food and Drug Administration. Classify Your
Medical Device. Available at: http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/
Overview/ClassifyYourDevice/. Accessed
December 8, 2014.
7. U.S. Food and Drug Administration. FDA Industry
Systems. Available at: https://www.access.fda.gov/oaa/
logonFlow.
8. Emergo. How long does it take for a 510(k) submission
to be cleared by the U.S. FDA? Available at: http://www.
emergogroup.com/resources/research/fda-510k-reviewtimes-research. Accessed December 8, 2014.
9. Syring G. Overview: FDA Regulation of Medical
Devices. Available at: http://www.qrasupport.com/
FDA_MED_DEVICE.html. Accessed December 8, 2014.

AUTHOR BIO
Charlotte Baker, RAC, PMP
Senior Director, Regulatory & Strategic Development,
Medical Devices, Clinipace Worldwide
Charlotte brings more than 20 years experience in regulatory, quality and compliance
in the healthcare, biopharma and medical device industries. She also has a proven
track record in leading and achieving successful global product submissions/approvals
for new products and post-commercialization changes (PMA & 510k). In her current
role, Charlotte is responsible for developing regulatory strategies for client products.
She also prepares regulatory submissions for the US FDA, EMEA and other
regulatory authorities.

To watch the companion webcast to this ebook, visit
go.clinipace.com/LowRiskMedicalDeviceWebcast_register.html

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