1. Date of download: 10/20/2017
Copyright © ASME. All rights reserved.
From: Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience
J. Med. Devices. 2012;6(2): doi: /
Figure Legend:
Importance of regulatory requirements for business decision about major investment in a new product

2. Date of download: 10/20/2017
Copyright © ASME. All rights reserved.
From: Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience
J. Med. Devices. 2012;6(2): doi: /
Figure Legend:
Importance of predictability of the regulatory process in deciding about first country for market launch

3. Date of download: 10/20/2017
Copyright © ASME. All rights reserved.
From: Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience
J. Med. Devices. 2012;6(2): doi: /
Figure Legend:
Role of device-specific guidance documents: percentage of not substantially equivalent or withdrawn submissions with and without existing guidance documents (left), versus the percentage of substantially equivalent submissions with and without existing guidance documents (right)

4. Date of download: 10/20/2017
Copyright © ASME. All rights reserved.
From: Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience
J. Med. Devices. 2012;6(2): doi: /
Figure Legend:
Breakdown of FDA requests for additional information, as reported by respondents

5. Date of download: 10/20/2017
Copyright © ASME. All rights reserved.
From: Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience
J. Med. Devices. 2012;6(2): doi: /
Figure Legend:
Respondents’ interpretation of the nature of FDA questions or requests for information received during a 510(k) review