USA Archives - Page 6 of 7

USA – Independent assessment of the NESTcc Test-Cases: RAND Interim Report Provides Insights from RWE Generation for Medical Devices
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USA – Independent assessment of the NESTcc Test-Cases: RAND Interim Report Provides Insights from RWE Generation for Medical Devices

2022, January 2022, Medical Devices, Members-Only, Minor Update, RWD to Support Reg Decisions, USA

USA – Independent assessment of the NESTcc Test-Cases: RAND Interim Report Provides Insights from RWE Generation for Medical Devices

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USA – Independent assessment of the NESTcc Test-Cases: RAND Interim Report Provides Insights from RWE Generation for Medical Devicesstuart.mccully2022-08-07T16:50:26+00:00

USA – NESTcc publishes Data Quality Maturity Model Self-Assessment Tools to complement initial Data Quality Framework
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USA – NESTcc publishes Data Quality Maturity Model Self-Assessment Tools to complement initial Data Quality Framework

2022, January 2022, Medical Devices, Members-Only, Minor Update, USA

USA – NESTcc publishes Data Quality Maturity Model Self-Assessment Tools to complement initial Data Quality Framework

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USA – NESTcc publishes Data Quality Maturity Model Self-Assessment Tools to complement initial Data Quality Frameworkstuart.mccully2022-08-07T16:51:09+00:00

USA – FDA Finalises Guidance on Principles for Selecting, Developing, Modifying, and Adapting PRO Instruments for Use in Medical Device Evaluation
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USA – FDA Finalises Guidance on Principles for Selecting, Developing, Modifying, and Adapting PRO Instruments for Use in Medical Device Evaluation

2022, January 2022, Medical Devices, Members-Only, Moderate Update, USA

USA – FDA Finalises Guidance on Principles for Selecting, Developing, Modifying, and Adapting PRO Instruments for Use in Medical Device Evaluation

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USA – FDA Finalises Guidance on Principles for Selecting, Developing, Modifying, and Adapting PRO Instruments for Use in Medical Device Evaluationstuart.mccully2022-08-07T16:54:16+00:00

USA | Draft FDA Guidance on the Correct Definition of a ‘Device’
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USA | Draft FDA Guidance on the Correct Definition of a ‘Device’

2021, December 2021, Medical Devices, Members-Only, Minor Update, USA

USA | Draft FDA Guidance on the Correct Definition of a ‘Device’

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USA | Draft FDA Guidance on the Correct Definition of a ‘Device’stuart.mccully2022-08-07T16:56:09+00:00

USA | Draft FDA Guidance: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
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USA | Draft FDA Guidance: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

2021, December 2021, Digital Health, Members-Only, Moderate Update, USA

USA | Draft FDA Guidance: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

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USA | Draft FDA Guidance: Digital Health Technologies for Remote Data Acquisition in Clinical Investigationsstuart.mccully2022-08-07T16:56:55+00:00

USA | Draft FDA Guidance: Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products
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USA | Draft FDA Guidance: Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products

2021, December 2021, Members-Only, Moderate Update, RWD to Support Reg Decisions, USA

USA | Draft FDA Guidance: Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products

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USA | Draft FDA Guidance: Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products stuart.mccully2022-08-07T16:57:47+00:00

USA | Draft FDA Guidance on Registries
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USA | Draft FDA Guidance on Registries

2021, Members-Only, Moderate Update, November 2021, RWD to Support Reg Decisions, USA

USA | Draft FDA Guidance on Registries

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USA | Draft FDA Guidance on Registriesstuart.mccully2022-08-07T17:02:54+00:00

USA – The FDA Launches its First FDA Video Focused on Patient Cybersecurity Best Practices
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USA – The FDA Launches its First FDA Video Focused on Patient Cybersecurity Best Practices

2021, Medical Devices, Members-Only, Minor Update, October 2021, USA

USA – The FDA Launches its First FDA Video Focused on Patient Cybersecurity Best Practices

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USA – The FDA Launches its First FDA Video Focused on Patient Cybersecurity Best Practicesstuart.mccully2022-08-07T17:07:01+00:00

USA – New FDA Draft Guidance for Industry: Data Standards for Drug and Biological Product Submissions Containing Real-World Data
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USA – New FDA Draft Guidance for Industry: Data Standards for Drug and Biological Product Submissions Containing Real-World Data

2021, Members-Only, Moderate Update, October 2021, RWD to Support Reg Decisions, USA

USA – New FDA Draft Guidance for Industry: Data Standards for Drug and Biological Product Submissions Containing Real-World Data

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USA – New FDA Draft Guidance for Industry: Data Standards for Drug and Biological Product Submissions Containing Real-World Datastuart.mccully2022-08-07T17:11:09+00:00

USA – New FDA Draft Guidance for Industry: Good Machine Learning Practice for Medical Device Development
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USA – New FDA Draft Guidance for Industry: Good Machine Learning Practice for Medical Device Development

2021, AI, Medical Devices, Members-Only, Moderate Update, October 2021, USA

USA – New FDA Draft Guidance for Industry: Good Machine Learning Practice for Medical Device Development

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USA – New FDA Draft Guidance for Industry: Good Machine Learning Practice for Medical Device Developmentstuart.mccully2022-08-07T17:12:00+00:00

USA – Independent assessment of the NESTcc Test-Cases: RAND Interim Report Provides Insights from RWE Generation for Medical Devices

USA – NESTcc publishes Data Quality Maturity Model Self-Assessment Tools to complement initial Data Quality Framework

USA – FDA Finalises Guidance on Principles for Selecting, Developing, Modifying, and Adapting PRO Instruments for Use in Medical Device Evaluation

USA | Draft FDA Guidance on the Correct Definition of a ‘Device’

USA | Draft FDA Guidance: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

USA | Draft FDA Guidance: Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products

USA | Draft FDA Guidance on Registries

USA – The FDA Launches its First FDA Video Focused on Patient Cybersecurity Best Practices

USA – New FDA Draft Guidance for Industry: Data Standards for Drug and Biological Product Submissions Containing Real-World Data

USA – New FDA Draft Guidance for Industry: Good Machine Learning Practice for Medical Device Development

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