Laboratory-Developed Tests: Why does FDA think they Can Regulate them, and why do Others think they Cannot

This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.

Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details

FDA's Medical Device Clinical Trials Program

The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Such knowledge might be required to enable the development of user instructions, better understanding of limitations, evidence of clinical usefulness, or elements of product design that require additional changes.

Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details

Laboratory-Developed Tests: Why does FDA think they can Regulate them, and why do others think they Cannot

This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.

Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details

Laboratory-Developed Tests: Why does FDA Think They Can Regulate Them, and Why Do Others Think They Cannot

This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.

Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details

The Role of FDA in Health Care Software Regulations and Development

This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device.

Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details

Laboratory-Developed Tests: Why does FDA think They Can Regulate Them, and Why Do Others Think They Cannot

This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.

Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details

FDA's Medical Device Clinical Trials Program

The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Such knowledge might be required to enable the development of user instructions, better understanding of limitations, evidence of clinical usefulness, or elements of product design that require additional changes.

Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details

Laboratory-Developed Tests: Why does FDA think They Can Regulate Them, and Why Do Others Think They Cannot

This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.

Speaker: Anna Longwell | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details

The Role of FDA in Health Care Software Regulations and Development

This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device.

Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details

A second look at 510(k) changes

The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k).

Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details

FDA's Medical Device Clinical Trials Program

The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Such knowledge might be required to enable the development of user instructions, better understanding of limitations, evidence of clinical usefulness, or elements of product design that require additional changes.

Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details

Laboratory-Developed Tests: Why does FDA think They Can Regulate Them, and Why Do Others Think They Cannot

This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.

Speaker: Anna Longwell | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details

Laboratory-Developed Tests: Why does FDA think They Can Regulate Them, and Why Do Others Think They Cannot

This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.

Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details

FDA's Medical Device Clinical Trials Program

The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Such knowledge might be required to enable the development of user instructions, better understanding of limitations, evidence of clinical usefulness, or elements of product design that require additional changes.

Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details

A second look at 510(k) changes

The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k).

Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details

The Role of FDA in Health Care Software Regulations and Development

This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device

Speaker: Anna Longwell | View Anytime | Price: $190.00 | View Details

A second look at 510(k) changes

The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k).

Speaker: Anna Longwell | View Anytime | Price: $189.00 | View Details