Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices – Draft Guidance for Industry and Food and Drug Administration Staff – FDA – 20 June 2014

Posted on June 23, 2014. Filed under: Health Informatics, Health Technology Assessment | Tags: |

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices – Draft Guidance for Industry and Food and Drug Administration Staff – FDA – 20 June 2014

Commentary on the guidance: FDA Encourages Medical Device Data System Innovation – FDA Blog – 20 June 2014

“Thanks to advances in digital health, doctors and their patients are more frequently using computer systems to collect medical data that can provide useful information on a patient’s health.

Some of these systems, referred to as “medical device data systems,” are off-the-shelf or custom hardware or software products that transfer, store, convert format, and display medical device data without modifying it, and without controlling or altering the functions or parameters of any connected medical devices.

Medical device data systems can collect and store data from a variety of other medical devices, including glucose meters, blood pressure cuffs, and weight scales. This data can be used at home to track certain information or it can be stored for a doctor to review at a later time.

Medical device data systems can be used in hospitals to collect information and data from other medical devices including bedside monitors and infusion pumps. This information can then be stored in a patient’s electronic health record for a more complete review of a patient’s total health.

In 2011, FDA issued a regulation down-classifying medical device data systems. Since that time, FDA has gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public.

Today, given the low level of patient risk, we are proposing a compliance policy under which medical device data systems should see their burdens reduced.

Why would we do that?”

… continues on the site

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FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework – April 2014

Posted on April 7, 2014. Filed under: Health Informatics | Tags: , |

 

FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework – April 2014

 

Proposed Strategy and Recommendations for a Risk-Based Framework

 

“Health information technology (HIT) presents tremendous benefits to the American public, including greater prevention of medical errors, improved efficiency and health care quality, reduced costs, and increased consumer engagement However, if HIT is not designed, developed, implemented, maintained, or used properly, it can pose risks to patients.

 

Federal law passed by U.S. Congress in 2012 requires that the Food and Drug Administration (FDA), in consultation with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC) develop and post on their respective web sites “a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.”  This report fulfills that requirement.

 

The FDA, ONC, and FCC seek public comment on whether the focus areas identified in the report are the appropriate ones, and whether the proposed next steps will lead to an environment where patient safety is protected, innovation is promoted, and regulatory duplication is avoided.

 

The three agencies sought and collected public comment in a collaborative and transparent manner, which is reflected in the draft framework. Much of the draft framework is based on recommendations from the public, industry, a 2011 Institute of Medicine report on HIT and Patient Safety, and input from the FDASIA Working Group.

 

There are some areas of health IT oversight that will benefit from continued engagement, including clinical decision support IT and electronic health records. For that reason, the FDA is opening a docket to accept comments on the report. A link will be provided as soon as it is available. In the coming weeks the FDA will announce dates for a 3-day public meeting to discuss the report.”

 

Media release: Proposed health IT strategy aims to promote innovation, protect patients, and avoid regulatory duplication

 

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Guidance for Industry: Electronic Source Data in Clinical Investigations – FDA – September 2013

Posted on September 26, 2013. Filed under: Research | Tags: |

Guidance for Industry: Electronic Source Data in Clinical Investigations – FDA – September 2013

“This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations.

In an effort to streamline and modernize clinical investigations this guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.”

… continues on the site

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Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff – FDA – 25 September 2013

Posted on September 25, 2013. Filed under: Health Informatics | Tags: , , , |

Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff – FDA – 25 September 2013

Extract from the introduction:

“The Food and Drug Administration (FDA) recognizes the extensive variety of actual and potential functions of mobile apps, the rapid pace of innovation in mobile apps, and the potential benefits and risks to public health represented by these apps. The FDA is issuing this guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or “mobile apps”). Given the rapid expansion and broad applicability of mobile apps, the FDA is issuing this guidance document to clarify the subset of mobile apps to which the FDA intends to apply its authority.

Many mobile apps are not medical devices (meaning such mobile apps do not meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), and FDA does not regulate them. Some mobile apps may meet the definition of a medical device but because they pose a lower risk to the public, FDA intends to exercise enforcement discretion over these devices (meaning it will not enforce requirements under the FD&C Act). The majority of mobile apps on the market at this time fit into these two categories.

Consistent with the FDA’s existing oversight approach that considers functionality rather than platform, the FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended. This subset of mobile apps the FDA refers to as mobile medical apps.

FDA is issuing this guidance to provide clarity and predictability for manufacturers of mobile medical apps.”

… continues

Commentary on this:

FDA outlines rules for medical apps on phones, tablets – The Hill – 23 September 2013

FDA Updates Guidance on Mobile-Software Apps – The Wall Street Journal – 23 September 2013

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U.S. FDA issues final rule on medical device identifier codes – Reuters – 20 September 2013

Posted on September 24, 2013. Filed under: Health Technology Assessment | Tags: , , , |

U.S. FDA issues final rule on medical device identifier codes – Reuters – 20 September 2013

“The U.S. Food and Drug Administration issued a long-awaited rule on Friday requiring companies to include codes on medical devices that will allow regulators to track the products, monitor them for safety and expedite recalls.

The codes, known as unique device identifiers, or UDIs, will be entered into a database that the agency will maintain as a publicly searchable reference catalogue.

… continues on the site

(Reporting by Toni Clarke in Washington; Editing by John Wallace, David Gregorio and Sofina Mirza-Reid)”

FDA Rule

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FDA proposes unique device identification system for medical devices – 3 July 2012

Posted on July 4, 2012. Filed under: Health Technology Assessment | Tags: , |

FDA proposes unique device identification system for medical devices – 3 July 2012

“Today, in response to requirements in legislation that passed Congress with broad bipartisan support, the U.S. Food and Drug Administration proposed that most medical devices distributed in the United States carry a unique device identifier, or UDI.

A UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups and conducted four pilot studies in the development of this proposed rule. The FDA is seeking comment on the proposal for 120 days.”

… continues

For more information:

Proposed Rule: Unique Device Identification System

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Antibiotics. FDA Needs to Do More to Ensure That Drug Labels Contain Up-to-Date Information – GAO – January 2012

Posted on February 2, 2012. Filed under: Pharmacy | Tags: , , |

Antibiotics. FDA Needs to Do More to Ensure That Drug Labels Contain Up-to-Date Information – GAO – January 2012

“What GAO Found

FDA has not taken sufficient steps to ensure that antibiotic labels contain up-to-date breakpoints. FDA designates certain drugs as “reference-listed drugs” and the sponsors of these drugs play an important role in ensuring the accuracy of drug labels. Reference-listed drugs are approved drug products to which generic versions are compared. As of November 2011, FDA had not yet confirmed whether the breakpoints on the majority of reference-listed antibiotics labels were up to date. FDA contacted sponsors of 210 antibiotics in early 2008 to remind sponsors of the importance of maintaining their labels and requested that they assess whether the breakpoints on their drugs’ labels were up to date. Sponsors were asked to submit evidence to FDA showing that the breakpoints were either current or needed revision. As of November 2011, over 3.5 years after FDA contacted sponsors, the agency had not yet confirmed whether the breakpoints on the labels of 70 percent, or 146 of the 210 antibiotics, were up to date.”  … continues

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Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years – 29 July 2011

Posted on August 1, 2011. Filed under: Health Technology Assessment | Tags: , |

Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years – 29 July 2011

Full text

“Medical devices play a critical role in the health care of Americans. They can range from simple tools, such as tongue depressors and bandages, to complex or life-saving equipment, such as pacemakers, magnetic resonance imaging machines, and heart–lung machines. The Federal Food, Drug, and Cosmetic Act (FFDCA) requires a “reasonable assurance of safety and effectiveness” before a device can be marketed, and the U.S. Food and Drug Administration (FDA) is responsible for enforcing this requirement. Devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the 510(k) process, named for Section 510(k) of the FFDCA.  Some policymakers and patients have expressed concern about the ability of the 510(k) process to ensure that medical devices on the market are safe and effective. Other policymakers and patients, as well as the medical-device industry, have asserted that the process has become too burdensome and time-consuming and that it is delaying important new medical devices from entering the market.

The FDA turned to the IOM to review the 510(k) process and answer two questions:

Does the current 510(k) process protect patients optimally and promote innovation in support of public health?
If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process optimally
The IOM finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle. The IOM outlines its criteria for this framework in the report.”

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Mobile medical applications – draft guidance – FDA – 21 July 2011

Posted on July 20, 2011. Filed under: Health Informatics, Health Technology Assessment | Tags: |

Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications – 21 July 2011

This guidance document is being distributed for comment purposes only.

Extract from the introduction

“The Food and Drug Administration (FDA) is issuing this draft guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or “mobile apps”).

Given the rapid expansion and broad applicability of mobile apps, the FDA is issuing this draft guidance document to clarify the types of mobile apps to which the FDA intends to apply its authority. At this time, the FDA intends to apply its regulatory requirements solely to a subset of mobile apps that it is calling mobile medical applications or “mobile medical apps.” ”  … continues

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