FDA Guidance: FAQ for In Vitro Diagnostic Devices (IVDs)

September 27, 2010

FDA FAQ IVD

FDA Guidance: FAQ for
In Vitro Diagnostic
Medical Devices

In Vitro Diagnostic medical devices (IVDs) have long occupied a poorly understood sector of clinical trials. Now, a recent FDA document, Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies- Frequently Asked Questions (June 25, 2010) clears up many questions. The FAQ offers resources including the definition of many basic IVD and medical device terms. Examples include the FDA definition of the difference between Invasive and Non-Invasive and the difference between a Significant Risk and Non-Significant medical device. The FAQ gives FDA contact information for IVD review divisions and the conduct of clinical trials. Most importantly, the FAQ discusses how IVDs meet the criteria for exemption from most requirements under medical device clinical trial regulations.

The FAQ discusses the requirements for the emergency use of investigational IVDs. It also discusses the differences in informed consent requirements between FDA and the U.S. Department of Health and Human Services which funds NIH studies. Frequently researchers think that if a study is exempt under DHHS regulations (Title 45 Part 46) that the study is exempt from FDA informed consent regulations found in 21 CFR Parts 50 and 56. FDA requires IRB and informed consent even if studies are exempt from most requirements of 21 Part 812.

The FAQ also discusses use of data collected from studies conducted outside the United States. The FAQ gives the following guidance:

… the PMA regulation, 21 CFR Part 814, allows foreign data to be used as the sole support of a marketing application but only if (1) the data are applicable to the U.S. population and to U.S. medical practices, including laboratory practices, (2) the studies have been performed by clinical investigators of recognized competence, and (3) the data may be considered valid without the need for an on-site FDA inspection or, if necessary, FDA can validate the data through an on-site inspection or other appropriate means (21 CFR 814.15(d)).

For IVD devices, FDA would consider differences in population demographics, disease prevalence, disease presentation, laboratory practices, and medical standards of care. If the sponsor plans to submit an application based solely on foreign data, FDA recommends that the sponsor consult with the reviewing division prior to submission of the application.

FAQ FDA IVD

ICH Good Clinical Practice Can Also Apply to Medical Device Studies

The FAQ endorses ICH E6: Consolidated Guidance on Good Clinical Practice as a sound guidance document with sections applicable to medical devices as well as pharmaceuticals. It also discusses the draft ISO 14155 document:

Although the ICH document was written for studies of pharmaceuticals, sections of the guidance address study issues common to all investigational products. Thus, these sections of the ICH GCP provide a useful reference regarding the proper conduct of studies.

The draft ISO document specifically states that it does not apply to IVD devices. The draft ISO document is an international document intended to reflect basic practices appropriate to clinical trials worldwide. It does not include all of FDA’s specific requirements for clinical studies and is not presently a standard that FDA has officially recognized; therefore, we do not recommend that you rely on it.

IVD In Vitro FDA FAQ

Appendix 2 Shows Requirements for IRB Approval and Informed Consent

The FAQ has two charts, Appendix 1 and Appendix 2, that clear up decision making for IVD exeption criteria as well as informed consent requirements. And in keeping with current FDA clinical trial policy the FAQ emphasizes the use of quality systems for IVDs. The FAQ and two other relevant FDA guidance documents are below:

FAQs for In Vitro Diagnostic Devices

FDA Guidance on Informed Consent for IVDs Using Leftover Human Specimens

Comparison of FDA (21 CFR 50 & 56) and DHHS (45 CFR 46) Regulations

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UPDATE: My favorite industry magazine, Applied Clinical Trials, now has a LinkedIn Group:
Applied Clinical Trials LinkedIn
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++++In news from GxP Perspectives++++

Read the updated article on the Form FDA 1572 in:

Applied Clinical Trials “Closing Thought” on FDA 1572

ALSO: Please join me on LinkedIn at:

GxP Perspectives LinkedIn Group

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Top FDA, Health, and Science Blogs

September 8, 2010

FDA health science blogs

Hamlet and Yorick Discuss FDA Compliance, Health,
& Science Blogs

Here are some interesting blogs on the topics of FDA regulated industry, FDA regulations, health and science that regular readers of GxP Perspectives might enjoy while I am on vacation. Everyone should have a vacation now and then and I am going off for almost two weeks!

Acronym Required states they follow science and industry but don’t tell a lot about themselves. Interesting reading.

Applied Clinical Trials: Their blog is one of the best. Take their salary survey.

Chemistry Explained: A good site on a dry topic. Not an actual blog.

Compliance Zen: “Practical FDA compliance insights and intelligence.”

Diabetes Self Management Well organized and informative

Drug Health Supersite An eclectic mix.

Endocrine Today: “Clinical news on diabetes and endocrine disorders.”

Eye on FDA: Not my favorite but an important blog on FDA stuff.

FDA Law Blog: As described

FDA Matters: Feisty blog on FDA from Steven Grossman

GxP Lifeline: A Master Control Newsletter (commercial content and GxP news)

Medical Devices Today: From Elsevier (not feisty)

Partners in Health Blog: News about the health organization’s work in Haiti.

PharmaGossip: We all need a little gossip in our lives. This blog has the longest blogroll I have ever seen (almost). Blogs that everyone has heard of and that no one has heard of.

PharmTech Talk: Pharmaceutical Technology’s excellent blog.

Two Decades and Counting: A GxP professional’s blog that is well worth checking out.

WSJ Health Blog: A good blog from a newspaper that I don’t read.

FDA blog health science

Hamlet Should Have Taken More Vacations

On my return I hope to have a post on the new FDA Guidance: FAQ for IVDs. I also have several Guest Commentaries lined up on the TMF reference model, informed consent, and more! And as for Hamlet and Yorick, Hamlet never said that he knew him well. He did say that Yorick was, “a fellow of infinite jest, of most excellent fancy.” Sounds like a “to be” kind of guy. Unfortunately, the Hamlet of Ashland 2010 left a little to be desired. Oh well.

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Announcement: The 18th and 19th of January 2011 I will be at the conference for Developing CAPAs in the GCP Environment, Arlington, VA.


Avandia Causes Furor in UK

September 7, 2010

Furor in UK over Avandia

Furor in United Kingdom Over Avandia

An independent panel of experts has called for the diabetes drug Avandia to be pulled from the shelves in the UK according to the Medicines and Healthcare products Regulatory Agency (MHRA). However, MHRA is not taking action at this time stating that “would cause confustion” and that they are waiting for a decision by the European Medicines Agency. A furor has broke out among experts on why the drug was approved in the first place. The Guardian newspaper reports the following:

A BBC Panorama documentary broadcast tonight and a BMJ article published today question whether there has been a failure of the UK’s regulatory system. The BMJ article asks whether there was sufficient clinical evidence in the first place for the product to be licensed by the European Medicines Agency (EMA) in 2000.”

The EMA is due with an opinion later this month and GSK, the maker of Avandia, stated: “patient safety is our priority”.

Read The Guardian Article

Avandia has caused quite a furor in the United States as well. The drug’s future remains unclear. Read GxP Perspectives Coverage of
Avandia Advisory Committee Meetings

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Save The Date: On 4-5 November 2010 the Pacific Regional Chapter of the Society for Quality Assurance (PRCSQA) and the Organization of Regulatory and Clinical Associates (ORCA), a Pacific Northwest based organization, will co-sponsor a Fall Training on regulatory compliance topics in Seattle, WA.

The PRCSQA LinkedIn Group will update the agenda for the training. PRCSQA Fall Training workshops have traditionally been “at cost” and are an affordable training opportunity. The sessions will cover both GCPs and GLPs with speakers lined up on vendor management, quality systems, and GLP updates.

++++In news from GxP Perspectives++++

Read the updated article on the Form FDA 1572 in:

Applied Clinical Trials “Closing Thought” on FDA 1572

ALSO: Please join me on LinkedIn at:

GxP Perspectives LinkedIn Group

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FDA To Honor Dr. Frances Kelsey

September 2, 2010

FDA honors Dr. Kelsey

President Kennedy Honors Dr. Frances Kelsey for Her Role in Drug Safety

The U.S. FDA is set to honor Dr. Frances Kelsey, a former medical reviewer who helped start the modern era of clinical trials 50 years ago. Dr. Kelsey prevented the approval of thalidomide in the United States because of concerns about peripheral neuropathy and the lack of testing on the drug’s safety. Among the drug’s proposed usages included treating morning sickness during pregnancy. It was unknown at the time that the drug would pass the placental barrier between a pregnant woman and the fetus. In Europe there were thousands of “thalidomide babies” born with terrible birth defects, including phocomelia, that left the children with deformed limbs sometimes resembling a seal type flipper instead of an arm or leg. The tragedy led to the Kefauver-Harris Amendments to the Food Drug and Cosmetic Act and the requirement for “adequate and well controlled trials” along with testing for safety.

FDA Commissioner Dr. Margaret Hamburg announced that FDA would honor Dr. Kelsey’s achievements.

50 years ago a relatively junior medical reviewer, Dr. Frances O. Kelsey said no to an application to market the drug thalidomide. Despite what she called un-relenting pressure from the manufacturer, she remained unconvinced of the drug’s safety especially its potential effects on the unborn.

Dr. Kelsey’s decision has been described as a game changer for the Agency and the country. Her action spared untold numbers of children in the United States from devastating birth defects caused by the drug and spurred the passage of legislation that gave the FDA authorities it needed to better protect the public health; setting it on a course to become the nation’s premier public health agency that it is today.

On Wednesday September 15th at 10:30 AM I will present a new Commissioner’s award, The Dr. France O. Kelsey Award for Excellence and Courage in Protecting the Public Health, to its first recipient, Dr. Kelsey herself. This award will be given on a regular basis by the FDA Commissioner to selected FDA employees.”

Congratulations to Dr. Kelsey. She certainly deserves the honor.

UPDATE: NY Times article on the event

Read Dr. Kelsey’s Bio from Chemistry Explained. It tells how she and her husband were among the first scientists to verify that some drugs that are safe for adults are dangerous to human embryos. Very interesting reading.

Save The Date: On 4-5 November 2010 the Pacific Regional Chapter of the Society for Quality Assurance (PRCSQA) and the Organization of Regulatory and Clinical Associates (ORCA), a Pacific Northwest based organization, will co-sponsor a Fall Training on regulatory compliance topics in Seattle, WA.

The PRCSQA LinkedIn Group will update the agenda for the training. PRCSQA Fall Training workshops have traditionally been “at cost” and are an affordable training opportunity. The sessions will cover both GCPs and GLPs with speakers lined up on vendor management, quality systems, and GLP updates.

++++In news from GxP Perspectives++++

Read the updated article on the Form FDA 1572 in:

Applied Clinical Trials “Closing Thought” on FDA 1572

ALSO: Please join me on LinkedIn at:

GxP Perspectives LinkedIn Group

Share/Bookmark


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