FDA Guidance: FAQ for
In Vitro Diagnostic
Medical Devices
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.“
ICH Good Clinical Practice Can Also Apply to Medical Device Studies
“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.“
Appendix 2 Shows Requirements for IRB Approval and Informed Consent
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
Posted by GxP Perspectives 
FDA To Honor Dr. Frances Kelsey
September 2, 2010President Kennedy Honors Dr. Frances Kelsey for Her Role in Drug 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
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