FDA's guidance - Evaluation of Sex-Specific Data in Medical Device Clinical Studies

rangani_rj

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#1
Hi All,

FDA just published this final guidance. It identifies and addresses those issues to be considered during clinical studies to gain sex based difference in clinical outcome of medical device i.e. Barriers to enrollment of women, recommendations, statistical consideration, poolability of data etc.

Because of hormonal (and so physiological) differences, certain devices work differently in male and female i.e. (as given in guidance)

1. Ventricular Assist Devices (VADs): A higher rate of stroke (18% vs. 6%), bleeding and infection found in women as compared to men.
2. Cardiac Resynchronization Therapy Defibrillators (CRT-D): CRT-D therapy more effective in woman over ICD (77% versus 42% in man).
3. Total hip replacement (THR) revision surgery: Revision surgeries in THR are to be required for patients feeling discomfort after few years (due to wear and tear of devices or detachment of implant from bone). Rate of revision surgery is higher in among women (19.8% vs 14.6% in man).

Decision framework is provided at the end of document.

Guidance is meant for devices used in both genders, not for devices exclusively used in female i.e. Gynecology/obstetric products, which are obviously tested on female patients.
 

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#2
Re: FDA's guidance - Evaluation of Sex-Specific Data in Medical Device Clinical Studi

A Quick Bump!

In case you missed this post + attachment.
 
B

bobbles1987

#3
Re: FDA's guidance - Evaluation of Sex-Specific Data in Medical Device Clinical Studi

Hi all :bigwave:

Is anyone aware of any guidance from FDA based on physical attributes of the volunteers - ie body shape?

Many thanks in advance.
 

rangani_rj

Involved In Discussions
#4
Re: FDA's guidance - Evaluation of Sex-Specific Data in Medical Device Clinical Studi

Hi,

Guidance documents does not specify exact values for physical attributes to be considered for clinical trial, instead physical attributes are decided by sponsor based on his past experience and need to be included in protocol before it is approved by IRB. Physical attributes again differ from one device to another and it is based on many factors. i.e. type of population (Pediatric, adult, Geriatric, Male vs Female) for which devices to be used.

If possible, provide more detail.
 
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