New Draft FDA Guidance for Applicability of GLP in Medical Device Submission

Y

yana prus

Hi,

A new draft guidance document released by the US Food and Drug Administration (FDA) explains that good laboratory practice (GLP) regulations under 21 CFR 58 generally apply to medical device premarket and research applications.
Examples of nonclinical laboratory studies include in vitro and in vivo biocompatibility testing and animal studies used to evaluate the potential for adverse responses to a medical device. Bench tests, such as chemical or physical testing, and any other studies that do not involve use of an animal, plant, or microorganism, are not included

The main points of the draft guidance are:
1) GLP applies only to nonclinical laboratory studies submitted in support of a research or marketing application for a regulated product; Therefore, basic exploratory studies carried out to determine whether a device has any potential utility, or to determine physical or chemical characteristics of a device, are not subject to the GLP regulations

2) GLP does not apply to studies utilizing human subjects, human specimens, clinical studies, or field trials in animals;

3) the scope is limited to safety studies (functionality studies are excluded); and

4) the scope is confined to studies performed on animals, plants, microorganisms or subparts thereof.

The preamble does not distinguish between drug or device applications nor between premarket approval (PMA), humanitarian device exemption (HDE), premarket notification (510(k)), or investigational device exemption (IDE) submissions;
The preamble states that "no compelling reasons have been presented that would support the contention that assurance of safety is less desirable for one class of regulated products than for another." (43 FR 59989)
 
M

maryloup

Hi All,
I have a question here if testing for chemical characterization after an extraction should have validated analytical methods? I explained what I mean some labs can perform chromato, gravimetry but they don't validate the methods, is it a problem for FDA acceptance (510(k))? Is it mandatory to make validated the methods by the lab? Thanks;
 

Ronen E

Problem Solver
Moderator
Hi All,
I have a question here if testing for chemical characterization after an extraction should have validated analytical methods? I explained what I mean some labs can perform chromato, gravimetry but they don't validate the methods, is it a problem for FDA acceptance (510(k))? Is it mandatory to make validated the methods by the lab? Thanks;

What is the purpose of the "testing for chemical characterization after an extraction"?

Your question needs a context to be correctly answered.
 
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