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FDA Regulations say a Component or Accessory
to a Medical Device is a Medical Device
This can be a difficult part of the regulation to fully
grasp and apply. Mainly because there are a lot of factors that add to the
complexity of the issue.
The medical device definition provided by the FDA is useful when distinguishing
differences between products such as pharmaceuticals, however falls short of
defining the subtle inferences of components and accessories on the overall
device.
In the US the FDA defines “Medical Device” as:
"an instrument, apparatus, implement, machine, contrivance, implant, in vitro
reagent, or other similar or related article, including a component part, or
accessory which is:
recognized in the official National Formulary, or the United States
Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of
disease or other conditions, or in the cure, mitigation, treatment, or
prevention of disease, in man or other animals, or intended to affect the
structure or any function of the body of man or other animals, and which does
not achieve any of it's primary intended purposes through chemical action within
or on the body of man or other animals and which is not dependent upon being
metabolized for the achievement of any of its primary intended purposes."
By US law, any manufactured good that is a component of or an accessory to a
medical device, is in itself - a medical device. FDA rules state that unless
separately classified, a component, parts or accessory to a medical device is
regulated in the same way as its parent device.
Products that are not sold with a medical function, but that are incidentally
used for a medical purpose, are legally general purpose articles and are exempt
from all requirements of the Act except for the prohibitions against
adulteration and misbranding. Products which are components of or accessories to
a medical device are normally regulated in the same way as the "parent" device.
For example, if the parent device is subject to GMPs and premarket notification,
the normal presumption is for an accessory to be subject to the same
requirements, even if marketed separately2. Furthermore, the manufacturer of a
device is responsible for assuring that the ultimate medical device, including
all components, complies with the regulations.
Safety and Effectiveness: Dealing with Component Suppliers
The medical device manufacturer is responsible for the safety and effectiveness
of all components, including any general-purpose articles incorporated within
the device.2
Whether by 100% component inspection or by approving the component supplier, the
ultimate medical device manufacturer is responsible for ensuring that the
finished product is safe and effective.
Still don’t know Whether your product is a medical device?
Device evaluation and classification activities (Section 513(g)) are carried out
by ODE, the Office of Compliance (OC) is bestowed with the responsibility
answering inquiries regarding whether or not a particular product is a medical
device and thus subject to Center regulatory authority (device determination).
If you have doubt as to whether your product is considered a medical device, the
best thing to do is to ask the FDA. You can do so at the following locations:
For products regulated by CDRH, requests for classification information under
section 513(g) of the act should be submitted to:
513(g) Coordinator,
Food and Drug Administration,
Center for Devices and Radiological Health,
510(k) Document Mail Center (HFZ-401),
9200 Corporate Boulevard, Rockville, MD 20850.
For products regulated by CBER, 513(g) requests should be submitted to:
CBER Ombudsman,
Center for Biologics Evaluations and Research,
Suite 200 North, HFM-4,
1401 Rockville Pike, Rockville, MD 20852-1448.
References:
Guidance for FDA Reviewers and Industry Guidance for the Content of Premarket
Submissions for Software Contained in Medical Devices
Telemedicine Related Activities Center for Devices and Radiological Health Food
and Drug Administration 11 July 1996
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