Guidance For Industry And Food And Drug Administration Staff - U.s. Department Of Health And Human Services - 2012 Page 7
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13Contains Nonbinding Recommendations
Section 513(g) of the FD&C Act (21 U.S.C. 360c(g)) provides a means for obtaining the
agency's views about the classification and the regulatory requirements that may be
applicable to your particular device. This provision states:
Within sixty days of the receipt of a written request of any person for information respecting
the class in which a device has been classified or the requirements applicable to a device
under this Act, the Secretary shall provide such person a written statement of the
classification (if any) of such device and the requirements of this Act applicable to the
device.
Section 513(g) governs requests "for information respecting the class in which a device has
been classified or the requirements applicable to a device under [the] Act." Submissions that
do not request such information are outside the scope of section 513(g).
If, based solely on the information provided with a 513(g) Request for Information, the
product at issue does not appear to be a "device" within the meaning of section 201(h) of the
FD&C Act (21 U.S.C. 321(h)), FDA will so inform the requester in our response. If, based
solely on the information provided with the request, the product does appear to be a "device"
within section 201(h) of the FD&C Act, FDA will generally provide the following
information regarding device classification and applicable FDA regulatory requirements:
· the agency's assessment, based on the information submitted in the request, as to the
generic type of device (e.g., classification regulation) that the requester's device
appears to be within (if any);
· the class of devices within that generic type (and if there is more than one class
within that generic type, the particular class within which the requestor's device
appears to fall);
· whether a PMA, 510(k), or neither is required in order to market devices of the
particular class within that generic type;
· other requirements applicable to devices of the particular class within that generic
type;
· whether a guidance document has been issued regarding the exercise of enforcement
discretion over the particular class of devices within that generic type;
· whether additional FDA requirements may apply, such as those applicable to
radiation-emitting products.
FDA does not review data related to substantial equivalence or safety and effectiveness in a
513(g) Request for Information. FDA's responses to 513(g) Requests for Information are not
device classification decisions and do not constitute FDA clearance or approval for
marketing. Classification decisions and clearance or approval for marketing require
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