The PMA applicant is usually the person who owns the rights, or otherwise
has authorized access, to the data and other information to be submitted
in support of FDA approval of the PMA. This person may be an individual,
partnership, corporation, association, scientific or academic establishment,
government agency or organizational unit, or other legal entity. Often
times the applicant is the inventor/developer and ultimately the manufacturer.
If the applicant does not reside or have a place of business within
the U.S., the PMA must be countersigned by an authorized representative
who does. [§814.20]
Are data from foreign clinical studies accepted
by FDA?
A study conducted under an investigational device exemption (IDE) outside
the United States and submitted in support of a PMA must comply with
the IDE regulation (21
CFR 812). A study conducted outside the U.S. which was not conducted
under an IDE must comply with one of the following:
• Research begun on or after effective date November 19, 1986:
FDA will accept studies which have been conducted outside the U.S. and
begun on or after November 19, 1986, if the data constitute valid scientific
evidence (§860.7)
and the investigator has conducted the studies in conformance with the
"Declaration of Helsinki" or the laws and regulations of the
country in which the research was conducted, whichever offers greater
protection to the human subjects. If the standards of the country are
used, the applicant must state in detail any differences between those
standards and the Declaration of Helsinki and explain why the national
standards offer greater protection to the human subjects.
• Research begun before effective date November 19, 1986: FDA
will accept studies which have been conducted outside the U.S. and begun
before November 19, 1986, if the agency is satisfied that the data constitute
valid scientific evidence (§860.7)
and that the rights, safety, and welfare of human subjects have not
been violated.
A PMA based solely on foreign clinical data and otherwise meeting the
criteria for approval under this part may be approved if:
• the foreign data are applicable to the U.S. population and
medical practice;
• the studies have been performed by clinical investigators of
recognized competence; and
• the data may be considered valid without the need for an on
site inspection by FDA or, if FDA considers such an inspection to be
necessary, FDA can validate the data through an on site inspection or
other appropriate means.
Applicants who seek approval based solely on foreign data are encouraged
to meet with FDA officials in a presubmission meeting.
Additional guidance on FDA policy regarding the acceptance of foreign
clinical data can be found in the following document.
How does the sponsor notify FDA of a change in
address of the official correspondent for the PMA under review?
FDA will send all PMA correspondence only to the designated official
correspondent of the PMA. The sponsor can change the name or address
of the official correspondent by submitting an amendment to the PMA.
Is FDA approval required to change the trade
name of the device?
Yes, the sponsor must submit a PMA supplement and receive approval
before the change in trade name can be implemented.
Can the sponsor sell the PMA to another company?
How does the owner notify FDA of a change in ownership?
Yes, a PMA may be sold to another company. The sponsor must submit
a PMA amendment to notify FDA of the new owner. The new sponsor is responsible
for complying with the PMA regulatory requirements as well as all other
applicable regulations such as registration, listing, quality system,
and medical device reporting. The PMA reference number will remain the
same.
Ownership of a PMA may be transferred at any time, i.e., before or
after FDA approval. At the time of the transfer, the former owner should
provide an original and a copy of a letter (preferably on the letterhead
of the former owner and signed by an appropriate company official) to
be used to notify FDA that all rights of the PMA have been transferred
to the new owner.
If the PMA has been approved, the new owner need only report that the
transfer of PMA ownership will not result in a change or modification
that would require a submission of a PMA supplement (§814.39)
or affect the conditions of approval applicable to the PMA. If changes
are made that require a PMA supplement (§814.39)
or affect the conditions of approval, the new owner must submit an appropriate
PMA supplement and obtain written FDA approval before marketing the
device.
The above amendment or supplement should also include:
the effective date of the ownership transfer;
a statement of the new owner’s commitment to comply with all
the conditions of approval applicable to the PMA; and
either a statement that the new owner has a complete copy of the PMA
including all amendments, supplements, and reports or a request for
a copy from the FDA files. FDA will provide a copy of the PMA under
the Freedom of Information fee schedule. [21
CFR 10.42]
A change in manufacturing or product sterilization site and certain
changes to the device, labeling, or packaging require prior FDA approval
through a PMA supplement. See PMA amendments and supplements for further
guidance on when a PMA supplement is required.
If the transfer of ownership occurs before the PMA is approved, the
PMA must be amended to include the applicable information and ownership
transfer letter described above.
Can the PMA holder enter into a licensing agreement
with another manufacturer?
When the holder of an approved PMA enters into an agreement to permit
another firm (hereafter referred to as the licensee) to manufacture
and distribute a device under the licensee’s private label, FDA
approval may be obtained by the following procedure:
The licensee may submit an original PMA that includes, or includes
by authorized reference to the holder’s approved PMA, all appropriate
information required by 21
CFR 814.20.
After the licensee’s PMA is approved, the original PMA holder
may not rescind any authorization permitting the licensee’s use
of information in the original approved PMA. The licensee may also use
that same information in support of changes or modifications later proposed
by the licensee. The licensee becomes independent of the original PMA
holder and should submit all required PMA supplements and periodic postapproval
reports directly to FDA.
The PMA submission must include the following:
a statement signed by both parties confirming that the original PMA
holder has furnished the licensee with a complete copy of all manufacturing
information in the approved PMA applicable to the licensee’s manufacture
of the device;
a complete description of a licensee’s manufacturing facilities
and a listing and explanation of all differences between the original
PMA holder’s and the licensee’s methods and controls used
in the manufacture, processing, packing, storage, and, when appropriate,
installation of the device;
process validation and expiration dating information, where appropriate;
copies of all required labeling (draft or final) and a description
of all differences between the PMA holder’s and the licensee’s
labeling (e.g., a markup of the PMA holder’s approved labeling
identifying the revisions incorporated in the licensee’s labeling;
a description and the results of all tests and evaluations which demonstrate
that the licensee’s device is identical or sufficiently similar
to the PMA holder’s device to the extent that there is reasonable
assurance that the licensee’s device is safe and effective for
the intended use; and
the licensee’s FDA establishment registration number and, if
applicable, the dates of the most recent FDA inspection of the licensee’s
manufacturing facility.
Can the sponsor change the manufacturing site
of the PMA approved device?
Yes, however, the sponsor must receive FDA approval of the new manufacturing
site prior to distributing product that was manufactured at the new
facility. Information on the PMA Manufacturing Site Change Supplement process can be
found in the guidance document "Draft Guidance: Likelihood of Facilities
Inspections When Modifying Devices Subject to Premarket Approval"
http://www.fda.gov/cdrh/comp/likehood.html
Does an extension of product shelf life require
a PMA supplement?
If FDA has previously reviewed and accepted a protocol for changes
to the expiration date and testing was performed in accordance with
that protocol, the change to the expiration date can be made and reported
in an annual report. If not, a PMA supplement should be submitted. Additional
guidance can be found in "Modifications to Devices Subject to Premarket
Approval - The PMA Supplement Decision Making Process; Draft")
http://www.fda.gov/cdrh/ode/pumasupp.pdf
How can I find more information about a PMA
under review?
Before FDA approves or disapproves a PMA, FDA will not disclose the
existence of the PMA unless it previously has been publicly disclosed
or acknowledged. Even if the existence of the PMA has been publicly
disclosed or acknowledged, data or information contained in the file
are not available for public disclosure. However, FDA may disclose a
summary of portions of the safety and effectiveness data, if disclosure
is relevant to public consideration of a specific pending issue. [21
CFR 814, 21
CFR 20]
Can I obtain a copy of a PMA submission?
Upon approval (or denial of approval) of any PMA, FDA will publicly
reveal the existence of the PMA and provide a detailed summary of the
information submitted to FDA about the safety and effectiveness of the
device. The approval order, summary of safety and effectiveness, and
product labeling are available on the Internet and are linked from the
searchable PMA database. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm
In addition, the following types of information in the PMA file are
available for public disclosure after deletion of any trade secret,
confidential commercial or financial information, or any other information
that if disclosed would constitute a clearly unwarranted invasion of
personal privacy, e.g., personnel, medical, and similar information.
The releasable information includes:
all safety and effectiveness data and information previously disclosed
to the public;
any protocol for a test or study;
any adverse reaction report, product experience report, consumer complaint,
and other similar data and information;
a list of components previously disclosed to the public;
an assay method or other analytical method; and
all correspondence and written summaries of oral discussion relating
to the PMA file.
The following types of information are not available for public disclosure
unless they have been previously disclosed to the public, relate to
a device for which a PMA has been abandoned, or no longer represent
a trade secret or confidential commercial or financial information:
manufacturing methods or processes including quality control procedures;
production, sales, distribution, and similar data and information;
and
