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U.S. Department of Health and Human Services

Medical Devices

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Document Control Procedures - September 26, 1990 (I90-3)

Note: The Blue Book Memo, Fax & E-mail Communication with Industry about Premarket Files Under Review A02-01 supersedes the sections entitled, “Information Received via Telephone” and “Facsimile Transmission (Fax)” in the Blue Book Memo “Document Control Procedures (I-90),” issued September 26, 1990.


Program Integrity Memorandum #I90-3

 

September 26, 1990



Document Control Procedures

Purpose.

The purpose of this memorandum is to set forth procedures for receipt, 
tracking, and security of documents received by ODE.  It covers document 
log-in, "desk copies," telephonic and facsimile transmissions, and work 
at home.  These procedures are designed to assure fair and equal 
treatment for all members of the regulated industry.  They also help 
assure the authenticity and security of submissions to ODE for review and 
decision.

Incoming Documents.

All submissions received for review by ODE, i.e., PMAs, IDEs, 510(k)s, 
and their amendments and supplements, must be processed through the 
Document Mail Center (DMC) within the Program Operation Staff (POS) 
Office.  The DMC staff will log-in the submissions and they or other POS 
staff members, i.e., PMA, IDE, or 510(k) staffs, will route them to the 
appropriate ODE divisions.  Each type of document may have a special 
procedure required for its routing to the divisions.  For example, in the 
case of PMAs, the DMC will route them to the PMA staff who will 
distribute them to the appropriate divisions.  These procedures also 
apply to extra copies of submissions requested for panel members or other 
Center or FDA reviewers.

Other correspondence sent to ODE, i.e., letters, memoranda, notes, and 
other correspondence not concerning the merits of a document that is, or 
will become, a submission for review, will be received in the building's 
general mail room and distributed directly to the addressee's mail stop.  
Local mail stop personnel will be responsible for managing such 
correspondence according to their current practices.  If a submission for 
review that has not been processed by the DMC is received in a division, 
it should be taken to the DMC for proper processing before any review is 
initiated.

"Desk Copies".

All submissions for review within ODE must have been received and 
logged-in by the DMC.  ODE staff may not accept for review submissions or 
copies of submissions that have not been properly processed through the 
DMC.  In the past, such copies, often referred to as "desk copies", have 
been acceptable, with the knowledge of Office and Center management, 
because certain efficiencies in document review could be realized.  It is 
now clear that this practice can lend itself to unequal treatment, i.e., 
unequal review times between submissions received as desk copies and 
those that have gone though "normal" channels only.  There is the 
additional problem that desk copies may not contain the identical 
contents of the documents officially filed.  This could raise a suspicion 
that some decisions are based upon incomplete or erroneous information.  
Therefore, this practice will no longer be acceptable.

Information received Via Telephone.

As a general rule, information and data required to review and reach a 
decision on a submission may not be accepted via telephone.  An exception 
to this rule can be made for information that is needed to correct minor 
deficiencies, answer simple questions, or to obtain clarifications, 
provided this can be accomplished through a telephone conversation of 
reasonable length and complexity.  Also, a telephone call may be used to 
arrange meetings, confirm attendees at a meeting, prepare an agenda and 
for other purposes that do not relate to the data or information that 
will be considered in making a decision on a pending application.

Facsimile Transmission (Fax).

The Office of Device Evaluation supports the use of modern technology for 
communications with the regulated industry and other members of the 
public.  This would include fax transmissions as well as other means of 
electronic data transmission.  Use of these means of communications have 
proven to be reliable and accurate.  At the same time they save time and 
reduce duplication of work.  One problem remains that prevents ODE from 
engaging in the full utilization of these new technologies: we do not 
have enough equipment and personnel to adequately serve the volume of 
traffic that would arise.  Since we cannot serve everyone, use of fax 
transmissions could result in preferential treatment to a few applicants.  
Therefore, until ODE can become fully operational in the use of faxes and 
other means of electronic transmissions, we will follow the guidance set 
forth immediately below.

As a general rule, information and data required to review and reach a 
decision on a submission may not be accepted via fax.  All submissions 
must meet any applicable regulatory requirements concerning the number of 
copies, original signature, etc. as set forth in the Code of Federal 
Regulations, as amended.  See, for example, 21 CFR 807.90(c) and 
814.20(a).  If an unsolicited submission is received via fax, the 
submitter should be notified and the fax copy disposed of with other 
materials designated for incineration.

An advance copy of an Agency decision should not be sent by fax to any 
applicant.  Unless this were done for all applicants, which we are not 
set up to do, it would constitute preferential treatment for those who 
sent the advance notice.

There are times when the ODE staff finds it necessary or expedient to 
engage in the exchange of ideas with an applicant concerning the wording 
of long and complex documents.  Under these circumstances, it may be 
appropriate to use fax transmissions to facilitate the exchange of ideas, 
with the proviso that no data or final labeling that are to be part of an 
official filed are accepted via the fax.  Before engaging in such 
exchanges, reviewers should discuss it with their supervisors.  Also, a 
fax may be used to arrange meetings, confirm attendees at a meeting, 
prepare an agenda and for other purposes that do not relate to the data 
or information that will be considered in making decision on a pending 
application. These fax transmissions may be retained in the appropriate 
files for future reference.

If materials are to be sent to a commercial FAX service and the addressee 
of the FAX, e.g., a panel member, will seek reimbursement from FDA for 
the FAX charges, prior approval is required from the ODE Program 
Management Office.  If reimbursement will not be requested from FDA, 
prior approval is not required.

Work at Home.

From time to time it is desirable for an ODE staff member to take 
official submissions home for further work during nonbusiness hours.  
This practice has been beneficial to ODE in meeting its legal time frames 
and providing efficient service to the public.  The Office of the 
Inspector General has expressed concern for the physical security and 
confidentiality of documents removed from the premises.  ODE and Center 
management believe that the benefits of taking work home outweigh the 
risks involved and wish to support and encourage its continuation.  It 
would, however, be prudent to provide certain safeguards.  Therefore, 
each Division and Office from which work is taken home will establish a 
log in which a reviewer taking work home will record the date and a brief 
identification of the document being removed from the premises.  Upon 
return of the document, the reviewer, for his/her own protection, should 
record the date of return in the log entry for that document.

Employees should remember that it is their responsibility to properly 
safeguard all privileged information while it is in their possession.  
They must also make sure that the privileged information or related 
material is not destroyed, altered, etc., while it is removed from the 
office.

[NOTE:  This guidance on "Work at Home" is intended to be consistent with 
provisions that are currently being incorporated into the FDA staff 
manual guide.  If necessary, this guidance will be adjusted to conform to 
the policies ultimately adopted by the Agency.]

Effective Date.  

This guidance is effective immediately.