This guidance was written prior to the February 27, 1997 implementation of FDA's 
Good Guidance Practices, GGP's. It does not create or confer rights for or on any person 
and does not operate to bind FDA or the public. An alternative approach may be used if 
such approach satisfies the requirements of the applicable statute, regulations, or borh. 
This guidance will be updated in the next revision to include the standard elemnts of GGP's.  - 
PART Ill  GUIDANCE ON SCIENTIFIC AND TECHNICAL INFORMATION 
........................ -P  
Introduction t.o. M..as.te.r. F.i.l.es. f.o.r. D.e.v.i.ce.s. (.M.A.P.S.). ......................... 1 
Definitions  .................................. I 
Types of MAPS and Their Functions  .............................. 1 
The Format and Arrangem.e.n.t .of. .an. .M.A.P. ............................... 1 
The Content of an M.A.F. ........................................... I 
AmendinganMAF  ......................................... 1 
Authorization to an MAY  .............. I 
Good Manufacturing Pr.ac.t.ic.e. .R.e.gu.l.a.ti.on.s. f.o.r. M..e.di.c.al. D..ev.i.ce.s. ............... 1 
Representing an MAF  ......................................... I 
Where to Submit an MAF  .............................. I 
Freedom of Information Act and an MAF. ............................... I 
CDRH Contact Office for Assistance  1 
Introdaction to Master Piles for Devices (MAFs) 
A  premarket  approval application  (PMA)  or  an  investigational  device exemption 
application (IDE) usually contains data and other information  that the applicant has 
developed and regards as trade secret or confidential commercial/financial information. 
Often the applicant needs to use another party's  product (e.g.,  ingredient,  subassembly, 
or accessory) or facility in the manufacture of  the device.  In order that a sound scien- 
tific evaluation may be made of the PMA, IDE, or other device submission, the review 
of data and other information related to the other party's  product,  facility, or manu- 
facturing procedures is required.  The other party, while willing to allow FDA's  confi- 
dential review of  this information,  may not want the IDE or PMA applicant to have 
direct access to the information.  To help preserve the trade secrets of  the ancillary 
medical device industry and at the same time facilitate the sound scientific evaluation 
of medical devices, FDA established the device master file system. 
This guideline only applies to the master files (MAFs) submitted to the Center for . 
- 
Devices and Radiological Health (CDRH).  Master  files in support of  other products 
regulated by FDA, even though they may contain information previously submitted in an 
MAP,  are to be submitted to the appropriate FDA center(&  The content and the way 
the master file is used may vary among FDA centers. 
Other master files submitted for review in support of documents filed with FDA are: 
Biologics Master Files supporting Notices of  Claimed Investigational Exemption 
for a New Drug (INDs) for biologics and biologic licenses. 
Drug Master  Files  (DMFs) supporting Investigational  New  Drug Applications 
(INDs), New  Drug Applications (NDAs), and .Abbreviated New  Drug Applications 
(ANDAs). 
a  Food Master Files (PMFs) supporting Pood Additive and Color Additive Petitions. 
Veterinary  Medicine  Master  Files  supporting  Investigational  New  Animal 
Exemptions (INADs) and New Animal Drug Applications (NADAs).  The following list identifies the appropriate offices to which these master files are to be 
submitted and from which information aan be obtained: 
Biologics Master Files  Drug Master Piles 
Div. of Biological Investigation New Drugs  Div. of Drug Information Resources 
Food and Drug Administration (HFN-823)  Drug Informat ion Services 
5600 Fishers Lane  Food and Drug Administration (HFN-84) 
Rockville, MD  20857  5600 Fishers Lane 
Telephone:  (301) 443-4864  Rockville, MD  20857 
Telephone:  (301) 443-3910 
Food Master F fles  Veterinary Medicine Master Files 
Div. of Food and Color Additives  Document Control Section 
Food and Drug Administration (HPF-330)  Food and Drug Ad midst rat ion (HPV-IS) 
200 C Street, S.W.  5600 Fishers Lane 
Washington, D.C.  20204  Rockville, MD 20857 
Telephone:  (202) 472-5678  Telephone:  (301) 443-1567 
The  following are  commonly  used  terms  relating to  MAFs  for  devices  and  the 
documents referring to them: 
a*- An "MAP holdern is an organization or person filing an MAF. 
a  An napplicant" is an organization or person filing a PMA. 
a  A nsponsor" is an organization or person filing an IDE. 
a  An  "agent  or representative for  an  MAF  holdern is a  person  or  organization 
authorized to represent the MAP holder before FDA concerning the contents of 
the MAP. 
Types of MAFs and Their Punctione 
, 
I 
MAFs are only accepted from those organizations or persons who have not submitted 
or  will  not  directly  submit  the information  in  a  PMA,  IDE,  premarket  notification 
(510(k)) or other device-related  submission to FDA.  MAPS may be submitted for various 
functions.  These functions have been grouped by the folIowing types: 
1 
facilities and manufacturing procedures and controls; 
synthesis,  formulation, purification  and specifications for chemicals,  materials 
(e.g.,  an alloy, plastic, etc.) or subassemblies for a device; 
packaging materials, 
contract packaging and other manufacturing (e.g.,  sterilization); 
noncllnical study data; and 
clinical study data.  The Format and Arrangement of an BfAF 
An MAP is a working document retained in the PMA  Document Mail  Center until 
referred to in a PMA,  IDE, or other type of  submission.  To assure its convenient use, 
maintenance and storage, CDRH has established the following suggestions for its format 
and arrangement. 
Submit two complete and identical paper copies.  In lieu of  two paper copies, 
CDRH will accept one paper copy and a copy on microfiche. 
If paper, collate both copies. 
Number each volume and each page within each volume. 
Standard page dimensions for FDA files.  Measurements are in inches,  In  the  first  volume  of  each  copy  include  a  signed  and  dated  cover  letter 
identifying the submission as a device master file (MAP) and briefly describe the 
subject of the submission. 
U.S.  standard size and weight bond  paper (8*  inches x  11 inches) is preferred. 
Page sizes should not exceed 11 inches in length and 8f inches in width. 
FDA's system for storing MAFs requires that the volume be bound on the left side 
of the page using the U.S. standard size loose leaf page. 
Should it be necessary to use individual pages larger than the U.S.  standard page 
size to present  a floor diagram, device design,  electrical diagram,  etc.,  those 
pages should be mounted to allow the page to be opened for review  and folded 
without damage when the volume is shelved. 
Allow a left margin of at least 3/4 inch to assure that the text is clear of binding. 
Individual volumes should not exceed 2 inches in thickness. 
DO NOT BIND volumes in book form or with plastic or metal spirals. 
The Content of an MAP 
A submission will not be accepted as an MAF if  it is not substantive in nature and 
does not contain information that may reasonably be regarded as trade secret or confi- 
dential commercial or financial information. 
The submission must include a cover letter, preferably bearing company letterhead, 
signed  by  a  responsible  official  (e.g.,  Director  of  Regulatory  Affairs  or  another 
manager).  The letter should identify the submission as an MAF, and a contact person at 
the company or designated agent should be listed. 
An  MAP must be in the English language or be accompanied  by  accurate English 
translations of any of the documents that are in a language other than English. 
i -  
Amending an MAP 
After submission of an MAP, its information may need to be updated as a result of 
additional testing, additional applications of the MAF information or modification of the 
product that is the subject of the MAP. 
Changes made in product or manufacturing operations can affect a client's  medical 
device and possibly result in the client marketing a device differing from that originally 
approved by FDA.  This can also have an effect on product liability obligations and a 
client's  compliance with applicable FDA laws and regulations.  It is,  therefore,  nec- 
essary  to notify  a client  before  proposed  changes  are  made  in  your  operations or 
product.  Authorization to an MAP 
Information in an MAP may be incorporated by reference in a client's  PMA,  IDE, or 
other submissions to FDA.  Their use of  information in an MAF can only be authorized 
by the MAF holder or by a designated agent if so authorized.  This authorization must be 
on company letterhead or that of the agent or representative.  After FDA has referred 
to an  MAF  and  the client's  application  has  been  approved,  authorization cannot  be 
withdrawn, 
An MAP holder should provide  a letter of  authorization  directly to a  client with 
instructions that:  (1) the original of the authorization letter be included in the original 
copy of the client's  submission and (2) a copy be placed in each subsequent copy of the 
client's submission.  An authorization letter should not  be sent directly to CDRH for 
inclusion in the MAF or the client's submission. 
Below is the format for a sample authorization letter. 
[Use company  letterhead  stationery  giving  company  name,  address,  and  telephone 
number.] 
[Date l 
[Client%n ame] 
[Mailing address including City, State and Zip Code] 
Dear [Person responsible for filing the client's application]: 
This letter authorizes the Food  and  Drug  Administration to include by  reference 
information  in our device  master file, MAP  #[%pecify the COl~8ctM  AF nwnber] for 
[specify the subject of the MAF, e.g.,  PMA,I DE or 510Q1  in [specifyt he client's device 
by generic or trade name]. [Yw may add further restricting wording if you desire]. 
,  2 
Sincerely yours, 
[Name and  title of  the person  respon- 
sible for MAF authorizations]  Good Manufacturing Practice Regulations for Medical Devices 
Organizations  or  persons  who  submit  IDEs,  PMAs, or  other  device-related  sub- 
missions to FDA may utilize contract manufacturers, sterilizers, packagers, etc. in the 
manufacture of their devices.  The latter, for trade secret or confidentiality purposes, 
may submit a description of  its facilities, manufacturing procedures and processes,  and 
quality control procedures in an MAP rather than provide this information directly to 
the client for inclusion in Its submission. 
In  its evaluation  of  the  client's  submission, FDA may  inspect  the  MAF holder's 
facilities and manufacturing operations.  When the MAP holder's operation is subject to 
the Good Manufacturing Practice (GMP)r egulations for medical devices (21 CFR 820), 
the MAP must address all appropriate GMP requirements applicable to the MAF holder's 
operation.  A client's submission may be adversely affected if the MAP is incomplete or 
inaccurate.  This is especially  true in  the case of  a PMA  because  of  the statutory 
requirement that a PMA  contain  a  full description of  the methods used  in,  and  the 
facilities and controls used for, the manufacture, processing, and when relevant, packing 
and installation of the device. 
Representing an HAP 
If an MAF submitter is a foreign company, FDA recommends that it retain an agent 
or representative in the United States.  This will usually facilitate any clarification or 
correction of deficiencies in the MAF information.  Identify any agent by name, address, 
and telephone number and specify any limitations in the authority of the agent or repre- 
sentative.  If limitations are not specified, FDA will assume that all information in the 
MAF may  be  discussed  with  the  agent  or representative.  A  designated  agent  or 
representative can be added or removed only by amending the MAP. 
Where to Submit an MAF 
An MAF and all amendments should be submitted to: 
Food and Drug Administration 
Center for Devices and Radiological ~eaith 
PMA Document Mail Center (HFZ-401) 
1390 Piccard Drive 
Roekville, MD  20850 
SPECIAL  NOTE:  FDA  will  not  pay  any  shipping  or  C.O.D. charges  for  incoming 
submissions or pick-up  MAPS from the carrier.  It is the submitter's  responsibility  to 
assure prepaid delivery to the above address. 
Receipt will be acknowledged by letter of all new MAP submissions.  FDA's acknowl- 
edgment  letter  of  the original  MAF will  include  the  FDA  assigned  MAF reference 
number which must be included in all amendments to the MAF, 
Freedom of Information Act and an MAP 
Under the Freedom of Information Act (POI), information in 510(k)s, IDEs, PMAs and 
other device-related  submissions is subject  to public disclosure unless determined by 
FDA to be trade secret or confidential commercial or financial information within the  meaning of 21 CFR 20.61 or otherwise prohibited from public disclosure.  In the case of 
PMAs,  FDA is required to make publicly available a detailed summary of  safety and 
effectiveness fnforrnation which is the basis for the FDA decision to approve, or deny 
approval of, the PMA.  Information in such summaries cannot be used to establish the 
safety or effectiveness for another device by any person other than the one who sub- 
mitted the information. 
FOI public disclosure provisions apply whether or not the information in the 510(k), 
IDE,  PMA,  or other device-related  submission was submitted by  the applicant or is 
included by authorized reference to an MAF. 
MAF holders should identify information in their MAFs which they consider to be 
trade secret or confidential commercial/ffnancial Information within the meaning of 21 
CFR 20.61.  MAF information already in the public domain is subject to disclosure (e.g., 
any published literature, catalog, or product specification sheets distributed by the MAP 
holder to potential customers). 
CDBH Contact Office for Assistance 
Procedural and other questions regarding MAFs should be directed to: 
Food an8 Drug Administration 
Center for Devices and Radiological Health 
Premarket Approval Staff (HFZ-402) 
1390 Piccard Drive 
Roakville, MD  20850 
Telephone (301)427-1188 
Additional copies of  the MAF Guideline are available from the above office and the 
CDRH Division of Small Manufacturers Assistance.  Telephone requests will be accepted 
by the latter office by calling (800)638-2041 or (301)443-6597.