Guidance for Industry and FDA Staff
Revised Procedures for Adding
Lens Finishing Laboratories to
Approved Premarket Approval
Applications for Class III Rigid Gas
Permeable Contact Lenses for
Extended Wear
Document issued on: August 11, 1998
This document supersedes document, New Procedures for Adding
Lens Finishing Laboratories Through Supplements to Approved
Premarket Approval Applications for Rigid Gas Permeable Contact
Lenses, May 9, 1985
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Vitreoretinal and Extraocular Devices Branch
Division of Ophthalmic Devices
Office of Device Evaluation Preface
Public Comment
Comments and suggestions may be submitted at any time for Agency consideration to
James F. Saviola, O.D., Vitreoretinal and Extraocular Devices Branch (HFZ-460),
Division of Ophthalmic Devices, Office of Device Evaluation, Center for Devices and
Radiological Health, 9200 Corporate Blvd., Rockville, MD 20850.  Comments may not be
acted upon by the Agency until the document is next revised or updated.  For questions
regarding the use or interpretation of this guidance contact James F. Saviola, O.D., at
301-594-1744 or by electronic mail at JZS@cdrh.fda.gov.
Additional Copies
World Wide Web CDRH home page:  http://www.fda.gov/cdrh or CDRH Facts on
Demand at 1-800-899-0381 or 301-827-0111, specify number 1249 when prompted for
the document shelf number.
________________________________________
This document is intended to provide guidance.  It represents the
Agencys current thinking on the above.   It does not create or
confer any 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 both. TO: All Class III Rigid Gas Permeable Contact Lens PMA Holders and
                        Interested Persons
SUBJECT: Revised Procedures for Adding Lens Finishing Laboratories to
Approved Premarket Approval Applications for Class III Rigid Gas
Permeable Contact Lenses for Extended Wear
Introduction:
On May 9, 1985, the Center for Devices and Radiological Health (CDRH) of the Food and Drug
Administration (FDA) issued a document entitled New Procedures  For Adding Lens Finishing
Laboratories Through Supplements to Approved Premarket Approval Applications For Rigid Gas
Permeable Contact Lenses.  These procedures allowed small, independent contact lens finishing
laboratories (hereafter referred to as lens finishing laboratories) to manufacture and distribute
rigid gas permeable (RGP) contact lenses under another firms approved premarket approval
application (PMA) for an RGP contact lens, using the same material and design, for the same
indications for use, and under the same labeling as the lens covered by the approved PMA.  In
addition, the procedures provided for manufacturers with approved PMAs for RGP contact lenses
to submit 30-day supplements for additional lens finishing laboratories as manufacturers and
distributors of approved lenses.  The procedures stated that the PMA supplements will be deemed
approved 30 days after filing if all requirements in the document were met and the PMA
supplements were administratively complete. 
In accordance with 21 CFR 814.39 and as part of our re-engineering efforts in PMA review, 
FDA is revising the May 9, 1985 policy.  Under the revised policy, PMA holders may include
additional finishing laboratories as manufacturers and distributors of approved RGP lenses after a
protocol is approved, without submitting PMA supplements, provided the PMA holder agrees to:
1. provide the documentation listed under the heading Documentation, Annual Reports in
its future annual reports; and
2. include the information listed under the heading Documentation, Device Master Records
and Complaint Files in the device master records and complaint files to be made
available to FDA upon request.  Page 2 - All Class III Rigid Gas Permeable Contact Lens PMA Holders and Interested Persons
FDA believes that this revision can be implemented without compromising public health and
safety and that it will reduce the regulatory burden on manufacturers.  The procedures are
consistent with procedures for adding finishing laboratories for manufacturing and distributing
class II contact lenses, which are included in the May 12, 1994, guidance entitled PREMARKET
NOTIFICATION (510(k)) GUIDANCE DOCUMENT FOR DAILY WEAR CONTACT
LENSES.
NOTE:  THIS PROCEDURE REPLACES THE MAY 9, 1985, POLICY ENTITLED
"NEW PROCEDURES FOR ADDING LENS FINISHING LABORATORIES THROUGH
SUPPLEMENTS TO APPROVED PREMARKET APPROVAL APPLICATIONS FOR
RIGID GAS PERMEABLE CONTACT LENSES."  PLEASE NOTE THAT THIS
PROCEDURE APPLIES TO CLASS III RGP CONTACT LENSES ONLY; IT DOES
NOT APPLY TO SOFT  (HYDROPHILIC) CONTACT LENSES.  
Objectives:
Manufacturers Objective:  To obtain marketing approval for acceptable procedures to
allow one or more independent finishing laboratories to manufacture and distribute
finished RGP contact lenses made from lens blanks supplied by a manufacturer with a
previously approved PMA.
FDAs Objective:  To ensure that lenses finished by independent laboratories will conform
to the specifications of approved PMA or PMA supplements, to ensure safe and effective
RGP contact lenses, and to ensure that finishing laboratories will comply with all PMA
post-approval requirements.
Responsibilities:
FDA considers the finishing of RGP contact lenses by lens finishing laboratories to be an
extension of the manufacturing process for RGP contact lenses.  The PMA holder is ultimately
responsible for assuring that each finishing laboratory produces lenses that are essentially identical
to the approved lens and that all quality assurance activities necessary to determine that finished
contact lenses meet specifications are appropriate, adequate, and correctly performed.   Each
independent finishing laboratory is responsible for complying with those parts of the device Good
Manufacturing Practice Requirements, as set forth in the Quality System Regulation for medical
devices, which apply to the manufacturing operations that the finishing laboratory performs for
the PMA holder.
Requirements:
The PMA holder must receive FDA approval of a PMA or PMA supplement that contains a
protocol for adding additional finishing laboratories as manufactures and distributors of RGP
lenses before implementing the procedures in this document.  PMA holders with currently
approved protocols are not required to resubmit new protocols. Page 3 - All Class III Rigid Gas Permeable Contact Lens PMA Holders and Interested Persons
An approved contact lens PMA provides evidence that a lens material is not toxic, that the lens
can be cleaned and disinfected satisfactorily, that it can be manufactured according to
specifications and in compliance with Good Manufacturing Requirements, as set forth in the
Quality System Regulation for medical devices; and that it is clinically safe and effective for its
labeled indications.   These procedures specify the conditions under which independent finishing
laboratories may be included under an approved PMA or PMA supplement for class III RGP
contact lenses.
The information that should be submitted to FDA in a PMA or PMA supplement to obtain
approval of a protocol for adding additional finishing laboratories includes:
1. the information that the PMA holder plans to provide to the lens finishing laboratories 
pertaining to finishing the approved RGP lens (should be the same information as in the
approved PMA); and
2. the monitoring plan, and other information specified below which the PMA holder will 
use to evaluate the lens finishing laboratories to qualify them as manufacturers and
distributors of the approved RGP lens. 
The approved  protocol and monitoring plan for continued surveillance over each finishing
laboratory provide FDA with assurance of the PMA holders ability to evaluate lens finishing
laboratories in accordance with approved specifications.  The PMA approval, along with
documentation in the next annual report of the PMA holders evaluation of each lens finishing
laboratorys ability to manufacture the RGP lens to approved specifications, provide FDA with
reasonable assurance that approved finishing laboratories can manufacture lenses that are
essentially identical to those approved in the PMA.  Allowing PMA holders to qualify lens
finishing laboratories and provide documentation in the next annual report eliminates the
requirement of obtaining explicit FDA approval of a PMA supplement for adding additional
finishing laboratories as manufacturers and distributors of approved RGP lenses, when the
documentation listed on pages 7 and 8 are included in the PMA owners device master records and
complaint files.
Consequently, FDA has concluded that a contact lens finishing laboratory that is (a) evaluated by
a manufacturer holding an approved PMA for an RGP contact lens, in accordance with a protocol
approved by FDA in the same PMA or in a PMA supplement, and (b) found by the PMA holder
to meet all the requirements specified in this document, may begin manufacturing, selling, and
shipping the lens that is the subject of the approved PMA, in accordance with the conditions of
approval of the approved PMA, after the PMA holder has documented conformance with the
information specified in this document in the firms device master records and complaint files.   Page 4 - All Class III Rigid Gas Permeable Contact Lens PMA Holders and Interested Persons
Listed below are nine key quality assurance activities that FDA requires the laboratories to
perform as well as instructions to PMA holders for designing a protocol for the evaluation of a
laboratorys ability to manufacture the lenses and meet the quality assurance requirements.  The
information that should be provided to the lens finishing laboratories includes, but is not limited
to, the following:
1.  Complete range of specifications for the contact lenses, and detailed process instructions
for any manufacturing steps that require processing in a manner that is in any way unique
to the material from which the lenses are to be manufactured.
 
2.  Complete and accurate copies of all the labeling for distribution with the lens, as approved
by FDA in the PMA, including the cautionary statement, Caution:  Non-sterile.  Clean
and condition lenses prior to use.
 
3.  A detailed description of the following key quality assurance activities that lens finishing
laboratories are required to perform:
 
a)  incoming material specifications;
 
b)  acceptance/rejection criteria at each manufacturing step;
 
c)  identity and specifications for each processing compound, such as sealing waxes
and polishing compounds;
 
d)  cleaning instructions and specifications for cleaning compounds;
 
e)  final product acceptance criteria and test methods;
 
f)  identity and specification for packaging and labeling materials;
 
g)  disinfection instructions (or sterilization instructions if labeled as sterile) in
accordance with the approved PMA, process validation, and product release
procedures [please refer to the section entitled Microbiology Requirements for
Hydrophobic Contact Lenses, of the document entitled PREMARKET
NOTIFICATION (510(k)) GUIDANCE DOCUMENT FOR DAILY WEAR
CONTACT LENSES for guidance] ;
 
h)  records maintenance including device history records sufficient to ensure the
traceability of any lens to the lot or batch of material; as identified by the material
supplier, from which the lens was manufactured, and complete complaint files;
  Page 5 - All Class III Rigid Gas Permeable Contact Lens PMA Holders and Interested Persons
i) continuing quality audit procedures to be employed by the lens
finishing laboratories personnel in accordance with the definition
in the current Good Manufacturing Requirements, as set forth in the
Quality System Regulation for medical devices,  21 CFR 820.3(t),
which states:
 
Quality audit means a systematic, independent examination of a manufacturers
quality system that is performed at defined intervals and at sufficient frequency to
determine whether both quality system activities and the results of such activities
comply with quality system procedures, that these procedures are implemented
effectively, and that these procedures are suitable to achieve quality system
objectives.
To obtain approval of a protocol for adding lens finishing laboratories as manufacturers and
distributors of approved RGP lenses, the PMA holder must obtain approval of a PMA or PMA
supplement containing the following information for evaluation of the lens finishing laboratories,
and must ensure compliance with the conditions of approval of the PMA:
 
1. The information provided to lens finishing laboratories, as listed above. 
2. A satisfactory protocol for a presubmission evaluation of the laboratory.  This evaluation 
may include (a) an on-site inspection or (b) a questionnaire to be answered by the 
laboratory and reviewed by the PMA holder.  If the laboratory did not participate in 
clinical trials on the lens that is subject to the PMA holders application, the protocol 
should require that each finishing laboratory prepare at least 10 lenses from at least 10 
different prescriptions provided by the PMA holder, who will inspect the lenses to 
determine whether they meet the final product criteria of the lenses covered by the 
approved PMA.  The protocol should be approved by FDA before it is used to evaluate 
laboratories to ensure that FDA will accept the inspection results.  The protocol should 
include procedures whereby the PMA holder will verify that each lens finishing 
laboratory is in compliance with the sponsors standard operating procedures and FDAs 
Good Manufacturing Requirements, as set forth in the Quality System Regulation for
medical devices,  and that finished lenses sampled in accordance with the inspection 
sampling plan comply with the PMA holders approved lens specifications with respect 
to design, labeling dimensions, powers, surface finish, edge finish, and sterility. 
3. A monitoring plan for continued surveillance over each finishing laboratory to monitor 
audit procedures and ensure continued conformance of lenses to the approved 
specifications. Page 6 - All Class III Rigid Gas Permeable Contact Lens PMA Holders and Interested Persons
4. A plan for an adverse reaction reporting system to be established and maintained by the 
PMA holder, encompassing all approved finishing laboratories and meeting all provisions 
of the Adverse Reaction and Device Defect Reporting and the Reporting Under the 
Medical Device Reporting (MDR) Regulations section of the Conditions of Approval 
for PMAs, dated  March 4, 1998 (copy attached).  The lens finishing laboratories must 
report any adverse reactions to the PMA holder within 10 days of becoming aware of 
such reactions.
5. Two suitably worded sworn declarations; one declaration to be completed and signed by a
responsible official from each lens finishing laboratory stating that, once the laboratory 
begins manufacturing the lenses, the laboratory will comply with (a) the PMA holders  
approved manufacturing process, (b) all requirements of the Federal Food, Drug, and 
Cosmetic Act, (c) the PMA approval order, and (d) this document; and a second 
declaration to be completed and signed by the PMA holder verifying that the lens 
laboratory has been evaluated in accordance with, and found to conform to, all provisions 
of the protocol described in item 2, page 5.
After approval of the PMA or PMA supplement containing the documentation specified above,
and after the PMA holder has documented that the lens finishing laboratories have been found to
have met all evaluation criteria and the declarations described in item 5, page 6, have been signed
and placed in the PMA holders device master records, the lens finishing laboratories may begin
manufacturing and distributing the approved RGP contact lenses. 
Documentation:
After obtaining approval for a PMA or PMA supplement containing a protocol for additional
finishing laboratories, the PMA holder may provide for additional finishing laboratories to
manufacture and distribute the approved RGP lenses by following the procedures in this
document and documenting the following information in the next annual report to FDA and the
firms device master records and complaint files to be made available to FDA upon request:
1. Annual Report
a) Copy of the PMA holders agreement to comply with the procedures in this
document.
b) The PMA or PMA supplement number that contains the approved protocol for
adding additional finishing laboratories as manufactures and distributors of RGP
lenses. Page 7 - All Class III Rigid Gas Permeable Contact Lens PMA Holders and Interested Persons
c)  The first annual report submitted after implementation of these revised procedures
should include a complete listing of names, addresses, and responsible persons for
all finishing laboratories approved under each PMA.  Future annual reports should 
            include additional finishing laboratories added since the last annual report was 
            submitted, as well as those previously approved laboratories that are no longer 
             participating.
d)  Copies of two sworn declarations (finishing laboratory and PMA holder) in
accordance with item 5, page 6.
2.  Device Master Records
a)  Copy of the PMA holders agreement to comply with the procedures in this
document.
b)  The PMA or PMA supplement number that contains the approved protocol for
adding additional finishing laboratories as manufactures and distributors of RGP
lenses.
c)  Copies of all documentation provided to lens finishing laboratories as listed in 
items 1-3(a-i), pages 4 and 5.
d)  Copies of the approved protocol and PMA holders evaluation demonstrating that 
each lens finishing laboratory has been evaluated and found to comply with all 
elements in the approved protocol, as listed in item 2, page 5.
e)  Copy of the monitoring plan used for continued surveillance over each finishing 
laboratory to monitor audit procedures and ensure continued conformance of 
lenses to the approved specifications, as listed in item 3, page 5, along with a
record of surveillance over each laboratory 
f)  Copy of the PMA holders plan for Adverse Reaction and Device Defect 
Reporting and Reporting Under the Medical Device Reporting (MDR) 
Regulations section of the Conditions of Approval for PMAs dated March 4, 
1998, as listed in item 4, page 6.  All adverse reactions associated with use of the 
approved RGP lens should be documented in the PMA holders complaint files.
g)  Copies of two sworn declarations (finishing laboratory and PMA holder) in 
accordance with item 5, page 6. Page 8 - All Class III Rigid Gas Permeable Contact Lens PMA Holders and Interested Persons
h)    The names, addresses, and names and titles of persons at each finishing laboratory 
responsible for compliance with these procedures; the private label brand name, if 
applicable; date on which the addition of lens finishing laboratory was 
implemented; and any change in the above items.
3.  Complaint Files
All complaints associated with the device, including adverse reactions described in
item 2(f).
Effective Date:  The above procedures are effective as of date of issuance.
If you have any questions, please contact James F. Saviola, O.D., at (301) 594-1744.
                                                                            Sincerely yours,
                                                                            A. Ralph Rosenthal,  M.D.
                                                                            Director
                                                                            Division of Ophthalmic Devices                        
                                                                            Office of Device Evaluation
                                                                            Center for Devices and
                                                                                 Radiological Health
Attachment (Conditions of Approval Dated March 4, 1998) GCOA
Issued: 3-4-98
CONDITIONS OF APPROVAL
APPROVED LABELING.  As soon as possible, and before commercial distribution of
your device, submit three copies of an amendment to this PMA submission with
copies of all approved labeling in final printed form to the PMA Document Mail
Center (HFZ-401), Center for Devices and Radiological Health, Food and Drug
Administration (FDA), 9200 Corporate Blvd., Rockville, Maryland  20850.
ADVERTISEMENT.  No advertisement or other descriptive printed material issued
by the applicant or private label distributor with respect to this device
shall recommend or imply that the device may be used for any use that is not
included in the FDA approved labeling for the device.  If the FDA approval
order has restricted the sale, distribution and use of the device to
prescription use in accordance with 21 CFR 801.109 and specified that this
restriction is being imposed in accordance with the provisions of section
520(e) of the act under the authority of section 515(d)(1)(B)(ii) of the act,
all advertisements and other descriptive printed material issued by the
applicant or distributor with respect to the device shall include a brief
statement of the intended uses of the device and relevant warnings,
precautions, side effects and contraindications.
PREMARKET APPROVAL APPLICATION (PMA) SUPPLEMENT.  Before making any change
affecting the safety or effectiveness of the device, submit a PMA supplement
for review and approval by FDA unless the change is of a type for which a
"Special PMA Supplement-Changes Being Effected" is permitted under 21 CFR
814.39(d) or an alternate submission is permitted in accordance with 21 CFR
814.39(e).  A PMA supplement or alternate submission shall comply with
applicable requirements under 21 CFR 814.39 of the final rule for Premarket
Approval of Medical Devices.
All situations which require a PMA supplement cannot be briefly summarized,
please consult the PMA regulation for further guidance.  The guidance provided
below is only for several key instances.
A PMA supplement must be submitted when unanticipated adverse effects,
increases in the incidence of anticipated adverse effects, or device failures
necessitate a labeling, manufacturing, or device modification.
A PMA supplement must be submitted if the device is to be modified and the
modified device should be subjected to animal or laboratory or clinical
testing designed to determine if the modified device remains safe and
effective.
A "Special PMA Supplement - Changes Being Effected" is limited to the
labeling, quality control and manufacturing process changes specified under 21
CFR 814.39(d)(2).  It allows for the addition of, but not the replacement of
previously approved, quality control specifications and test methods.  These
changes may be implemented before FDA approval upon acknowledgment by FDA that
the submission is being processed as a "Special PMA Supplement - Changes Being
Effected."  This acknowledgment is in addition to that issued by the PMA
Document Mail Center for all PMA supplements submitted.  This procedure is not
applicable to changes in device design, composition, specifications,
circuitry, software or energy source. Alternate submissions permitted under 21 CFR 814.39(e) apply to changes that
otherwise require approval of a PMA supplement before implementation of the
change and include the use of a 30-day PMA supplement or annual postapproval
report.  FDA must have previously indicated in an advisory opinion to the
affected industry or in correspondence with the applicant that the alternate
submission is permitted for the change.  Before such can occur, FDA and the
PMA applicant(s) involved must agree upon any needed testing protocol, test
results, reporting format, information to be reported, and the alternate
submission to be used.
POSTAPPROVAL REPORTS.  Continued approval of this PMA is contingent upon the
submission of postapproval reports required under 21 CFR 814.84 at intervals
of 1 year from the date of approval of the original PMA.  Postapproval reports
for supplements approved under the original PMA, if applicable, are to be
included in the next and subsequent annual reports for the original PMA unless
specified otherwise in the approval order for the PMA supplement.  Two copies
identified as "Annual Report" and bearing the applicable PMA reference number
are to be submitted to the PMA Document Mail Center (HFZ-401), Center for
Devices and Radiological Health, Food and Drug Administration, 9200 Corporate
Blvd., Rockville, Maryland  20850.  The postapproval report shall indicate the
beginning and ending date of the period covered by the report and shall
include the following information required by 21 CFR 814.84:
(1)Identification of changes described in 21 CFR 814.39(a) and changes
required to be reported to FDA under 21 CFR 814.39(b).
(2) Bibliography and summary of the following information not previously
submitted as part of the PMA and that is known to or reasonably should be
known to the applicant:
(a)unpublished reports of data from any clinical investigations or
nonclinical laboratory studies involving the device or related devices
("related" devices include devices which are the same or substantially
similar to the applicant's device); and
(b)reports in the scientific literature concerning the device.
If, after reviewing the bibliography and summary, FDA concludes that agency
review of one or more of the above reports is required, the applicant shall
submit two copies of each identified report when so notified by FDA.
ADVERSE REACTION AND DEVICE DEFECT REPORTING.  As provided by 21 CFR
814.82(a)(9), FDA has determined that in order to provide continued reasonable
assurance of the safety and effectiveness of the device, the applicant shall
submit 3 copies of a written report identified, as applicable, as an "Adverse
Reaction Report" or "Device Defect Report" to the PMA Document Mail Center
(HFZ-401), Center for Devices and Radiological Health, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, Maryland  20850 within 10
days after the applicant receives or has knowledge of information concerning:
(1)A mix-up of the device or its labeling with another article.
(2)Any adverse reaction, side effect, injury, toxicity, or sensitivity
reaction that is attributable to the device and
(a)has not been addressed by the device's labeling or
(b)has been addressed by the device's labeling, but is occurring with
unexpected severity or frequency. (3)Any significant chemical, physical or other change or deterioration in the
device or any failure of the device to meet the specifications established in
the approved PMA that could not cause or contribute to death or serious injury
but are not correctable by adjustments or other maintenance procedures
described in the approved labeling.  The report shall include a discussion of
the applicant's assessment of the change, deterioration or failure and any
proposed or implemented corrective action by the applicant.  When such events
are correctable by adjustments or other maintenance procedures described in
the approved labeling, all such events known to the applicant shall be
included in the Annual Report described under "Postapproval Reports" above
unless specified otherwise in the conditions of approval to this PMA.  This
postapproval report shall appropriately categorize these events and include
the number of reported and otherwise known instances of each category during
the reporting period.  Additional information regarding the events discussed
above shall be submitted by the applicant when determined by FDA to be
necessary to provide continued reasonable assurance of the safety and
effectiveness of the device for its intended use.
REPORTING UNDER THE MEDICAL DEVICE REPORTING (MDR) REGULATION.  The Medical
Device Reporting (MDR) Regulation became effective on December 13, 1984.  This
regulation was replaced by the reporting requirements of the Safe Medical
Devices Act of 1990 which became effective July 31, 1996 and requires that all
manufacturers and importers of medical devices, including in vitro diagnostic
devices, report to the FDA whenever they receive or otherwise become aware of
information, from any source, that reasonably suggests that a device marketed
by the manufacturer or importer:
(1)May have caused or contributed to a death or serious injury; or
(2)Has malfunctioned and such device or similar device marketed by the 
   manufacturer or importer would be likely to cause or contribute to a
   death or serious injury if the malfunction were to recur.
The same events subject to reporting under the MDR Regulation may also be
subject to the above "Adverse Reaction and Device Defect Reporting"
requirements in the "Conditions of Approval" for this PMA.  FDA has determined
that such duplicative reporting is unnecessary.  Whenever an event involving a
device is subject to reporting under both the MDR Regulation and the
"Conditions of Approval" for a PMA, the manufacturer shall submit the
appropriate reports required by the MDR Regulation within the time frames as
identified in 21 CFR 803.10(c) using FDA Form 3500A, i.e., 30 days after
becoming aware of a reportable death, serious injury, or malfunction as
described in 21 CFR 803.50 and 21 CFR 803.52 and 5 days after becoming aware
that a reportable MDR event requires remedial action to prevent an
unreasonable risk of substantial harm to the public health.  The manufacturer
is responsible for submitting a baseline report on FDA Form 3417 for a device
when the device model is first reported under 21 CFR 803.50.  This baseline
report is to include the PMA reference number.  Any written report and its
envelope is to be specifically identified, e.g., Manufacturer Report, 5-Day
Report, Baseline Report, etc.  Any written report is to be submitted to:
Food and Drug Administration
Center for Devices and Radiological Health
Medical Device Reporting
PO Box 3002
Rockville, Maryland  20847-3002 Copies of the MDR Regulation (FOD # 336&1336)and FDA publications entitled An
Overview of the Medical Device Reporting Regulation (FOD # 509) and Medical
Device Reporting for Manufacturers (FOD #987) are available on the CDRH WWW
Home Page.  They are also available through CDRHs Fact-On-Demand (F-O-D) at
800-899-0381.  Written requests for information can be made by sending a
facsimile to CDRHs Division of Small Manufacturers Assistance (DSMA) at 301-
443-8818.