[Federal Register Volume 61, Number 71 (Thursday, April 11, 1996)]
[Rules and Regulations]
[Pages 16043-16045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8970]



Food and Drug Administration

21 CFR Parts 803 and 807

[Docket No. 91N-0295]
RIN 0910-AA09

Medical Devices; Medical Device User Facility and Manufacturer 
Reporting, Certification and Registration; Office of Management and 
Budget Approval; Extension of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; notification of approval of information collection 


SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
Office of Management and Budget (OMB) has approved the collection of 
information requirements in the final rule on medical device user 
facility and manufacturer reporting, certification and registration. In 
addition, FDA is extending to July 31, 1996, the effective date of the 
final rule in response to requests and in order to allow sufficient 
time for user facilities and manufacturers to implement procedures to 
comply with the final rule. The final rule was published in the Federal 
Register of December 11, 1995 (60 FR 63578).

EFFECTIVE DATE: July 31, 1996.

FOR FURTHER INFORMATION CONTACT: Earl W. Robinson, Center for Devices 
and Radiological Health (HFZ-530), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-594-2735.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 11, 1995

[[Page 16044]]
(60 FR 63578), FDA published a final rule (21 CFR parts 803 and 807) 
requiring medical device user facilities and manufacturers to report 
adverse events related to medical devices under a uniform reporting 
system. In the preamble to the final rule (60 FR 63578 at 63596), FDA 
announced that the collection of information requirements contained in 
the final rule had been submitted to OMB for approval under the 
Paperwork Reduction Act of 1995 (Pub. L. 104-13). The agency also 
requested public comment on the information collection requirements by 
January 10, 1996. The agency further stated that these collection of 
information requirements would not become effective until FDA obtained 
OMB approval of them, and that FDA would publish in the Federal 
Register a notice of OMB's decision to approve, modify, or disapprove 
    FDA received 26 comments regarding the information collection 
requirements. Comments were reviewed by both FDA and OMB. On February 
23, 1996, OMB sent FDA a notice of action stating that the collection 
of information requirements are approved for use through February 28, 
1999, under OMB control number 0910-0059. Persons are not required to 
respond to a collection of information unless it displays a currently 
valid OMB control number.
    In response to comments to the information collection requirements, 
FDA is changing the effective date of the final rule and providing 
certain clarifications and guidance regarding requirements of the final 
    1. Several comments requested that the date of the final rule be 
extended to allow manufacturers and user facilities additional time to 
set up procedures to implement the new requirements. These comments 
stated that the effective date of the final rule, April 11, 1996, would 
not allow them enough time after approval of the forms to set up 
reporting procedures, databases, and train personnel. FDA agrees that 
reporting entities need additional time to set up reporting procedures. 
FDA, on the basis of these comments on the information collection, is 
extending that comment period to July 31, 1996, without further notice 
and comment procedures.
    The Administrative Procedure Act and FDA regulations provide that 
the agency may issue a regulation without notice and comment procedures 
when the agency for good cause finds (and incorporates the finding and 
a brief statement of reasons thereof in the rules issued) that notice 
and public procedure thereon are impracticable, unnecessary, or 
contrary to the public interest (5 U.S.C. 553(b)(8); 21 CFR 
10.40(e)(1)). FDA finds that there is good cause for dispensing with 
notice and comment procedures to extend the effective date of the final 
rule because such procedures are impracticable, unnecessary, and 
contrary to the public interest.
    First, notice and comment rulemaking on the extension of the 
effective date is impracticable. FDA was unable to prepare and issue 
notice of the extension of the effective date until April 11, 1996. 
Because the final rule's effective date is April 11, 1996, there is not 
enough time for FDA to solicit a new round of notice and comment before 
the effective date. Although the final rule informing reporting 
entities of the new requirements was published on December 11, 1995, 
reporters have not known what forms would be required until the 
issuance of this notice. Without the forms, reporting entities have 
heretofore been unable to set up their reporting procedures and 
databases or train personnel. Adequate procedures and training will 
ensure that reporters generate reports that contain meaningful 
information that will allow FDA efficiently evaluate adverse events. 
FDA believes that reporting entities need until July 31, 1996, to set 
up adequate procedures to implement the new reporting requirements.
    Second, engaging in notice and comment rulemaking is unnecessary. 
The public has already had two separate opportunities to comment on the 
effective date; the first in response to the request in the tentative 
final rule for comments, and the second in response to the request in 
the request in the final rule for comments relating to the information 
collection requirements. All of the comments FDA has received are in 
favor of extending the effective date to allow reporters adequate time 
to set up procedures to implement the new regulations. FDA does not 
believe another round of notice and comment is necessary on an issue 
that has already received two rounds of public comment.
    Third, notice and comment rulemaking is contrary to the public 
interest. Extending the effective date of the rule without notice and 
comment allows reporters immediate certainty as to the timeframes that 
they have to set up procedures to implement the new reporting 
requirements. If FDA did not provide a definite effective date, 
reporters may bear additional expense and hardship in setting up 
inefficient interim procedures in order to be ready to report on a 
certain date, when that date may ultimately be extended. Moreover, 
because reports generated under interim procedures would be processed 
without adequate time to implement proper training and procedures, such 
reports may be of poor quality that would preclude both reporters and 
FDA from obtaining information to evaluate adverse events effectively. 
Certain knowledge of the date the regulation will be effective will 
allow reporters to know the exact timeframe that will allow them to 
implement procedures to effectively evaluate and submit reports.
    For all the reasons stated above, FDA concludes, under 5 U.S.C. 
553(b)(B) and 21 CFR 10.40(e)(1), there is good cause for extending the 
effective date of the final rule without notice and comment procedures. 
Consistent with its own procedural regulations, however, FDA is 
providing an opportunity for comment on its decision to delay the 
effective date of the final regulation until July 31, 1996.
    2. Several comments stated that FDA should reconsider requiring a 
baseline report (FDA Form 3417) for each model number because reporters 
would have to submit many separate baseline reports for virtually 
identical devices that have option and accessory packages that are 
identified by a model number variation, such as a prefix or suffix.
    Section 803.55 requires that a manufacturer shall submit a baseline 
report for a device when the device model is first reported under 
Sec. 803.50. The regulation does not require a baseline report for 
every model number variation. FDA does not believe that the regulation 
requires a separate baseline report for every model number variation, 
if the variation could not affect the device's safety or effectiveness. 
If a manufacturer groups model numbers, it should list each model 
number variation on the baseline report that is included (e.g., basic 
model number 900; model number variations, R900, 900C, 900D, and 
R900C). FDA will match the variations of the model number reported on 
form 3500A to the list of model numbers provided on the baseline 
    3. Comments requested further clarification on the definition of 
``device family'' (Sec. 803.3(e)) that is used to identify similar 
groups of devices on the manufacturer baseline report. FDA classified 
and revised Sec. 803.3(e) to define ``device family'' as devices that 
have the same basic design and performance characteristics related to 
safety and effectiveness, intended use and function, and device 
classification and product code. Devices that differ only in minor ways 
not related to safety or effectiveness can be considered to be in the 
same device family. Factors such as brand name and common name of the 
device and whether the devices were

[[Page 16045]]
introduced into commercial distribution under the same 510(k) or 
premarket approval application, may be considered in grouping products 
into device families.As part of implementation of the final regulation, 
FDA will provide further information, guidance and examples.
    4. Comments objected to the requirement on the annual certification 
form for manufacturers (FDA Form 3381) that the firm certify not only 
the number of reports submitted during the 12-month period for which 
the certification is submitted, but also that this number constitutes 
all the reportable events for which the firm is responsible during that 
    FDA responded to similar comments in the preamble to the final rule 
(60 FR 63578 at 63591). For the reasons stated therein, FDA still 
believes that it is necessary and within FDA's statutory authority to 
require that manufacturers certify that they have submitted all 
reportable events to FDA. FDA believes that certification is an 
important means of increasing the effectiveness of the Medical Device 
Reporting (MDR) system. FDA, however, realizes that there may be 
situations, hopefully rare, when a manufacturer, for example, did not 
``become aware,'' as defined in 803.1(c) (21 CFR 803.1(c)), of 
information reasonably suggesting a reportable event has occurred, and 
therefore could not have submitted a report, or there may be an 
occasional instance of miscounting the number of reports. FDA, 
therefore, has determined that it is appropriate for manufacturers to 
state that they are certifying the statements on FDA Form 3381 to the 
best of their knowledge. FDA has revised the form accordingly. It now 
    I certify that, to the best of my knowledge, the firms listed in 
item 3. above either submitted the MDR indicated above during the 
stated reporting period and that this number represents the 
submissions for all appropriately reportable MDR events or that the 
firm listed above did not receive any MDR reportable events during 
this time period. I also certify that, to the best of my knowledge, 
the statements and information presented in this submission are 
truthful and accurate.
    5. Comments objected to the requirement that annual updates to 
baseline reports be submitted on the anniversary date of the initial 
baseline report. The comments noted that, for companies who submit 
baseline reports for numerous devices, they would have to keep track of 
many different submission dates for update baseline reports. The 
comments suggested that manufacturers be allowed to submit all baseline 
updates on a single date, e.g., the date on which annual certification 
is required.
    FDA agrees with the comments and believes that it is an acceptable 
interpretation of the regulation to allow an annual update on the date 
on which the annual certification is due.
    Section 803.55(a) requires that a manufacturer shall submit its 
first baseline report ``for a device when the device model is first 
reported under Sec. 803.50'' (i.e., an individual adverse event 
report). Section 803.55(b) requires that each baseline report shall be 
updated annually, on the anniversary month of the initial submission. 
The time a manufacturer is required to submit the update of their 
baseline report under Sec. 803.55(b), is therefore contingent upon the 
time a manufacturer is considered to have ``first reported'' an adverse 
event for a particular device model.
    FDA believes that a manufacturer could interpret Sec. 803.55(a) to 
mean that the first baseline report update could be submitted on the 
date a firm is required to submit its next certification. Accordingly, 
the firm could thereafter submit its annual baseline update report on 
the date of the firm's next annual certification. For example, if a 
manufacturer submits its first adverse event baseline report for a 
device on March 1, 1996, it could submit its first baseline report on 
the date of its next certification report, November 1, 1996. 
Thereafter, it would submit its update baseline report on November 1, 
    FDA intends to make a guidance document on the final rule available 
during April 1996, and will announce it's availability in the Federal 
Register. FDA also intends to hold a nationwide teleconference by 
satellite on May 7, 1996, during which FDA officials will speak on the 
final rule and be available to answer questions. When more details are 
available, FDA will publicize these initiatives through the Facts-on-
Demand system administered by FDA's Division of Small Manufacturers 
Assistance, Center for Devices and Radiological Health, and the 
electronic docket. To access this information through Facts-on-Demand 
dial 1-800-899-0381 (outside MD) or 1-301-827-0111 (inside MD) and 
enter document number 799.

    Dated: March 30, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-8970 Filed 4-5-96; 3:26 pm]