Download:
pdf |
pdfDEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Medical Device De Novo Classification Process;
Final Rule
Docket No. FDA-2018-N-0236
Final Regulatory Impact Analysis
Final Regulatory Flexibility Analysis
Unfunded Mandates Reform Act Analysis
Economics Staff
Office of Economics and Analysis
Office of Policy, Legislation, and International Affairs
Office of the Commissioner
Table of Contents
I. Introduction and Summary _____________________________________________ 3
A. Introduction ______________________________________________________________ 3
B. Summary of Costs and Benefits ______________________________________________ 4
C. Comments on the Preliminary RIA and Our Responses ____________________________ 6
D. Summary of Changes _______________________________________________________ 7
II. Final Regulatory Impact Analysis ________________________________________ 8
A. Background ______________________________________________________________ 8
B. Market Failure Requiring Federal Regulatory Action _____________________________ 9
C. Baseline Conditions _______________________________________________________ 10
D. Benefits of the Rule _______________________________________________________ 10
1. Fewer Incomplete or Poor-Quality De Novo Request Submissions ________________________ 11
2. Faster Introduction of Medical Devices and Increased Medical Device Variety ______________ 12
E. Costs of the Rule _________________________________________________________ 13
F. Summary of the Impacts of the Rule__________________________________________ 15
G.
International Effects ____________________________________________________ 16
H. Uncertainty and Sensitivity Analysis _________________________________________ 16
I. Analysis of Regulatory Alternatives to the Rule _________________________________ 17
III. Final Small Entity Analysis ____________________________________________ 17
IV. References _________________________________________________________ 18
2
I. Introduction and Summary
A. Introduction
We have examined the impacts of the final rule under Executive Order 12866, Executive
Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all
costs and benefits of available regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts; and equity). We believe that
this final rule is a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would
minimize any significant impact of a rule on small entities. Because small entities affected by
this final rule would incur very small one-time costs to read and understand the rule, we certify
that the final rule will not have a significant economic impact on a substantial number of small
entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a
written statement, which includes an assessment of anticipated costs and benefits, before
proposing "any rule that includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or
more (adjusted annually for inflation) in any one year." The current threshold after adjustment
for inflation is $158 million, using the most current (2020) Implicit Price Deflator for the Gross
Domestic Product. This final rule would not result in an expenditure in any year that meets or
exceeds this amount.
3
B. Summary of Costs and Benefits
The final rule will clarify the De Novo classification process for certain medical devices
to obtain marketing authorization as class I or class II devices, rather than remaining
automatically designated as class III devices under the Federal Food, Drug, and Cosmetic
(FD&C) Act. In addition, the final rule will clarify and create a more efficient De Novo
classification process by specifying: (1) what medical devices are eligible for the De Novo
classification process; (2) what information manufacturers must provide in De Novo requests;
and (3) how to organize this information. By clarifying and making the process more efficient,
the final rule could reduce the time and costs associated with reviewing De Novo requests.
Moreover, the final rule will allow us to refuse to accept inappropriate and deficient De Novo
requests and require us to protect the confidentiality of certain data and information submitted
with a request until we issue an order granting the request.
Industry will incur costs to read and understand this final rule. The present discounted
value over 10 years ranges from $0.06 million to $1.1 million, with a primary estimate of $0.6
million at a 7 percent discount rate. The present discounted value of these costs over 10 years
ranges from $0.06 million to $1.1 million, with a primary estimate of $0.6 million at a 3 percent
discount rate.
Table 1 summarizes our estimate of the annualized costs and the annualized benefits of
the final rule over 10 years. We estimate that the annualized costs over 10 years would range
from $0.01 million to $0.17 million at a 7 percent discount rate, with a primary estimate of $0.09
million. We estimate that the annualized costs over 10 years at a 3 percent discount rate would
range from $0.01 million to $0.15 million, with a primary estimate of $0.08 million.
Table 1. Summary of Benefits, Costs and Distributional Effects of the Final Rule ($ Millions)
4
Category
Primary
Low
High
Estimate Estimate Estimate
Annualized
Monetized
$millions/year
Annualized
Quantified
Units
Year Discount Period
Dollars
Rate
Covered
2019
7%
2019
3%
2019
2019
7%
3%
Qualitative
10
years
10
years
10
years
10
years
Benefits
Annualized
Monetized
$millions/year
Costs
$0.09
$0.01
$0.17
2019
$0.08
$0.01
$0.15
2019
Annualized
Quantified
2019
2019
Qualitative
Federal
Annualized
Monetized
$millions/year
Transfers
5
Other
Annualized
Monetized
$millions/year
2019
2019
From:
From:
7%
3%
7%
3%
7%
3%
To:
2019
7%
2019
3%
To:
10
years
10
years
10
years
10
years
10
years
10
years
10
years
10
years
Notes
Clarification of
the De Novo
process for
requesters.
Potentially
fewer
incomplete
submissions and
faster
introduction of
medical
devices.
Category
Effects
Primary
Low
High
Estimate Estimate Estimate
Units
Year Discount Period
Dollars
Rate
Covered
Notes
State, Local or Tribal Government: None
Small Business: A small one-time administrative burden of up to $300 on each affected small
entity.
Wages: None
Growth: None
C. Comments on the Preliminary RIA and Our Responses
We received several sets of comments on the proposed rule (Ref. 1) by the close of the
comment period, each containing one or more comments on one or more issues. We received
comments from medical device associations, industry, medical and health care professional
associations, public health advocacy groups, law firms, and individuals. None of the comments
referenced the preliminary regulatory impact analysis (Ref. 2) specifically, although some
comments generally discussed potential burdens of the proposed rule.
(Comment 1) A comment supported facility inspection prior to granting or declining a De
Novo request because the commenter states it is essential for safety in the case of novel medical
devices. Several commenters wanted to remove or revise the subsection related to facility
inspections because the commenters state the provision is unduly burdensome.
(Response 1) FDA disagrees with the comments to remove facility inspections and is
finalizing this provision with clarifying changes. The inspection would be done only in the two
circumstances specified in the regulation and described in the Preamble in Section V.E. Because
we already conduct inspections related to De Novo requests under these circumstances, these
inspections are part of our baseline.
6
(Comment 2) A few commenters state it is unnecessary and places a potentially
unrealistic burden on the De Novo requester to provide a “complete” device description.
(Response 2) We disagree with these comments. We do not expect an excessively
detailed description of the device, but there must be sufficient detail to describe the aspects of the
device that could affect safety and effectiveness. A complete device description is necessary for
us to classify a device. The word “complete” is not overly burdensome.
(Comment 3) Some comments request we eliminate the language indicating that the
Agency may “test” one or more of the devices because we have traditionally relied on testing by
the manufacturer. Another commenter indicated that while providing samples may be
appropriate for a high-risk device likely to be reviewed in a PMA, it is unclear that samples are
necessary for devices reviewed through the De Novo pathway.
(Response 3) We disagree with these comments because there are some situations in
which we may need to see or test a device reviewed through the De Novo pathway to understand
the device and determine if general or general and special controls are sufficient to reasonably
assure safety and effectiveness of the device and device type. Commenters did not provide
enough information for us to add a cost related to the requirement for samples.
D. Summary of Changes
The final rule is similar to the proposed rule. However, we are making some changes to
the regulatory text in response to comments, including eliminating certain sections, changing the
ordering of certain requirements, and making other edits for clarity. In addition, on our own
initiative, we are renumbering the sections to make them easier for De Novo requesters and the
public to use and making other clarifying and technical changes. None of these changes affect
7
the analysis of the costs of this rule, although we have revised this analysis to reflect updated
wages. We have moved the discussion of the costs to read and understand the rule that appeared
in the uncertainty section of the preliminary regulatory impact analysis to the main analysis in
this document.
In the preliminary regulatory impact analysis, we included a discussion of the potential
benefits of this rule from reducing the number of unnecessary premarket notifications (510(k)s)
that we receive prior to receiving a De Novo request. We have no data to suggest that we are still
receiving unnecessary 510(k)s; therefore, we do not consider any potential cost-savings to
industry or us from fewer unnecessary 510(k) submissions. We have removed that discussion
from this analysis.
II. Final Regulatory Impact Analysis
A. Background
The Food and Drug Administration Modernization Act of 1997 (FDAMA) provided FDA
with the authority for the De Novo classification process. The Food and Drug Administration
Safety and Innovation Act of 2012 (FDASIA) modified the De Novo classification process to
remove the requirement that manufacturers provide evidence that their device was not
substantially equivalent (NSE) to a predicate device. Prior to FDASIA, manufacturers would
submit a 510(k) to us to receive a determination that their device was NSE, and then submit a De
Novo request. FDASIA eliminated the need for manufacturers to submit a 510(k) before
submitting a De Novo request. When no legally marketed device upon which to base a
determination of substantial equivalence exists, manufacturers can submit a De Novo request
without first receiving an NSE determination on a 510(k). In 2016, the 21st Century Cures Act
8
further modified the De Novo classification process to remove the 30-day requirement to submit
a De Novo request when a medical device manufacturer receives an NSE determination.
The De Novo classification process was meant to reduce the costs of marketing certain
“novel” medical devices statutorily classified into class III, even though the medical devices may
meet the statutory definition of a class I or class II device. On October 30, 2017, FDA issued a
final guidance to provide recommendations on the process for the submission and review of a De
Novo request. The guidance provides recommendations for interactions with FDA related to the
De Novo classification process, including what information to submit when seeking a path to
market via the De Novo classification process. Although we expect this guidance would help the
medical device industry better understand the De Novo classification process, our program
experience suggests that we need a regulation to refuse deficient De Novo requests and to
provide additional assurance to requesters of the confidentiality of the data and other information
in a De Novo request. The final rule will encourage device manufacturers to use the De Novo
classification pathway as intended by statute.
B. Market Failure Requiring Federal Regulatory Action
FDAMA gave us the authority to classify certain novel devices under the De Novo
classification process. FDASIA removed the requirement that device manufacturers first obtain
an NSE determination for a novel device to submit a De Novo request. In 2016, the 21st Century
Cures Act further modified the De Novo classification process to remove the 30-day requirement
to submit a De Novo request when a medical device manufacturer receives an NSE
determination. Although we have issued guidance to industry about our current interpretation of
statutes related to the De Novo classification process, we created an institutional failure by not
9
issuing rulemaking to provide sufficient information to industry about the requirements for the
De Novo classification process. The market cannot self-correct without us issuing a final rule.
The final rule will provide the medical device industry with sufficient information about
the regulatory requirements of the De Novo classification process for certain novel devices and
would provide FDA with the authority to refuse deficient De Novo requests, creating an
incentive to comply with the requirements of the process. The final rule also explicitly protects
the confidentiality of the data and other information prior to granting the De Novo request, which
creates greater assurance that submitting data and other information would not prematurely
jeopardize any market advantage. Not understanding the De Novo classification process, or
perhaps not trusting the process to protect their data and other information, might lead some in
the industry not to use the De Novo process.
C. Baseline Conditions
We have been receiving De Novo submissions for many years. Therefore, we use the
state of the world without this rule, where we would continue to receive De Novo submissions,
as our baseline. We received 339 De Novo submissions from fiscal year 2016 to fiscal year 2020,
with an average of around 68 De Novo submissions each year.
D. Benefits of the Rule
The final rule will more fully describe the data and other information required for De
Novo requests, which should result in higher quality requests. The final rule will also allow us to
refuse to accept inappropriate or deficient De Novo requests. Thus, the rule would reduce the
time that we spend reviewing and responding to requests. Reducing the review times and
providing clarification regarding the content of a De Novo request should encourage
10
manufacturers to introduce their novel devices into the marketplace sooner, which should
increase their profitability and consumer satisfaction, and promote the introduction of more
medical devices. As more devices obtain marketing authorization via the De Novo classification
process, we anticipate that medical device variety would increase, and over time, incrementally
lower health costs.
1. Fewer Incomplete or Poor-Quality De Novo Request Submissions
The final rule will generate benefits by reducing the effort medical device manufacturers
spend preparing De Novo requests, and the time we spend reviewing and processing such
requests. Below we describe qualitatively these potential benefits.
a. Better Quality De Novo Requests
The final rule will provide the medical device industry with more complete and more
detailed instructions about the De Novo classification process. We expect that better information
would also reduce the time that our scientists spend reviewing De Novo requests because most
requests would contain all the necessary materials for us to start a formal review, including only
required data from sources that meet our standards. However, we lack sufficient data to estimate
how industry will respond to the final rule.
b. Fewer Incomplete De Novo Requests
We expect the final rule will reduce the number of incomplete De Novo requests because
we would have the authority to refuse to accept requests that do not include all elements needed
for FDA to begin its substantive review. Our experience shows that the two most common
11
reasons for incomplete De Novo requests are missing materials and materials that do not support
a request. For De Novo requests with missing materials, we must spend time to communicate
what materials should have been included in the request. For De Novo requests containing
unnecessary information, we would spend more time than needed to review and then re-review
materials provided to support the requests. However, we lack data to quantify these potential
benefits.
2. Faster Introduction of Medical Devices and Increased Medical Device Variety
By more fully specifying the requirements for De Novo requests, we expect industry to
more quickly introduce their novel medical devices to the U.S. market. With clearer regulatory
requirements, we anticipate that industry will benefit from the profit from the additional time
their products are commercially available. We also expect consumers will benefit because the
products will potentially reach the U.S. market sooner. Reduced time and cost from shorter
reviews should also encourage more device manufacturers to use the De Novo classification
process, which could lead to a greater variety of medical device for U.S. consumers over time.
Economists call these benefits to producers and consumers, producer surplus and consumer
surplus. The social cost of the regulatory burden includes the losses associated with products not
being marketed or being marketed with a delay.
Although the economic theory is clear, we lack data for the number of individuals that
use the medical devices brought to market under the De Novo classification pathway, the
willingness of consumers to pay for faster introduction of novel medical devices, and other data
to help us measure the gains from the faster introduction of these devices might generate. Recent
12
research indicates there is an increasing demand for medical device variety that would enable
patients to choose the treatments that best suit their tastes and preferences (Ref. 3). Although
consumers would likely be willing to pay for their additional satisfaction from greater variety,
we are not able to identify any studies estimating the willingness of consumers to pay for
increased medical device variety.
With fewer submission errors and more complete data there will be lower costs to
introduce novel devices to the U.S. market using the De Novo classification process, and we
expect to see an increase in medical device product variety. More product variety should
improve the ability of consumers to choose a treatment option that better addresses their health
condition, which we anticipate will also improve their consumer satisfaction.
E. Costs of the Rule
Reading and understanding the rule
We anticipate that medical device manufacturers that are likely to use the De Novo
classification process will incur costs to learn about the requirements of the rule. In 2017, about
17,000 domestic and foreign medical device manufacturers had registered with us. However, we
anticipate that most manufacturers will learn about the rule from trade organizations and from
our public communications. Some firms may choose to read the entire rule to fully understand
the changes to the De Novo classification process. To estimate the time to read and understand
the rule, Department of Health and Human Services (HHS) guidance (Ref. 4) recommends using
reading speeds of 200 words per minute to 250 words per minute. The final rule has
approximately 26,000 words. We estimate the time to learn about the requirements for
manufacturers that are likely to utilize the De Novo classification process would be between 1.73
13
hours (= 26,000 words / 250 words per minute / 60 minutes per hour) and 2.17 hours (= 26,000
words / 200 words per minute / 60 minutes per hour).
To estimate the cost of a manager’s time to read the rule, we use data on the median
hourly wage for a General and Operations Manager (occupation code 11-1021) in medical
equipment and supplies manufacturing (North American Industry Classification System code
339100). According to the Bureau of Labor Statistics’ National Occupational Employment and
Wage Estimates for 2019, the median wage for this occupation equals $61.98 per hour (Ref. 5).
To account for benefits and overhead, we double this value to $123.96 per hour (= $61.98 x 2).
Thus, for affected medical device manufacturers who would likely submit a De Novo request,
the per firm one-time cost to read and understand the rule ranges from $215 to $269.
To estimate the number of firms that might read the entire rule, we assume that every
future request comes from a different device manufacturer and that these manufacturers would
learn about the requirements at the time the rule publishes. Based on our experience with
previous submissions of De Novo requests, we assume that we might receive around 300 De
Novo requests from 300 unique firms over a 5-year period. We estimate that firms would incur a
one-time cost to learn about the rule between $64,459 (= 300 manufacturers x 1.73 hours per
manufacturer x $123.96 per hour) and $80,574 (= 300 manufacturers x 2.17 hours per
manufacturer x $123.96 per hour), with a primary estimate of $71,621 (= 300 manufacturers x
1.93 hours per manufacturer x $123.96 per hour). To capture the costs for device manufacturers
that are less likely to use the De Novo classification process, we assume each registered firm
would spend between 0 and 0.5 hours per manufacturer to understand the general requirements
of the rule. The one-time cost per firm would range from $0 to $61.98. The total one-time cost
for these manufacturers would range from $0 to $1,053,660 (= 17,000 manufacturers per year x
14
0.5 hour x $123.96 per hour), with a primary estimate of $526,830 (= 17,000 manufacturers per
year x 0.25 hour x $123.96 per hour). We estimate the total one-time cost for industry to learn
about the rule would range between $64,459 (= $64,459 + $0) and $1,134,234 (= $80,574 +
$1,053,660), with a primary estimate of $598,451 (= $71,621 + $526,830).
F. Summary of the Impacts of the Rule
The final rule will more clearly specify the requirements for De Novo requests, which
would reduce the likelihood that medical device manufacturers submit De Novo requests that are
costlier than necessary and reduce our current review times for De Novo requests. In Table 3, we
present our estimates of the quantified impacts of the rule. Over 10 years, the present value of the
costs range from $0.06 million to $1.1 million at a 7% discount rate, and from $0.06 million to
$1.1 million at a 3 percent discount rate. Our primary estimate of the present value of the costs
equals $0.6 million at both a 7 percent and 3 percent discount rate. The costs of the rule are the
same as the net costs because we have not quantified any cost-savings. Table 2 summarizes the
present value of costs and benefits, and Table 3 summarizes the annualized value of costs and
benefits of the final rule.
Table 2. Summary of Present Value Costs and Benefits of the Final Rule ($ 2019 million over 10
years)
Costs
Primary
Low
Primary
Low
(7%)
(7%)
High (7%) (3%)
(3%)
High (3%)
$0.60
$0.06
$1.13
$0.60
$0.06
$1.13
Cost Savings
Net Costs
not
not
not
not
not
not
quantified quantified quantified quantified quantified quantified
$0.60
$0.06
$1.13
$0.60
$0.06
$1.13
Table 3. Summary of Annualized Costs and Benefits of the Final Rule ($ 2019 million over 10
years)
15
Costs
Primary
Low
Primary
Low
(7%)
(7%)
High (7%) (3%)
(3%)
High (3%)
$0.09
$0.01
$0.17
$0.08
$0.01
$0.15
Cost Savings
Net Costs
not
not
not
not
not
not
quantified quantified quantified quantified quantified quantified
$0.09
$0.01
$0.17
$0.08
$0.01
$0.15
G. International Effects
The requirements of the final rule are the same, whether the De Novo requester is a
domestic firm or a foreign firm. We do not have enough information to estimate the number of
foreign firms that would submit De Novo requests.
H. Uncertainty and Sensitivity Analysis
We lack direct evidence about how the medical device industry will respond to a more
transparent and predictable De Novo classification process. However, a rational, self-interested
manufacturer of a medical device that is eligible for the De Novo classification pathway would
utilize the De Novo classification process more frequently if the De Novo classification process
has lower costs than an alternative process. We recognize that there is considerable uncertainty
about how much a more predictable De Novo classification process will lower costs or how
much more frequently manufacturers will use the De Novo classification process. Over time as
the industry gains experience with the revised requirements, we expect more better quality
submissions. In addition, we are uncertain about the amount of time we will save reviewing
higher quality requests.
16
I. Analysis of Regulatory Alternatives to the Rule
In this section, we consider extending the effective date of the final rule. The current
effective date is 90 days after the rule publishes. If we extend the effective date to one year, we
would delay some costs for industry to read the rule. This delay would reduce the costs of this
final rule.
III. Final Small Entity Analysis
The Regulatory Flexibility Act requires Agencies to analyze regulatory options that
would minimize any significant impact of a rule on small entities. This analysis, as well as other
sections in this document, serves as the Final Regulatory Flexibility Analysis, as required under
the Regulatory Flexibility Act.
We use the North American Industry Classification System (NAICS) codes used by the
International Trade Administration in their 2016 Medical Devices Report (Ref. 6) to represent
the medical device industry. 1 The U.S. Small Business Administration defines small businesses
in these industries as ranging between 750 and 1,250 employees. 2 We use detailed data by firm
size from the Statistics of U.S. Businesses in 2012 to estimate the proportion of firms that are
Industries include: NAICS 325413, In-Vitro Diagnostics Substances Manufacturing; NAICS 334510,
Electromedical and Electrotherapeutic Apparatus Manufacturing; NAICS 334517, Irradiation Apparatus
Manufacturing; NAICS 339112, Surgical and Medical Instrument Manufacturing; NAICS 339113, Surgical
Appliances and Supplies Manufacturing; NAICS 339114, Dental Equipment and Supplies Manufacturing; and
NAICS 339115, Ophthalmic Goods Manufacturing.
2
U.S. Small Business Administration, Table of Size Standards: https://www.sba.gov/document/support--table-sizestandards.
1
17
small and the revenue per firm. 3 For industries with a small business cutoff of 1,250 employees,
we estimate the number of firms by assuming half of the firms in the 1,000 to 1,499 employee
category would have under 1,250 employees. We estimate that between 89% and 99% of firms
in these NAICS codes are small. We estimate that the minimum revenue per firm is around
$325,000 for firms with 0 to 4 employees in the NAICS 339114 category.
This final rule will impose a small administrative burden of up to $300 per year on each
affected small entity. This cost is less than 0.1% of the smallest annual per-firm revenue in this
industry. Because small entities affected by this final rule will incur very small one-time costs to
read and understand the rule, we certify that the final rule will not have a significant economic
impact on a substantial number of small entities.
IV. References
The following references marked with an asterisk (*) are on display at the Dockets
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240-402-7500 and are available for viewing by interested persons
between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at
https://www.regulations.gov. References without asterisks are not on public display at
https://www.regulations.gov because they have copyright restriction. Some may be available at
the website address, if listed. References without asterisks are available for viewing only at the
The 2012 Statistics of U.S. Businesses has detailed information by entity size, including for entities with greater
than 500 employees. https://www.census.gov/programs-surveys/susb/data/datasets.2012.html
3
18
Dockets Management Staff. FDA has verified the website addresses, as of the date this
document publishes in the Federal Register, but websites are subject to change over time.
1. *83 FR 63127-63146. Medical Device De Novo Classification Process: Proposed
Rule. December 17, 2018.
https://www.federalregister.gov/documents/2018/12/07/2018-26378/medical-devicede-novo-classification-process
2. *Preliminary Regulatory Impact Analysis. Medical Device De Novo Classification
Process. https://www.fda.gov/media/122986/download
3. Ross, Jeffrey, and Ginsburg, Geoffrey. 2003. “The Integration of Molecular
Diagnostics with Therapeutics: Implications for Drug Development and Pathology
Practice.” American Journal of Clinical Pathology 119: 26-36.
4. *Guidelines for Regulatory Impact Analysis, HHS September 2014, Revised Draft
with May 2015 Update
5. *Bureau of Labor Statistics. National Occupational Employment and Wage
Estimates. Occupational Employment Statistics, General and Operations Manager
(North American Industry Classification, NAICS, code 339100) May 2019.
https://www.bls.gov/oes/current/naics4_339100.htm, accessed February 4, 2021.
6. *U.S. Department of Commerce, International Trade Administration, Industry &
Analysis. (May 2016). 2016 Top Markets Report Medical Devices: A Market
Assessment Tool for U.S. Exporters.
19
| File Type | application/pdf |
| File Title | Medical Device De Novo Classification Process; Final Rule |
| Subject | OCC CBD |
| Author | Food and Drug Administration |
| File Modified | 2021-10-04 |
| File Created | 2021-10-04 |