The 21st century cures act a focus on title iii subtitle f – medical device innovations

1. The 21st
Century Cures Act a focus on Title III Subtitle F – Medical Device Innovations
David Loeser
Northeastern University – RGA 6202 Winter 2017
March 12, 2017

2. In 2016 President Barak Obama passed his second largest piece of legislation, The 21st
Century Cures Act. Designed for patient first, it will improve, redirect and innovate the overall
delivery of patient care for the next ten years.
Issue
Currently the FDA is tangled with various ways of managing medical devices. The FDA
is responsible for device designation, approval, enforcement, and many other important tasks.
The result is a clogged pipeline, accumulation of massive fees and an in efficient way to get
medical devices into patient’s hands.
Rule
The 21st
Century Cures Act -Title III Development – Subtitle F Medical Device
Innovations consists of ten subsections rewriting, improving and adding new rules to innovate
and expedite medical device development as well as clarifying device software.
§ 3051. Breakthrough devices
§ 3052. Humanitarian device exemption
§ 3053. Recognition of standards
§ 3054. Certain class I and class II devices
§ 3055. Classification panels
§ 3056. Institutional review board flexibility
§ 3057. CLIA waiver improvements
§ 3058. Least burdensome device review
§ 3059. Cleaning instructions and validation data requirements
§ 3060. Clarifying medical device software regulation. (U.S. House of Representatives,
2017) For the purpose of this paper we will focus on five subsections.

3. Analysis
§ 3051. Breakthrough devices
“The purpose of this section is to encourage the Secretary, and provide the
Secretary with sufficient authority, to apply efficient and flexible
approaches to expedite the development of, and prioritize the Food and
Drug Administration’s review of, devices that represent breakthrough
technologies.” (U.S. House of Representatives, 2017) Breakthrough
medical devices are defined as advanced technological products that are
not currently approved or cleared, and offer major advantages when
compared to current available devices. For a device to receive
“breakthrough” designation it must “reduce or eliminate the need for
hospitalization, improve patient quality of life, facilitate patients’ ability to
manage their own care, or establish long-term clinical efficiencies.” (U.S.
House of Representatives, 2017)
No later than 60 days after requesting breakthrough designation the secretary will decide
if the device meets the criteria, rewarding it with expedited development and priority review.
Under priority review a staff member will be assigned ensure all proper clinical testing,
communication with the FDA, advisory committee input and all traditional resources are aligned.
Currently the FDA has a voluntary expedited access pathway (EAP) program that is
similarly designed to reduce time and cost, bringing medical devices to patients quicker. § 3051
section 515C will be added to EAP, allowing 510(K) devices to now be eligible for EAP (FDA,
2017) § 3051 will unclog the pipeline of innovative products waiting for approval. Without §
3051. Patients would not be prescribed life changing devices by their doctor simply because the

4. doctors are unaware that the device exists. This subsection is a major advantage of precision
medicine and the development of preventative healthcare since one of the provisions is that the
device must “reduce or eliminate the need for hospitalization.” (U.S. House of Representatives,
2017)
§ 3053. Recognition of standards
This subsection is for the purpose of training all FDA employees that are reviewing
PMAs, they will receive periodic training so they have a standard recognition of what is required
currently for a PMA submission and standards required to an employee’s specific area of device
review. Previous guidance and standard operating procedures will be identified and updated, to
bring everything to current date. Included with the process of these updates, will be the
identification of foreign regulatory authorities and whether recognition of standard will promote
harmonization among regulatory authorities in the regulation of devices. (U.S. House of
Representatives, 2017)
§ 3053 should complement §3051 minimalizing mistakes made during the PMA
submission. Critics who believe the § 3051 will allow devices to become approved too quickly
need to understand the areas like § 3053 are being implemented to ensure that FDA staff
reviewing PMAs will have periodic updated to any PMA requirements therefore they will always
be current with the standards needed to approve a device. § 3053 is also device specific, so the
FDA associate approving product A will have periodic training in that device specific area, this
will allow for a more efficient review process.
§ 3054 Certain Class I and Class II Devices
The FDA is current backlogged with PMA applications, § 3054 is designed to move
certain Class II devices down to Class I, Class I devices to 510(K) exempt. This should free up

5. resources that are needed to review and approve devices. As mentioned in § 3053 FDA personal
who review PMAs are reviewing device specific applications.
This is a risky subsection because a device can always be moved back, and for that to
happen an adverse event must be recorded. However, there are many devices that no longer need
to be Class I because their technology has maxed out and there is no longer any possibility to
improve it or change it, they will be given the designation of 510K exempt.
Although § 3054 does not mention PMA Class III medical devices, companies will make
requests to have their devices moved to Class II. This is a great example of who should be
making these decisions, our government or the FDA.
§ 3059 Cleaning Instructions and Validation Data Requirement
There will be a published list of all identified reusable devices that fall under subsection
(k). Those devices will be required to have instructions for use, and have validated data of
cleaning, disinfection, and sterilization instructions.
This simple section is of great value. In 2015 three patients had procedures performed
using dirty endoscopes, all three were diagnosed with carbapenem resistant bacteria (CRE), and
two were fatal. At UCLA Medical Center that same year they estimate that over 170 patients
were exposed to dirt endoscopes. (Rosenfeld, 2016)
§ 3059 will reinforce the importance of formal documented and validated cleaning
instructions, with the expectation that users of medical devices will make these instructions part
of their best practices. Tamper proof tags will be utilized to help healthcare staff in identifying a
clean or dirty device.
§ 3060 Clarifying Medical Software Regulation
With the recent implementation of Electronic Health Record Systems (EHR) and growing

6. market of health wearables it was time for some clarification. This is an important § it outlines
five major categories that the FDA will not monitor as medical devices. Administrative and
operational (appointment software), wellness applications for tracking exercise, EHRs, software
for transferring (storing, converting formats or displaying data and results) and clinical decision
software. (Slabokin, 2017)
The clarity and understanding is important for physicians and medical device companies
in understand that the software they are using to develop and load onto devices might not be
monitored by the FDA. This reduces costs, allows for innovation and the opportunity to hire real
talent. Most important, it will enable patients to self-monitor using devices that otherwise would
have to be prescribed.
Conclusion
The 21st
Century Cures Act is an a much needed bill, title III will bring housekeeping to
an area of healthcare that is moving quickly. § 3051 loosens the ability for one to get a device
approved, a much needed shove to get the pipeline clean and put devices in patient’s hands.
Companies that utilize these new rules could have a development cycle that is faster.
An example would be, § 3051 allows the device to get approved quicker, no adverse
events recorded, company then petitions using § 3054 to have the device moved down from
Class II to Class I or 510K exempt, product is moved to 510K exempt, § 3060 will allow
developers to improve the devices software. This perfect example would allow for a previous
Class II device that was proven to be safe and efficient to be available to patients over the
counter, putting an awesome self-monitoring device in their possession.
Critics of the 21st
Century Cures Act believe that certain § 3051 will result in devices
coming to market too fast and not being safe and efficient. They need to understand that it’s a

7. necessary ruling because technology and innovation will run them down if they can’t keep up.
Other areas of criticism are § 3054 because some believe that if a product is designated as Class
II it should remain, this does not allow for innovation.
All five subsections discussed are favorable for getting devices into patient’s hands that
are safe and efficient. As well as ensuring that devices being utilized in a hospital environment
will be clean reducing the probability of a nosocomial disease or infection. Patients are entitled
to be worked on with identified reusable devices that will not harm them.
Final thought, the distribution of funding, specifically to the FDA who was only awarded
$500 Million, the total ten-year budget is $6 Billion. It speaks volumes that certain device
regulations should be made by a panel of medical doctors and not the government.

8. Works Cited
FDA. (2017, March 10). Expedited Access Pathway Program. Retrieved from FDA:
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYou
rDevice/ucm441467.htm
Rosenfeld, J. (2016, January 22). Unsanitary Medical Instruments Remain a Problem for
Patients. Retrieved from Rosenfeld Injury Lawyers:
https://www.rosenfeldinjurylawyers.com/news/unsanitary-medical-instruments/
Slabokin, G. (2017, March 19). 21st Century Cures Act clarifies FDA regulation of software.
Retrieved from Health Data Managment:
https://www.healthdatamanagement.com/news/21st-century-cures-act-clarifies-fda-
regulation-of-software
U.S. House of Representatives. (2017, March 9). 21st Century Cures Act. Retrieved from U.S.
House of Representatives Document Repoitory:
http://docs.house.gov/billsthisweek/20161128/CPRT-114-HPRT-RU00-SAHR34.pdf