U.S. Food and Drug Administration
Center for Devices and Radiological Health Document Control Center
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
FDA Pre-Submission Cover Letter
QSub Type: PreSubmission
Modern Medical Equipments will share current product development plans. We look
forward to feedback from the FDA.
Device name: Osteoporosis Micro-needle Patch
Company Partners: Ammar Sheikh, Abdulrahman Sindi, Deanna-Nicole Busog , Ansam
Alkhafaji.
Mailing address:
Catholic University of America
620 Michigan Ave NE,
Washington, DC 20064
Table of Contents
I.
II.
Device Description
Proposed Intended Use
III.
New Modification
IV.
Product Classification
V.
VI.
VII.
VIII.
IX.
Submission Type
Product Code
CFR Regulation Number
Overview of Product Development
Specific Questions
X.
Feedback
XI.
References
I. Description
Technological advancements have seen the formulation of concepts that are much smaller
in size and efficient as compared to the older conventional ways. Microneedle patches comprise
of microneedles less than a millimeter long and are intended to deliver drug substances and
vaccinations into the skin (Arya et al.). In the event of administering the patch, the
microneedles dissolve in the skin within a short time, preferably twenty minutes or so. This
process helps to see that the drug is delivered into the body. Typically, the patches may contain
coated microneedles or dissolving microneedle patches containing solid metal.
Microneedle patches are aimed at replacing or instead substituting the conventional
needle-and-syringe injections.
II. Proposed Intended Use:
Meant as an alternative to the use of needles to administer drugs through the skin,
through the dissolution of the coating on the microneedle patches, or the dissolution of
water-soluble microneedles. The target population for this device are patients living with
osteoporosis. Our microneedle patches can treat osteoporosis through the delivery of the
parathyroid hormone.The microneedle patches can be placed on different parts of the body
including arms, abdomen, and thighs. This device is meant to be used by caregivers, including
doctors, nurses, and clinic staff, and can also be self-administered by the patient. Each patch is
intended for single use drug administration. Our device is intended for prescription use. Each of
our patches will have a set amount of the parathyroid hormone, which we will still have to
determine, but the dosage, prescription, and number of patches for daily patient use will be
determined by the caregiver.
III. New modification
The micro-needle patch is a new device. It cannot be easily used by patients themselves
and are therefore utilized primarily in the clinic or at home by patients who have received special
training on correct injection method. Rather than avoiding needles, it is proposed shrinking the
needle to micron dimensions in order to make use of its powerful delivery capabilities while
improving patient compliance and safety. As a micron-scale device, a microneedle should be
large enough to deliver almost any drug or small particulate formulation, but still be small
enough to avoid pain, fear and the need for expert training to administer.
Microneedles can generally be classified into four types according to drug delivery
methods: solid, coated, dissolving, and hollow microneedles. Each type of microneedle has pros
and cons. A solid microneedle punctures the surface of the skin and applies the drug to the skin
layer, allowing the drug to slowly diffuse through the holes. It has the advantage of preventing
pathogenic infection but the drug delivery effect is low. Coated microneedle is typically coated
with a water-soluble drug. The microneedle is attached to the skin, the drug is quickly delivered
to the skin, and then the microneedle is removed. It has an advantage of delivering a very small
fixed amount of drug. Unlike other types of microneedle, the dissolving microneedles are made
of water-soluble materials. When the microneedle is pushed into the skin, the microneedle melts
in the skin, releasing the drug in the microneedle (Ki Mun).
IV. Product Classification:
● Class: II
V. Submission Type:
● 510(k) #K874024
VI. Product Code:
● FMI
VII. CFR Regular number:
● 880.5570: Hypodermic Needle
VIII. Overview of Product Development
The studies performed were done on human subjects to test tolerability, usability and
self-administration capabilities of our microneedle patches, and were not yet filled with any
drugs. Our studies were performed on 15 participants, eligibility to enter the studies included an
age range from 18-57 years. Participants were also required to have normal skin with no allergies
to materials used in our patches, or had been previously exposed to any microneedle patches.
The patches we used in this study were made out of biocompatible and water-soluble materials;
polyvinyl alcohol and sucrose.
Since we are also testing to make sure our patches can be self-administered, the patches
had a grade tape that made a clicking sound, acting as force-feedback, when a sufficient force
was applied. Unlike previous studies performed, high-velocity insertion devices were not used
here, devices which are typically used to ensure that the needles are penetrated adequately into
the skin. Instead, pressure from the thumbs of administers are being used. The patches were
stored for approximately four weeks, and observations under a microscope were done to ensure
their viability before carrying out of the research.
For the 15 eligible participants, the experiment first involved a briefing on the
procedures. A short instructional presentation was first made on self-administration. Later, each
participant received three patches; one which was to be self-administered, and two which were to
be investigator-administered. Each arm where a patch was placed received markings, made by
staining the site on the skin, to help in usability measurement. A survey was later
conducted to gauge the tolerability of the patches by the participants. Days later, visits to the
study site were made for tolerability measurements, which involved checking for pain,
tenderness and size and grade of swelling (erythema) on the skin.
Once the experiments were completed, assessments of the results were made. Skin
tolerability studies were established to recognize and categorize reactions in the skin.
Tolerability of the skin is dependent on the process of administration of the patch and the
excipients left in the skin once the dissolution of the microneedles takes place. Interestingly, only
one out of the fifteen participants reported tenderness at the skin site on the material day, but the
pain was no more on the second day (Arya et al. 3). Apart from this finding, none of the subjects
indicated swelling of the skin site; the patches were tolerated appropriately with only relative
transient erythema that was no more by the seventh day (Arya et al. 3).
The usability of the microneedle patches was determined, by checking the reliability in
the manner in which it dissolved in the skin. Self-administration after very brief training on the
same was also identified, and it was noted that the usability was identical between investigator
and self-administration and the patches were adequately dissolved into the skin. We also found
that the average wear time would be about 20 minutes, which is the time it took for the patches to
dissolve into the skin. Acceptability reports indicated that majority preferred microneedle patch
administration over the conventional way of needle injections.
Further Development:
In order to facilitate the delivery of the entire intended drugs dose into the skin, some
modified fabrications need to development . These include micro molding of arrowhead dMNs
mounted on mechanically strong shafts or dMNs presenting an elongated base increasing the
needle length . There is some modification which include patch pillars to improve the delivery
efficiency. After patch application into the skin, dMNs separate from the pillars due to a tensile
breaking force of the fibrous sheet between the pillar and the dMN. This allows a proper
implantation of the dMNs into the skin and removal of the remaining back plate without the need
to wait dMN dissolution (R. Prausnitz).
IX. Questions
● The study was conducted on a group of 15 participants in the age of 18-57 years old.
What would be a better age range that can participate in the same study to provide an
adequate feedback?
● Other than the conventional needle-and-syringe injections, what would be the best
medical device to compare our product with, in terms of safety and effectiveness?
● Does the FDA have any feedback regarding the studies we have conducted to further
develop the safety and effectiveness of our product?
X. Feedback
● Preferred methods to receive feedback:
- E-mail: asheikh1417@gmail.com
- Phone : +1(202)999-5523
- Mailing address:
Catholic University of America
620 Michigan Ave NE,
Washington, DC 20064
● Meeting request dates and times:
- October 24th 2018, at 2:30pm
- November 1st 2018, at 9:00am
- November 10th 2018, at 11:00am
XI. References
● FDA.(2017).Guidance for industry and food and drug administration staff. Retrived from
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidanced
ocuments/ucm575923.pdf
● FDA. 510(k) access data. R
etrived from
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=2529
● Arya, Jaya, and Mark R. Prausnitz. “Microneedles for Drug and Vaccine Delivery.”
Journal of Controlled Release : Official Journal of the Controlled Release Society, U.S.
National Library of Medicine, 28 Oct. 2016,
www.ncbi.nlm.nih.gov/pmc/articles/PMC4871790/.
● Kwon, Ki Mun, et al. “Microneedles: Quick and Easy Delivery Methods of Vaccines.”
Clinical and Experimental Vaccine Research, The Korean Vaccine Society, July 2017,
www.ncbi.nlm.nih.gov/pmc/articles/PMC5540964/.
● Arya, Jaya, et al. “Tolerability, Usability and Acceptability of Dissolving Microneedle
Patch Administration in Human Subjects.” Biomaterials, vol. 128, 2017, pp. 1–7.,
doi:10.1016/j.biomaterials.2017.02.040.
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