Device Regulatory

MDSAP Countries
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Today's Topic:
US FDA - Types of Device
Submissions and
Programs to help
submission prep

2022/1/31 Vol11
 Types of FDA Device Submission &
Programs that help preparation
Types of Submission
510(k) Premarket Notification
Traditional, Special, Abbreviated
PMA Premarket Approval
IDE (Investigation Device Exemption)
De Novo Classification Request
HDE (Humanitarian Device Exemption)
RFD (Request for Designation)
Pre-RFD

FDA Programs to help prepare a submission

CDRH Breakthrough Devices Program
Safer Technology Program (STeP)
Q-Sub Program
 Types of Submission
510(k) Premarket Notification
Class II devices. Demonstrate substantial
equivalence to a legally marketed Class II predicate
device.

PMA Premarket Approval

Class III devices. Demonstrate reasonable
assurance of safety and effectiveness. Clinical data
is typically necessary.

IDE (Investigation Device Exemption)

IDE approval is necessary prior to iniciating a
clinical study that will be used for a PMA or 510(k)
submission.
Clinical Study protocol etc are necessary.
IDE devices are exempt from QSR except for
design control.
 Types of Submission
De Novo Classification Request: 513(f)(2)
Request classification for novel devices when
general/Special controls are considered
appropriate (= it is not as high in risk that requires
PMA) but there is no predicate.
The request can be made before submitting a
510(k) or after receiving NSE to the predicate that
you selected in your 510(k) submission.

HDE (Humanitarian Device Exemption)

HUD (humanitarian use device) is a device
intended to benefit patients in the treatment or
diagnosis that affects or is manifested in not more
than 8,000 individuals in the US per year.
If DHE is granted, the PMA effectiveness
requirements (= clinical study data demonstrating
effectiveness for the intended populations) is
exempt, and financial incentive for development
applies.
 Types of Submission
RFD (Request for Designation) & Pre-RFD
Request a formal agency determination of a
combination product’s primary mode of action
(POMA) as well as assignment of the lead agency
center for the product’s premarket review and
regulation (CDRH, CDER or CBER).
Pre-RFD is an informal discussion with the FDA to
prepare for the formal RFD.
FDA Program to help prepare a submission
CDRH Breakthrough Devices Program
Expedited development, assessment and review.
Eligibility: The device represent breakthrough
technology and provides more effective treatment
or diagnosis of life-threatening or irreversibly
debilitating human disease or conditions. And
there is no approved/cleared device.
Applicable for 510(k), PMA submissions or De novo
request.
Safer Technology Program (STeP)
Expedited development, assessment and review.
Devices and device-led combination products that
are reasonably expected to significantly improve
the safety of currently available treatments or
diagnostics that target an underlying disease or
condition associated with morbidities and
mortalities less serious (not life-threatening level)
than those eligible for the Breakthrough Devices
Program.
FDA Program to help prepare a submission
Safer Technology Program (STeP) cont.
Devices and device-led combination products that
are reasonably expected to significantly improve
the safety of currently available treatments or
diagnostics that target an underlying disease or
condition associated with morbidities and
mortalities less serious (not life-threatening level)
than those eligible for the Breakthrough Devices
Program.
Applicable for 510(k), PMA submissions or De novo
requests.

Q-Sub Program
Various FDA discussion methods to help prepare a
submission or response to AI.
Pre-Sub; SIR (submission issue request);
discussions prior to the Breakthrough or STeP
designation request.
Device Regulatory
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