Monday, September 25, 2017

Notes on Clinical Studies

510(K) Studies

Each person who wants to market in the US a device intended for human use must
submit a 510(k) to the FDA

It is a premarket submission to demonstrate the device is at least as safe

and eective as a marketed device not subject to Premarket Approval

Devices are classified by risk (class 1-3) where class 1 are devices of minimal risk
(and dont require clinical trials) and class 3 is substantial risk and does require
clinical trials

IND

Investigational New Drug

Types

Investigator IND

Submitted by physician who initiates and conducts an investigation

under whose direction the drug is administered

Used to propose studying unapproved or approved product

for new use

Emergency Use IND

Allows the FDA to authorize use of an experimental drug in an

emergency situation that doesnt allow time for submission of an IND
in accordance with typical protocol

Also used for patients who dont meed criteria of existing

protocol

Treatment IND

Submitted for experimental drugs showing promise in clinical testing

for serious or immediately life-threatening conditions while final
clinical work is conducted and FDA review takes place

Categories

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 Monday, September 25, 2017
Commercial IND vs Research IND

Information INDs contain

Preclinical data to see whether it is reasonably safe for initial testing (Animal)

Manufacturing info pertaining to composition, manufacturer, stability, and

controls used

Clinical protocols and Investigator information to assess whether the initial

phase trials are too risky or not

PMAs

Premarket approval is the FDA process of scientific and regulatory review to

evaluate the safety and eectiveness of Class III medical devices

required to obtain marketing clearance

Most stringent of type of device marketing application required

Approval based on determination that the PMA contains sucient scientific

evidence to assure device is safe and eective for intended use

Typically includes a technical section, non-clinical labs studies section, and clinical
investigations section

HDEs

Humanitarian Device Exemption: Marketing application for a humanitarian use

device of the FDA

HUD that either occurs in pediatric patient or small number of adult patients (but
not both)

Used to gather clinical evidence on orphan treatments that cant collect move much
bc its an orphan drug