Template / format for Device History File & Design Verification of transdermal patch

[v9991]

Transdermal patches
Transdermal patches are considered as devices (by US FDA)

(b) Device with primary purpose of delivering or aiding in the delivery of a drug and distributed containing a drug (i.e., "pre*filled delivery system")
EXAMPLES

• nebulizer
• oxygen tank for therapy and OTC emergency use
• pre*filled syringe
• transdermal patch

Status: Combination Product

I am looking for templates/formats used in typical regulated environment, and for combination products, devices or drug+device combinations.

any references would be of great help.

 

[yodon]

Re: Template / format for Device History File & Design Verification of transdermal p

The items you mention (DHR and design verification) are very much going to be unique for each product. Design Verification is the means by which you demonstrate the item meets the requirements you've established.

The DHR contents is spelled out nicely in the regulation (http://www.ecfr.gov/cgi-bin/text-id...true&node=pt21.8.820&rgn=div5#se21.8.820_1184). It must contain:
(a) The dates of manufacture;
(b) The quantity manufactured;
(c) The quantity released for distribution;
(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;
(e) The primary identification label and labeling used for each production unit; and
(f) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used.

So in addition to being specific to your product, it's also going to be driven by your manufacturing processes.