UDI

Requesting an Extension/Exception to the U.S. FDA UDI Rules

May 19, 2014 Dirk Rodgers

Are you behind in your preparations for the September 24, 2014 deadline for Unique Device Identification on class III medical devices (see “UDI Deadline For Class III Medical Devices Quickly Approaching”)? Do you need to apply for an 1-year extension of the compliance date for a class III medical device or a device licensed under the Public Health Service Act? Do you need to file an exception from or alternative to the requirement for the label of a device to bear a unique device identifier (§ 801.20) or other UDI requirement under 21 CFR 801 Subpart B (Labeling Requirements for Unique Device Identification) for a specified device or a specified type of device? Do you need to continue using an existing National Health Related Item Code (NHRIC) or National Drug Code (NDC) Labeler Code that was assigned to you by the FDA in the past (see “UDI And The Approaching End Of The NDC”)?

If you answered “yes”, or, “Uh…I think so”, to any of the questions above, then Continue reading Requesting an Extension/Exception to the U.S. FDA UDI Rules →

DSCSA, FDA

The 2014 FDA DSCSA Workshop

May 12, 2014 Dirk Rodgers

The U.S. FDA held their first industry workshop focusing on the new Federal Drug Supply Chain Security Act (DSCSA) last Thursday and Friday at FDA Headquarters in Silver Spring, MD. The goal of the workshop was to help the FDA collect ideas and preferences from industry stakeholders and technology providers for meeting the January 1, 2015 DSCSA requirement to exchange Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS). The FDA must publish a draft guidance document on the same topic before November 27, 2014, so this workshop, plus the responses to the recent docket, will help them write that draft.

The workshop was held in a large room with eleven big tables, each with about 18 chairs around them. The FDA had Continue reading The 2014 FDA DSCSA Workshop →

UDI, Uncategorized

UDI Deadline For Class III Medical Devices Quickly Approaching

May 5, 2014 Dirk Rodgers

There is a lot of angst in the pharma community right now about the fast approaching DSCSA first deadline for the exchange of transaction data, but the medical device community is dealing with an even earlier deadline: the September 24, 2014 deadline for UDI on class III medical devices.

The FDA UDI web page lists the following requirements for the September deadline, now less than five months away:

The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
Data for these devices must be submitted to the Global Unique Device Identifier Database (GUDID). § 830.300.
A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014.
Class III stand-alone software must provide its UDI as required by § 801.50(b).

Continue reading UDI Deadline For Class III Medical Devices Quickly Approaching →

DSCSA, HDMA

Just Released – The HDMA EDI ASN Guidance For DSCSA

April 30, 2014 Dirk Rodgers 3 Comments

NOTICE: The HDMA has updated this guideline again only a few months after this essay was published. Please see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again” for additional information. — Dirk.

The Healthcare Distribution Management Association (HDMA) has just published their much anticipated new guidance on applying the Electronic Data Interchange (EDI) 856 Advance Ship Notice (ASN) transaction set toward compliance with the new U.S. Drug Supply Chain Security Act (DSCSA), which is Title II of the Drug Quality and Security Act (DQSA). HDMA members and non-members can download a copy of the new document here. Make sure you look for “HDMA Electronic Data Interchange (EDI) Guidelines for the 856 Advance Ship Notice to Support Implementation of DSCSA“. (See the image to the right.)

The new guidance is voluntary, like all HDMA guidance (see “GS1 Identifiers and EPC’s in EDI Messages: Important New HDMA Guidance” and “Updated HDMA Bar Code Guidance: A Must Read“), but companies who Continue reading Just Released – The HDMA EDI ASN Guidance For DSCSA →

Randomization

Randomization—An Interview with Ken Traub—Part 5: Other Approaches

April 30, 2014 Ken Traub

This is the last of a five part interview with Ken Traub, GS1 standards expert and independent consultant, on GS1 serial number randomization. The full series includes essays covering:

GS1 Serial Number Considerations
Properties of Randomization
Threat Analysis
Algorithmic Approach
Other Approaches to Randomization (this essay)

This week Ken talks about other approaches to serial number randomization. – Dirk. Continue reading Randomization—An Interview with Ken Traub—Part 5: Other Approaches →

Randomization

Randomization—An Interview with Ken Traub—Part 4: The Algorithmic Approach

April 28, 2014 Ken Traub 3 Comments

This is the fourth installment of a five part interview with Ken Traub, GS1 standards expert and independent consultant, on GS1 serial number randomization. The full series includes essays covering:

In this installment, Ken explains the algorithmic approach to serial number randomization. – Dirk. Continue reading Randomization—An Interview with Ken Traub—Part 4: The Algorithmic Approach →

Randomization

Randomization—An Interview with Ken Traub—Part 3: Threat Analysis

April 25, 2014 Ken Traub

This is the third of a five part interview with Ken Traub, GS1 standards expert and independent consultant, on GS1 serial number randomization. The full series includes essays covering:

This week Ken introduces the concept of threat analysis. – Dirk. Continue reading Randomization—An Interview with Ken Traub—Part 3: Threat Analysis →

Randomization

Randomization—An Interview with Ken Traub—Part 2: Properties of Randomization

April 23, 2014 Ken Traub 3 Comments

This is the second of a five part interview with Ken Traub, GS1 standards expert and independent consultant, on GS1 serial number randomization. The full series includes essays covering:

GS1 Serial Number Considerations
Properties of Randomization (this essay)
Threat Analysis
Algorithmic Approach
Other Approaches to Randomization

This week Ken introduces three properties of randomization. — Dirk.

Continue reading Randomization—An Interview with Ken Traub—Part 2: Properties of Randomization →

RxTrace

Requesting an Extension/Exception to the U.S. FDA UDI Rules

The 2014 FDA DSCSA Workshop

UDI Deadline For Class III Medical Devices Quickly Approaching

Just Released – The HDMA EDI ASN Guidance For DSCSA

Randomization—An Interview with Ken Traub—Part 5: Other Approaches

Randomization—An Interview with Ken Traub—Part 4: The Algorithmic Approach

Randomization—An Interview with Ken Traub—Part 3: Threat Analysis

Randomization—An Interview with Ken Traub—Part 2: Properties of Randomization

…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance