FDA has proposed the Unique Device Identification (UDI) rule in July 2012. The UDI requirement will be subsequently applied to all three types of medical devices. Type III Devices with the highest risk of safety will be required to adhere to the UDI rule for its basic label and packaging design within the first year of publication of UDI rule. Type II and Type I devices will be required to do so within five and seven years respectively.



Read more in FDA's official online publication.

FDA Warning letter trending FY2012

The following is a FY2012 YTD report of warning letters issued by FDA. CDRH continues to be the  clear lead as the office with most letters issued at 85 letters. This is roughly equivalent to FY2011's number at the same period. Total warning letters cited numbered at 610. cGMP/QSR/Medical Device is the second most often cited violation.

Definition of medical device is generally applicable to a wide number of products. Manufacturers and component suppliers may not be sufficiently aware of QSR requirements, or in many cases, may not  have sufficient resources to be fully compliant with QSR requirements. 

Subjects of Warning letter by count: CGMP/QSR/Medical Devices/Adulterated 58 Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 44 Illegal Drug Residue 40 Seafood HACCP/CGMP for Foods/Adulterated 28 CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 23 CGMP for Finished Pharmaceuticals/Adulterated 21 CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 20 Seafood HACCP/Adulterated 20 New Drug/Misbranded 19 Animals for Sale for Slaughter as Food/Adulterated 17 Modified Risk Tobacco Products 15 Medical Device Reporting/Misbranded 14 CGMP/QSR/Medical Devices/Adulterated/Misbranded 14 Clinical Investigator 14 Premarket Approval/Misbranded/Adulterated 13 CGMP for Foods/Seafood HACCP/Adulterated 11 CGMP Regulation For Food/Adulterated 10

A recent RAPS (Regulatory Affairs Professional Society) article examined the recent establishment of International Medical Device Regulator Forum (IMDRF), a successor of Global Harmonization Task Force (GHTF) with a focus on international regulatory compliance.

There are a lot of interesting areas of work IMDRF is currently working on, for example Unique Device Identification (UDI) , National Competent Authority Report (NCAR) postmarket performance monitoring for globally-sold devices.

Read more on the published article on Regulatory Focus. 

Regulators, Industry Discuss Potential Impact of IMDRF

http://www.imdrf.org/index.asp

A few things to remember to establish and maintain an effective metrology, calibration program for your medical device manufacturing facility

1.Develop a clear and retrievable document system: This includes calibration procedures certificate, labels and archiving methods!

2.Properly conduct calibration incidences and out-of-tolerance events. Document clearly and archive!

3. Selecting an external metrologist and calibration provider? Understand ISO/IEC17025:2005 and NIST traceability concepts. 

4. Invest in an equipment calibration retrieval system. A system that automatically populates a list of equipment due for periodic checks on-demand.

Making a case for quality has always been one of biggest challenge for any quality professional, even before he/she can start a company-wide quality improvement project. Are there ways to gain traction?



1. Consider/Look for regulatory compliance arguments: Compliance to national, local statutory laws are mandatory for businesses, especially in regulated businesses like pharmaceuticals and medical devices. Avoiding warning letters, recalls and consent decrees make compelling reasons for quality improvement.

2. Understand and promote Cost of Quality: The cost of preventing and mitigating poor quality is estimated at 33% of the cost of addressing problems that brought along by poor quality. With the rising figures of legal compensation payments, cost to rework and scrap, COQ also makes good argument.

3. Divide and Conquer : fostering a quality-oriented business ethics takes lots of solicitation and negotiation. Its not always easy to hit up the management at the very early stage; start with a department that is receptive and in need of improvement. Achieve small wins and promote the success by words-of-mouth.

Thinking about  building an effective team in office? Think military!

1. Visualize an "ideal" team with a tactical objective, as well as strategic departmental goals. 
2. Establish individual responsibility and corresponding baseline competency based on the tactical objective. Rigorous development plan. Team member understand his/her role and importance in the team.
3. Embed team-building activity into daily work routines, but not only for special occasions : "free" team lunches to favorite restaurants, coffee breaks, engage in occasional pranks and jokes.
4. Expose the team to contingencies and crises. Foster individual leadership.  Enhance team adaptability to unusual work environments.
5. Win small "battles". Celebrate individual and team achievements to build sense of belonging and Elitism.

For those of you operating in Brazilian Medical device market, do not overlook the device vigilance requirements in Resolution - RDC No. 67 of 21 December 2009 .


The following matrix summarizes the critical reporting scenario and associated regulatory time constraints.

So you have been practicing 100meter sprint for some time now, in preparation for the big time. But how do you fare against other competitors? You won't unless you put someone next to you on the starting line.


Have you implemented Key Performance Indicators (KPIs)  for your organization? KPI can be considered as a big chunk of the Six Sigma Measure phase, as well as forming the boundary conditions for the Control phase.


Realistic, purposeful KPIs will tell you the following critical health parameters of your business

1. Efficiency
2. Quality
3. Customer Satisfaction

Data collected for KPI will also enable management to benchmark own performance against competitors and industry standard. 


So think competitive; set goals against others and measure KPI honestly.

To Quality or not , that is the question? 
Implementation of a Quality system is often looked upon by smaller businesses as cumbersome, ceremonial process that is non-value adding. Is this really the case?

Consider the following benefits that a well managed Quality program can bring to your business:

1. Lower operating cost, improving margin by reducing production waste (Lean, cost of quality)
2. Certification to ISO standard, or compliance with ISO standard to meet customer expectations
3. Competitiveness, innovation and value of the product
4. Effective Quality Management System that is required and complies with regulatory environment 

Summary of recent warning letters and some fairly amusing inspectional findings.

Warning Letter Analysis: FDA Warning Letters Cite Companies for Marketing, cGMP, Design Deficiencies RAPS News - Article View

It is absolutely essential to establish a robust and effective complaint handling systems for device-related reportable events in compliance with 21 CFR 803. However, the trending of such reportable device complaints is also explicitly required under 21 CFR 820.100, and often overlooked by Regulatory compliance professionals.


Sec. 820.100 Corrective and preventive action

(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:

(1) Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;

Establishing a statistical method to analyze/trend device complaints and other key Quality indicator will be instrumental in maintaining Quality Management of the product, as well as compliance with regulatory requirements.