Quality Progress - October 2013 - (Page 48)

StandardS OutlOOk by Les schnoLL regulatory nightmares Is a retrospective activity worth the cost and aggravation? “Do it right the first time” is a mantra This lapse of judgment has significant often used by quality professionals. In the implications, all of which could result in the applicable medical device directive associated world of regulatory affairs and the affected products being considered also can result in significant penalties. compliance, this adage also represents an misbranded and adulterated—and poten- appropriate mindset. tially recalled. Throughout my career, first as an Consider this not-so-hypothetical pean Union (EU), failure to comply with During my career, I have seen this situation numerous times. Theoretically, the U.S. Food and Drug Administration (FDA) employee and currently as an independent scenario: A manufacturer of a class II would be well within its authority to consultant, I have seen far too many times medical device, which requires a 510(k) require that the organization recall all of when this slogan was not taken seriously. premarket notification submission,1 has the products it ever manufactured. Many While I could provide countless examples distributed its product into U.S. inter- times, however, the agency exercises on the quality side, for purposes of this state commerce and into other countries, enforcement discretion and allows the article I’ll concentrate on the impact of including Canada, Europe and Australia. products to remain on the market if the retrospective regulatory activities required There is not a quality system in place—the organization complies with all regulatory because organizations and their manage- organization did not know that it needed requirements within a reasonable period ment did not do it right from the beginning. one. In addition, the organization has not of time. The number of potential regulatory trained its employees, and it does not have After the organization meets its obliga- disasters is quite large, but I have my own a registration and listing, device master tions, virtually everything must be created list of the top five nightmares that illus- record (DMR), design history file (DHF) or retrospectively. If you have ever been in a trate my point. Of course, organizations’ 510(k) submission. situation like this, you know that correc- specific names have been eliminated to Without these items, the product is tive action is not easy. While it is relatively adulterated and misbranded. In Canada, simple and straightforward to develop without complying with the registration the quality system, and to register and products were considered drugs or and quality system requirements, Health list the facility and manufactured medical devices.” Canada can mandate a recall. In the Euro- devices, it is not a pleasant task to retro- protect the guilty. Nightmare No. 1: “I didn’t know my spectively create a DMF, DHF or technical file for the EU. Developing and submitting a 510(k) takes significant time and can be expensive. The delays required to restart sales could range from several months to more than one year. During this period, the organization faces a negative cash flow—nothing is coming in, but expenses to implement the corrective actions are ongoing. My advice to the small entrepreneur who wants to enter the regulated arena: Be sure you know what you’re getting into, research the regulatory status of your products and if you’re not positive about the status, hire someone who can help you before you get yourself into serious trouble. 48 QP • www.qualityprogress.com http://www.qualityprogress.com

Table of Contents for the Digital Edition of Quality Progress - October 2013

Up Front
LogOn
Expert Answers
Perspectives
Keeping Current
Mr. Pareto Head
5S Shakeup
For the Greater Good
Turned On
Get There Faster
Career Corner
Standards Outlook
Quality in the First Person
QP Toolbox
QP Reviews
Back to Basics

Quality Progress - October 2013

https://www.nxtbook.com/naylor/ASQM/ASQM0719
https://www.nxtbook.com/naylor/ASQM/ASQM0619
https://www.nxtbook.com/naylor/ASQM/ASQM0519
https://www.nxtbook.com/naylor/ASQM/ASQM0419
https://www.nxtbook.com/naylor/ASQM/ASQM0319
https://www.nxtbook.com/naylor/ASQM/ASQM0219
https://www.nxtbook.com/naylor/ASQM/ASQM0119
https://www.nxtbook.com/naylor/ASQM/ASQM1218
https://www.nxtbook.com/naylor/ASQM/ASQM1118
https://www.nxtbook.com/naylor/ASQM/ASQM1018
https://www.nxtbook.com/naylor/ASQM/ASQM0918
https://www.nxtbook.com/naylor/ASQM/ASQM0818
https://www.nxtbook.com/naylor/ASQM/ASQM0718
https://www.nxtbook.com/naylor/ASQM/ASQM0618
https://www.nxtbook.com/naylor/ASQM/ASQM0518
https://www.nxtbook.com/naylor/ASQM/ASQM0418
https://www.nxtbook.com/naylor/ASQM/ASQM0318
https://www.nxtbook.com/naylor/ASQM/ASQM0218
https://www.nxtbook.com/naylor/ASQM/ASQM0118
https://www.nxtbook.com/naylor/ASQM/ASQM1217
https://www.nxtbook.com/naylor/ASQM/ASQM1117
https://www.nxtbook.com/naylor/ASQM/ASQM1017
https://www.nxtbook.com/naylor/ASQM/ASQM0917
https://www.nxtbook.com/naylor/ASQM/ASQM0817
https://www.nxtbook.com/naylor/ASQM/ASQM0717
https://www.nxtbook.com/naylor/ASQM/ASQM0617
https://www.nxtbook.com/naylor/ASQM/ASQM0517
https://www.nxtbook.com/naylor/ASQM/ASQM0417
https://www.nxtbook.com/naylor/ASQM/ASQC12518
https://www.nxtbook.com/naylor/ASQM/ASQM0317
https://www.nxtbook.com/naylor/ASQM/ASQM0217
https://www.nxtbook.com/naylor/ASQM/ASQM0117
https://www.nxtbook.com/naylor/ASQM/ASQM1216
https://www.nxtbook.com/naylor/ASQM/ASQM1116
https://www.nxtbook.com/naylor/ASQM/ASQM1016
https://www.nxtbook.com/naylor/ASQM/ASAC0016
https://www.nxtbook.com/naylor/ASQM/ASQM0916
https://www.nxtbook.com/naylor/ASQM/ASQA0016
https://www.nxtbook.com/naylor/ASQM/ASQM0816
https://www.nxtbook.com/naylor/ASQM/ASQM0716
https://www.nxtbook.com/naylor/ASQM/ASQM0616
https://www.nxtbook.com/naylor/ASQM/ASQM0516
https://www.nxtbook.com/naylor/ASQM/ASQM0416
https://www.nxtbook.com/naylor/ASQM/ASQM0316
https://www.nxtbook.com/naylor/ASQM/ASQM0216
https://www.nxtbook.com/naylor/ASQM/ASQM0116
https://www.nxtbook.com/naylor/ASQM/ASQM1215
https://www.nxtbook.com/naylor/ASQM/ASQM1115
https://www.nxtbook.com/naylor/ASQM/ASQM1015
https://www.nxtbook.com/naylor/ASQM/ASQM0915
https://www.nxtbook.com/naylor/ASQM/ASQM0815
https://www.nxtbook.com/naylor/ASQM/ASQM0715
https://www.nxtbook.com/naylor/ASQM/ASQM0615
https://www.nxtbook.com/naylor/ASQM/ASQM0515
https://www.nxtbook.com/naylor/ASQM/ASQM0315
https://www.nxtbook.com/naylor/ASQM/ASQM0215
https://www.nxtbook.com/naylor/ASQM/ASQM0115
https://www.nxtbook.com/naylor/ASQM/ASQM1214
https://www.nxtbook.com/naylor/ASQM/ASQM1114
https://www.nxtbook.com/naylor/ASQM/ASQM1014
https://www.nxtbook.com/naylor/ASQM/ASQM0914
https://www.nxtbook.com/naylor/ASQM/ASQM0814
https://www.nxtbook.com/naylor/ASQM/ASQM0714
https://www.nxtbook.com/naylor/ASQM/ASQM0614
https://www.nxtbook.com/naylor/ASQM/ASQM0514
https://www.nxtbook.com/naylor/ASQM/ASQM0414
https://www.nxtbook.com/naylor/ASQM/ASQM0314
https://www.nxtbook.com/naylor/ASQM/ASQM0214
https://www.nxtbook.com/naylor/ASQM/ASQM0114
https://www.nxtbook.com/naylor/ASQM/ASQM1213
https://www.nxtbook.com/naylor/ASQM/ASQM1113
https://www.nxtbook.com/naylor/ASQM/ASQM1013
https://www.nxtbook.com/naylor/ASQM/ASQM0913
https://www.nxtbook.com/naylor/ASQM/ASQM0813
https://www.nxtbook.com/naylor/ASQM/ASQM0713
https://www.nxtbook.com/naylor/ASQM/ASQM0613
https://www.nxtbook.com/naylor/ASQM/ASQM0513
https://www.nxtbook.com/naylor/ASQM/ASQM0413
https://www.nxtbook.com/naylor/ASQM/ASQM0313
https://www.nxtbook.com/nxtbooks/naylor/ASQM0213
https://www.nxtbook.com/nxtbooks/naylor/ASQM0113
https://www.nxtbook.com/nxtbooks/naylor/ASQM1212
https://www.nxtbook.com/nxtbooks/naylor/ASQM1112
https://www.nxtbook.com/nxtbooks/naylor/ASQM1012
https://www.nxtbook.com/nxtbooks/naylor/ASQM0912
https://www.nxtbookmedia.com