The 2014 (Paper) CRA Handbook Is Here!
A Medical Device Handbook for Regulatory and Clinical Research Professionals
A Promotional Piece by Nancy J Stark, PhD.
The CRA Handbook was the first "book" I ever edited. I was jealous because, at the clinical and regulatory conferences I attended, little books of Part 312 for pharmaceutical clinical investigations were handed out for free by the vendors. But there was nothing available for the poor Cinderella of medical devices. To balance the scales, I wrote my own handbook for device clinical and regulatory professionals and added some extra reference materials to make it even more useful.
Devices Are Different from Drugs
If you work in the medical device world, you know that good clinical practices for devices are vastly different from pharmaceuticals in implementation.
Size and Storage of Investigational Products
The first big difference is with size and storage. Once I had a device the size of a breadbox. The IRB insisted the pharmacy keep the investigational breadbox-sized devices under double-lock and key, as was their practice with investigational drugs. But pharmacies don't have storage room for 100 breadboxes, and pharmacies don't dispense medical devices. The investigator had storage room, but no double-locked box for large devices. After weeks of negotiation--and costly delays to the investigation--the IRB agreed to allow the investigator to store the large devices in her office with a single lock on the door. The unique storage requirements of devices is unfamiliar to drug folks.
CRA Handbook 2014
I use the CRA Handbook as a desk reference for US regulations, a list of guidances, and regulatory and clinical requirements. When I traveled, I used it as a reference tool during meetings and for late-night hotel work. By the end of the year, my copy was dog-eared, filled with annotations, and colorful with Post-It tags. All my favorite paragraphs were marked. To learn more, go here.
Initiation of Investigations
The second big difference is that there are two levels of approval for study initiation in devices. In the US, device clinical investigations may be conducted under the abbreviated IDEs or under full IDEs (Investigational Device Exemptions). Abbreviated IDE studies make up 80-90% of the clinical investigations in the States, do not require FDA approval for initiation, and do not require a final report to FDA. There is no registry or list of abbreviated IDE studies. I'm getting my numbers from private interviews; for example, manufacturers of dermal contact products might do 100 clinical investigations a year on healthy, volunteer employees. While full IDE studies get all the attention, so-called 'non-IDE' studies are confusing to drug folks.
Adverse Effect Reporting
The third big difference between device and pharmaceutical investigations is with reporting of adverse effects and events. Adverse effects are device related, adverse events are not. Unless otherwise specified by the protocol, only USADEs (unanticipated, serious, adverse device effects) are reported to FDA. Not reporting anticipated adverse effects to FDA is befuddling to drug folks.
What's New in the 2014 Edition?
Two major things changed in the regulatory world since 2011 and are reflected in the 2014 edition of the Handbook. The Declaration of Helsinki was updated to reflect the changes made in by the World Health Association in 2013, and 21 CFR Part 812.119 on investigator disqualification was expanded and strengthened. What's missing?
Should we add other documents to the Handbook to make it more useful to you? Tell us what to add.
The Table of Contents
01 CFR Part 812-Investigational Device Exemptions
02 CFR Part 812.20-Premarket Approval Applications
03 CFR Part 11-Electronic Records: Electronic Signatures
04 CFR Part 50-Protection of Human Subjects
05 CFR Part 54-Financial Disclosure
06 CFR Part 56-Institutional Review Boards
07 CFR Part 99-Dissemination of Information
08 CFR Part 809-In Vitro Diagnostic Products
09 CFR Part 820.30-Quality System--Design Controls
10 Expedited Review List
11 Risk Based Monitoring--The New FDA Guidance
12 Declaration of Helsinki (2013)
14 ISO 14155 (2011) Summary
15 Adverse Events and Effects
16 FDA Guidances
How do I get one?
Go to our website.
The electronic version of the handbook is in the works.
Julie is editing as fast as she can to get the electronic copy updated, functional, with working links and pretty colors. She expects it to be completed by June 2014. If you would like to be notified when it is ready, contact Peggy and have your name added to a notice list.
Nancy J Stark, PhD
President, Clinical Device Group Inc
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