Regulations and Standards

Early Feasibility Medical Device Clinical Studies


Posted in Regulatory and Compliance by Camilla Andersson on January 19, 2012

US FDA recently issued important draft guidance that describes new approval policies for early feasibility medical device clinical studies of significant risk devices. This article discusses the draft guidance and pilot programme that US FDA has initiated for testing the new policies.


US FDA recently issued several important draft guidance documents regarding the conduct of medical device clinical studies in the United States. On 15 August 2011, the agency issued a draft guidance document on design considerations for pivotal clinical studies for medical devices,1 which describes various study design principles relevant to the development of medical device clinical studies that can be used to fulfil premarket clinical data requirements. On 10 November 2011, US FDA issued draft guidance that describes proposed methods for allowing a clinical study to begin under certain circumstances, even when there are outstanding issues regarding study approval application.2 On the same date, US FDA also issued draft guidance on the development and review of Investigational Device Exemption (IDE) applications for early feasibility studies of significant risk devices.3 US FDA approval of an IDE application is required before a sponsor is allowed to conduct a clinical study with a significant risk device. The regulations governing this process are contained in 21 CFR Part 812, Investigational Device Exemptions.

This article discusses draft guidance on early feasibility studies. The guidance should be of interest to companies developing innovative medical devices that are considered a significant risk by US FDA, where device development would benefit from early clinical studies in the United States that would provide proof of principle and initial clinical safety data. Thus, companies developing such devices should carefully review the draft guidance document to determine whether the proposed policies will meet their needs or whether they can suggest modifications for improvement. Comments should be submitted to US FDA by 8 February 2012 to be considered during development of the final version of the guidance document. The process of submitting comments is described on the US FDA website (www.fda.gov) and also in the Federal Register notice announcing the availability of the guidance document.4 The early feasibility study pilot programme is discussed later.

Early feasibility study draft guidance
Early feasibility study draft guidance is a 28-page document intended to facilitate the early clinical evaluation of medical devices in the United States under the IDE regulations, using risk mitigation strategies that appropriately protect human subjects in early feasibility studies. It contains detailed advice regarding the manner in which companies should seek approval of an IDE for an early feasibility study. The guidance has the following major sections:

  1. Introduction
  2. Overview
  3. Regulatory Background
  4. Targeting Approval for an Early Feasibility Study IDE Application
  5. Report of Prior Investigations
  6. Investigational Plan
  7. Iterations During Early Feasibility Studies
  8. Next Steps in Clinical Evaluation
  9. Conclusion
  10. Appendix 1: Device Evaluation Strategy Example
  11. Appendix 2: Device Iteration Example

Sections 1 and 2 (Introduction and Overview) define and discuss the scope of the guidance and what US FDA considers to be early feasibility clinical studies. Section 3 (Regulatory Background) discusses the relevant sections of the US Food, Drug and Cosmetic Act and IDE regulations. Section 4 (Targeting Approval for an Early Feasibility Study IDE Application) describes the overall process of ensuring that the information in the IDE application is appropriate for early feasibility studies. It also describes the proposed new policy of basing approval of an IDE application for an early feasibility study on less nonclinical data than would be expected for a traditional feasibility study. Section 5 (Report of Prior Investigations) provides very detailed guidance on the type of information that should be provided in an IDE application for early feasibility clinical studies. Section 6 (Investigational Plan) emphasises the need for a thorough risk analysis and risk mitigation strategies. Section 7 (Iterations during Early Feasibility Studies) describes the new policies intended to directly facilitate the timely implementation of changes to the investigational device or clinical protocol. Section 8 (Next Steps in Clinical Evaluation) describes actions that sponsors can take after obtaining clinical information from early feasibility studies depending upon the stability of the device design, availability of adequate data to justify the next study, and purpose of that clinical study. Section 9 (Conclusion) emphasises the importance of a high degree of interaction between US FDA and the sponsor and use of the pre-IDE process in ensuring successful implementation of the guidance.

Appendix 1 provides an example of a device evaluation strategy, discussed in subsection 5.2.2, which could be submitted as a pre-IDE to obtain US FDA feedback on the overall device development plan by identifying the types of information or levels of testing that may be needed to move beyond the early feasibility study. Appendix 2 includes examples of the types of changes that may be appropriate for five-day notification during an early feasibility study as discussed in subsection 7.1, Changes requiring FDA notification (five-day notice), and contingent approval as described in subsection 7.2, Changes requiring FDA approval.

Draft guidance definition of early feasibility studies
The new policies described in the draft guidance apply to early feasibility studies only. Companies evaluating the potential usefulness of the policies for their own device studies should ensure that US FDA agrees that the studies are early feasibility studies.

The Introduction to the draft guidance document defines various types of clinical studies based on US FDA’s current thinking.

  • Early feasibility study: Limited clinical investigation of a device early in development, typically before the device design has been finalised, for a specific indication (an innovative device for a new or established intended use or a marketed device for a novel clinical application, for example). It may be used to evaluate the device design concept with respect to basic safety and device functionality in a small number of subjects (generally fewer than 10 initial subjects), when this information cannot be readily provided through additional nonclinical assessments or appropriate nonclinical tests are unavailable. Information obtained from an early feasibility study may guide device modifications. An early feasibility study does not necessarily involve the first clinical use of a device.
  • First in human (FIH) study: Type of study in which a device for a specific indication is evaluated for the first time in human subjects. This document only discusses FIH studies that meet the definition of an early feasibility study.
  • Traditional feasibility study: Clinical investigation that is commonly used to capture preliminary safety and effectiveness information on a near-final or final device design to adequately plan an appropriate pivotal study. As compared to an early feasibility study, more nonclinical (or prior clinical) data are necessary for approval to initiate a traditional feasibility study; however, a traditional feasibility study does not necessarily need to be preceded by an early feasibility study.
  • Pivotal study: Clinical investigation designed to collect definitive evidence of the safety and effectiveness of a device for a specified intended use, typically in a statistically justified number of subjects. It may or may not be preceded by an early and/or traditional feasibility study.

The Introduction also provides additional useful information concerning not only what early feasibility studies are, but also what they are not. For example, the draft guidance points out that these studies are not intended to generate definitive data to independently support a marketing application in place of a pivotal clinical study. This is an important point because some companies believe the marketing clearance or approval can be obtained from data generated from early feasibility studies.
This section of the draft guidance also states that early feasibility studies have a broader purpose than traditional feasibility studies, which are intended to provide initial safety and effectiveness information for a near final or final device design or generate data to guide the development of a pivotal clinical study. By contrast, the draft guidance states that the clinical experience obtained from an early feasibility study increases the efficiency of the device development process, as this experience may be used to:

  • identify appropriate modifications to the procedure or device
  • optimise operator technique
  • refine the intended-use population
  • refine nonclinical test plans or methodologies and develop subsequent clinical study protocols.

Additional guidance is also provided on how to determine whether a clinical study falls into the early feasibility, traditional feasibility or pivotal category. To avoid preventable delays, the guidance also advises contacting US FDA before an IDE submission to determine whether the proposed investigation can be classified as an early feasibility study.

Early feasibility study IDE pilot programme

In a 10 November 2011 Federal Register (FR) Notice,5 US FDA announced that it was requesting nominations of sponsors of innovative device technologies to participate in a pilot programme for early feasibility study IDE applications conforming to the policies outlined in the newly issued draft guidance on early feasibility study IDEs. The FR notice states that US FDA began accepting nominations for participation in the pilot programme on 12 December 2011.

The agency believes that the benefits of participating in the pilot programme include facilitating development of innovative products in the United States and evaluating the new approaches for modifications made during early feasibility studies, as specified in the early feasibility study draft guidance. Information gained during the pilot programme will be considered during development of the final guidance document.

Because of US FDA resource constraints, the programme will be limited to nine sponsors. Companies interested in participating in the programme should inquire without delay following the procedures specified in the FR notice. 

References
1.    Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff - Design Considerations for Pivotal Clinical Investigations for Medical Devices (15 August 2011); www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments....
2.    Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff - FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations (10 November 2011); www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments....
3.    Draft Guidance for Industry and Food and Drug Administration Staff - Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies (10 November 2011); www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments....
4.    US Federal Register Notice: Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Availability (10 November 2011); FR Doc. 2011-29117; Vol. 76, No. 218, pages 70150-70151; www.gpo.gov/fdsys/pkg/FR-2011-11-10/pdf/2011-29117.pdf.
5.    US Federal Register Notice: Pilot Program for Early Feasibility Study Investigational Device Exemption Applications (10 November 2011); www.gpo.gov/fdsys/pkg/FR-2011-11-10/pdf/2011-29116.pdf.

Maria E. Donawa,
Donawa Lifescience Consulting, Piazza Albania 10, I-00153 Rome, Italy
tel. +39 0 6578 2665  |  Maria Donawa  |  www.donawa.com
A physician, pathologist and pharmacist with nearly 30 years’ regulatory experience, Maria E. Donawa worked with US FDA before becoming President of what is now Donawa Lifescience Consulting, a full service European CRO and international consultancy company that provides regulatory, quality and European Authorised Representative services to life science companies.



Find more content on:
No votes yet


Login to post comments

Comment viewing options

Select your preferred way to display the comments and click "Save settings" to activate your changes.

I have read your article, it

I have read your article, it is very informative and helpful for me.I admire the valuable information you offer in your articles. Thanks for posting it.
Link building service
https://www.fiverr.com/brayden_ben/manual-do-50-blog-comments-on-actual-...

This is also a very good post

This is also a very good post which I really enjoyed reading. It is not every day that I have the possibility to see something like this.
window cleaning in idaho falls
http://www.allshine-idaho.com/idaho-falls-window-cleaning/

dr horton home warranty

I just got to this amazing site not long ago. I was actually captured with the piece of resources you have got here. Big thumbs up for making such wonderful blog page.
lennar home warranty
home warranty of america promotion code
dr horton home warranty

There are a lot of expensive

There are a lot of expensive programs out there you can buy in order to lose weight and get in better shape, but what most fail to realize is that the proper information can help achieve those same results. So before you go spend big on programs, take a few minutes to read these great weight-loss tips. More details on Old School New Body review site.

If you absolutely must

If you absolutely must indulge in something sweet, have a glass of decaffeinated coffee with it. This will help lower the spike in blood sugar you get after eating, potentially stopping the need for you to inject more insulin. It must be decaf, though, as caffeine can have other, unwanted side effects. Click Here

There are holes in a college

There are holes in a college opinion that defend specifically on present stocks. Bailiwick canada is disunite of those. Impecunious trepidation of intimate, this treatises could creak the political stride near us. This is the tremendous mend in cyber mold. Mike Ramsey

I want you to thank for your

I want you to thank for your time of this wonderful read!!! I definately enjoy every little bit of it and I have you bookmarked to check out new stuff of your blog a must read blog!! Obsession Phrases PDF

The process of submitting

The process of submitting comments is described on the US FDA website (www.fda.gov) and also in the Federal Register notice announcing the availability of the guidance document.4 The early feasibility study pilot programme is discussed later.clash of clans cheats android . pou infinito

The regulations governing

The regulations governing this process are contained in 21 CFR Part 812, Investigational Device Exemptions.Watch Fear The Walking Dead Episode 1 Online

Post. We are really grateful

Post. We are really grateful for your blog post. You will find a lot of approaches after visiting your post. agen judi bola

blog post. You will find a

blog post. You will find a lot of approaches after visiting your post.. car from delhi to jaipur

The regulations governing

The regulations governing this process are contained in 21 CFR Part 812, Investigational Device Exemptions.Read More

I found your this post while

I found your this post while searching for some related information on blog search...Its a good post..keep posting and update the information.
twitter.com

David John

I was very pleased to find this site.I wanted to thank you for this great read!! nursing homes hiring I definitely enjoying every little bit of it and I have you bookmarked to check out new stuff you post.

I also benefit from learning

I also benefit from learning the assessments, but learn that alot of people ought to stay on essay to try and add worth in the direction of the authentic weblog release. water damage restoration houston

Yugoslavia bombing of

Yugoslavia bombing of civilians were illegal, the practices by USG-Hillary Clinton in regime change are illegal, packers and movers in pune

US FDA recently issued

US FDA recently issued several important draft guidance documents regarding the conduct of medical device clinical studies in the United States.how to get instagram followers free | how to get fake likes on instagram

The guidance should be of

The guidance should be of interest to companies developing innovative medical devices that are considered a significant risk by US FDA, where device development would benefit from early clinical studies in the United States that would provide proof of principle and initial clinical safety data. Lady Secret Cream

This is a great post. I like

This is a great post. I like this topic.This site has lots of advantage.I found many interesting things from this site. It helps me in many ways.Thanks for posting this again.
Curious George

David John

Your web log isn’t only useful but it is additionally really creative too. There tend to be not many people who can certainly write not so simple posts that artistically. the venus factor review

This article discusses the

This article discusses the draft guidance and pilot programme that US FDA has initiated for testing the new policies.Hitman: Agent 47 (2015) MovieTube

The regulations governing

The regulations governing this process are contained in 21 CFR Part 812, Investigational Device Exemptions.how to get rid of love handles fast

cutting technology is

cutting technology is described here that produces smooth apertures and eliminates problems associated with debris
click here top page google

Thank you for some other

Thank you for some other informative blog. Where else could I get that type of information written in such an ideal means? I have a mission that I’m just now working on, and I have been at the look out for such information.
http://www.memyfriends.com/how-to-get-a-hot-girlfriend-if-youre-ugly/

Hello! I just want to give a

Hello! I just want to give a huge thumbs up for the great info you have here on this blog. I will be coming back aimed at your website for additional soon.
http://www.ccs-europe.com/how-do-i-get-a-girl-that-is-playing-hard-to-get/

Thanks you very much for

Thanks you very much for sharing these links. Will definitely check this out..
https://rebelmouse.com/bloodpressurecurereviews/

I’m impressed by the details

I’m impressed by the details that you¡¦ve on this web site. It reveals how nicely you understand this subject. Bookmarked this web page, will come back for extra articles. You, my friend, ROCK! I found simply the information I already searched all over the place and simply couldn’t come across. What a perfect web-site.
STOIXIMA

I recently came across your

I recently came across your blog and have been reading along. I thought I would leave my first comment. I don't know what to say except that I have enjoyed reading. Nice blog. I will keep visiting this blog very often.
Capture his heart program guide

Wow! This could be one of the

Wow! This could be one of the most useful blogs we have ever come across on thesubject. Actually excellent info! I’m also an expert in this topic so I can understand your effort.
Mitsubishi

what is the best home warranty company

A very awesome blog post. We are really grateful for your blog post. You will find a lot of approaches after visiting your post. I was exactly searching for. Thanks for such post and please keep it up. Great work.
what is the best home warranty company
choice home warranty vendor login
best home warranty company in texas

Wonderful illustrated

Wonderful illustrated information. I thank you about that. No doubt it will be very useful for my future projects. Would like to see some other posts on the same subject!
Coconut Oil Secret Book Review

Hello, I have browsed most of

Hello, I have browsed most of your posts. This post is probably where I got the most useful information for my research. Thanks for posting, maybe we can see more on this. Are you aware of any other websites on this subject.
visit here

Thanks for taking the time to

Thanks for taking the time to discuss that, I feel strongly about this and so really like getting to know more on this kind of field. Do you mind updating your blog post with additional insight? It should be really useful for all of us.
check this website

Good post but I was wondering

Good post but I was wondering if you could write a litte more on this subject? I’d be very thankful if you could elaborate a little bit further. Appreciate it!
how to get a free minecraft account

Positive site, where did u

Positive site, where did u come up with the information on this posting?I have read a few of the articles on your website now, and I really like your style. Thanks a million and please keep up the effective work.
click here

Fantastic blog! Do you have

Fantastic blog! Do you have any tips and hints for aspiring writers? I’m planning to start my own website soon but I’m a little lost on everything. Would you propose starting with a free platform like WordPress or go for a paid option? There are so many options out there that I’m completely overwhelmed .. Any suggestions? Many thanks!
check this site

On the off chance that you

On the off chance that you have somebody who can control you on your way while you utilize these approaches to profit quick you will be significantly more inclined to succeed and quicker as well. Thus, please take in more data, please click here. check this website

songs information once

songs information once uploaded, is because the names in our file system and for the voting permalinks, are based on the information you provide when going through the upload process. If you make a mistake with spelling, the only recourse is to delete the song and upload the song again. blog comments back links

be regulated by both,

be regulated by both, depending on the method of action, i.e. how the drug is administered to the end user through the device. If the drug system is active in a pharmacological mode of action then the Orange Guide would be applied. cheap price backlinks

Thank you so much for sharing

Thank you so much for sharing this great blog.Very inspiring and helpful too.Hope you continue to share more of your ideas.I will definitely love to read.

chessboard

If more people that write

If more people that write articles really concerned themselves with writing great content like you, more readers would be interested in their writings. Thank you for caring about your content.
Official website

I was reading your article

I was reading your article and wondered if you had considered creating an ebook on this subject. Your writing would sell it fast. You have a lot of writing talent.
Ipage.com review 2015

Wonderful blog! I found it

Wonderful blog! I found it while surfing around on Yahoo News. Do you have any suggestions on how to get listed in Yahoo News? I’ve been trying for a while but I never seem to get there! Appreciate it.
Minecraft gift code generator

Thank you for taking the time

Thank you for taking the time to publish this information very useful!
Miracle Pregnancy

Superbly written article, if

Superbly written article, if only all bloggers offered the same content as you, the internet would be a far better place..
Acne no more reviews

Thanks for taking the time to

Thanks for taking the time to discuss this, I feel strongly that love and read more on this topic. If possible, such as gain knowledge, would you mind updating your blog with additional information? It is very useful for me.
football betting profit

I wish more authors of this

I wish more authors of this type of content would take the time you did to research and write so well. I am very impressed with your vision and insight.
click here for info

Impressive web site,

Impressive web site, Distinguished feedback that I can tackle. Im moving forward and may apply to my current job as a pet sitter, which is very enjoyable, but I need to additional expand. Regards.

online payday loans

Thank you for some other

Thank you for some other informative blog. Where else could I get that type of information written in such an ideal means? I have a mission that I’m just now working on, and I have been at the look out for such information.
click here for info

Thanks you very much for

Thanks you very much for sharing these links. Will definitely check this out..
Rebel Mouse