The likelihood of approval by the FDA for a Class II Medical Device

invitro_spain

Involved In Discussions
#1
Hi Folks,

Is there any way to calculate the likelihood of approval by the FDA for a medical device class II?

Do you have any advice?

Thank you in advance
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Re: Likelihood of approval by the FDA in medical device

I saw a statistic once that something like close to 70% of submissions were rejected right out of the gate (received the dreaded RTA - Refuse to Accept). (And of course that doesn't take into account those that are rejected after the review process begins). I don't know if that's true or still the case, but it should give you an idea that it's not a cake walk by any means.

Having a seasoned regulatory consultant can help. Having a seasoned regulatory consultant that specializes in the type of device (i.e., has successfully gotten similar devices through the process) is even better.
 

Edward Reesor

Trusted Information Resource
#3
Re: Likelihood of approval by the FDA in medical device

I was at a conference a few years ago and a winner of an innovative medical device was doing a Q&A about his product. At the time, his company felt that the FDA process was too prohibitive despite the calculated success of his product, therefore he was avoiding the US market altogether.

Mind you, I have heard from North American manufacturers stating that the EU process (especially now with the new reg's) is just as arduous and they are avoiding or pulling out of the European market in favour of North America.

A suggested solution is to hire a consultant (as stated above) or partner with a North American manufacturer who may have an easier process in place.
 

JeantheBigone

Quite Involved in Discussions
#4
I'm not aware of any way to calculate a probability of success (FDA does not "approve" Class II or Class I devices through the 510(k) process, they "clear" them, which means that they accept your evidence that your device is substantially equivalent in safety and effectiveness to a legally marketed device).

I do know however how to increase the odds in your favor.

1) Do your homework. Find out exactly what FDA expects by reading guidance documents if any, look at summaries of recently cleared devices to see what others have done

2) Provide an RTA checklist in your submission showing the reviewer exactly where to find each and every item. This speeds up the RTA process and shows the reviewer that you are serious about clearance

This minimizes the chance of not passing the RTA hurdle and reduces the likelihood of "Additional Information" requests, which - if they take longer than 180 days to respond to - will end the review.

Yes the 70 % number of RTA rejections was correct, the process has been improved since then. There were some "humdingers" like not stating the level of concern for software for a submission for latex gloves / explicitly stating that latex gloves do not rely on software so that point can be safely ignored.
 

Edward Reesor

Trusted Information Resource
#5
Another key factor: as of January 17, 2017, the FDA changed their policy for "Combination Products" and will require a more rigorous clinical evaluation process. To summarize, if your product is a combination of a predicate device "A" and predicate device "B" (e.g. a stent coated with a drug), you cannot say that it is equivalent based on those two distinct products. Unless there is a predicate device that already has the two components already combined, you have to start from scratch.
 

invitro_spain

Involved In Discussions
#6
Thank you JeantheBigone for clarifying the concepts "approval" and "clearance". The product is class II and we need to submit a 510(k) as you said. I notice that I misused the terms.
 

robert.beck

Involved In Discussions
#7
Re: Likelihood of approval by the FDA in medical device

1. I would like to not believe that statistic, because RTA is easy. it does require attention to detail, but FDA makes it easy if you are awake to get through RTA.

I have yet to have a problem with RTA; I know of one person who failed it but he has dyslexia.

RTA just means that you included the various items, such as a biocompatibility report. it doesn't mean that the included items are any good. for instance, if biocompatibility is supposed to test the patient contact surface and upon reading the report it is clear that device component was not tested, you will not get clearance.

2. Business people generally do not approve of any kind of regulation. I hear this kind of statement often; it means that the company has not figured out how to be successful in the medical device industry and it needs someone to blame. the FDA is a convenient target. recent example: upon failing to log in to an FDA database due to using an incorrect password, the response was "@#!%# FDA" followed by going home early in frustration. Business will take the easiest path; for a given product, if the MDD is easier than QSR it will be Europe. If QSR is easier than MDD, it will be USA.
 
Last edited:

Ajit Basrur

Staff member
Admin
#8
Some additional info:

FDA's Role in Ensuring American Patients Have Access to Safe and Effective Medical Device Technology

Another measure of the performance of the medical device program is that FDA is working with industry to ensure that submissions are complete and ready for review. As a result, the percentage of submissions that are cleared and approved has increased since 2010:

◦The percentage of 510(k)s cleared increased from 73 percent in FY 2010 to 84 percent in FY 2014.

◦The percentage of PMAs approved increased from 59 percent in FY 2010 to 86 percent in FY 2014.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Please let me add that sometimes a 510(k) is "not cleared" not because there's a real problem with the device or because the FDA plays it hard, but because during the review process the submitter becomes aware of some missing piece (eg testing that needs completion, a change in marketing requirements as understood) and for various business reasons decides to abandon the submission. In such a case the time allocated by FDA for the submitter to respond might elapse, and the submission would be rejected on procedural grounds.
 
Thread starter Similar threads Forum Replies Date
Ashok sunder Is it possible to reduce Risk likelihood and impact Post control Ranking after corrective action taken for risk? FMEA and Control Plans 1
F Risk = Likelihood * Severity - Can we mitigate the Severity? Occupational Health & Safety Management Standards 41
M Probability vs. Likelihood in OHSAS 18001 Clause 3.21 Occupational Health & Safety Management Standards 13
L Risk Analysis Question - Estimating the likelihood of a hazard occuring ISO 13485:2016 - Medical Device Quality Management Systems 1
C Looking for a table that quantifies Likelihood/Probability of occurrence of a hazard ISO 13485:2016 - Medical Device Quality Management Systems 3
P Notified Body Approval of Change EU Medical Device Regulations 2
Marcel DS GOST-R (Type approval for Vehicles in Russia) Other ISO and International Standards and European Regulations 0
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
O Radio modular approval in Brazil Other Medical Device Regulations World-Wide 2
O Radio Modular approval in China China Medical Device Regulations 0
dgrainger Clue to UK's new regulatory requirements - approval of all devices placed on the market? Other Medical Device Regulations World-Wide 1
was named killer AS9100 Supplier Approval Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
F How to fill out an Appearance Approval Report (AAR) APQP and PPAP 0
Q Document approval through SharePoint (without signature) Records and Data - Quality, Legal and Other Evidence 4
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Production approval testing - Alternative ideas for Validation Reliability Analysis - Predictions, Testing and Standards 4
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
I Question 1 - Nitpicking on Document Approval - can a document approval record be separate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
F Medical devices_hong kong_post approval changes regulation (China's MOH) Other Medical Device Regulations World-Wide 3
F Medical Devices-South Africa _Post approval changes and Software Other Medical Device Regulations World-Wide 0
C NB approval - Basic question about Notified Bodies and their role EU Medical Device Regulations 10
C AS9145 Appendix D PPAP Approval Form APQP and PPAP 2
N China - Start manufacturing before change approval? China Medical Device Regulations 1
I MSA requirement for 5 Micrometers + CP changes need customer approval? IATF 16949 - Automotive Quality Systems Standard 2
D ROW Approval Matrix Other Medical Device Regulations World-Wide 2
T Clinical trial - Medical device product not cleared (without FDA approval) in a drug trial Other US Medical Device Regulations 9
S Education authority requires approval of all courses - Training services provider ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Can Brazil approval be used for other countries in Latin America? Other Medical Device Regulations World-Wide 2
M Does cFDA accepts FDA approval or CE marking? China Medical Device Regulations 1
S NADCAP approval for Conventional Machining and Chemical processes - need assistance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
DuncanGibbons FAA approval of articles (PMA, TSO) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
M Criteria and when to carry out Setup Approval Manufacturing and Related Processes 5
D Engineering Drawing Review and Approval Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
K ISO 9001 Requirements for Raw Material Supplier Assessment and Approval ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T AS9100 Maintain Approval When Business Ownership Changes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Informational USFDA Guidance – Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) Medical Device and FDA Regulations and Standards News 0
I Document levels and approval requirements for lower level documents like work instructions, forms etc. Document Control Systems, Procedures, Forms and Templates 18
S FDA approval process for medical device US Food and Drug Administration (FDA) 2
Sidney Vianna AS9100 News PPAP in the Aerospace Sector - What is it? AS9145 - Requirements for Advanced Product Quality Planning and Production Part Approval Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
D Changing Templates Approval Field Document Control Systems, Procedures, Forms and Templates 5
Q AS9120B Clause 8.4.1.1 External Providers Scope of Approval AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J IEC 62366 - Ethical approval IEC 62366 - Medical Device Usability Engineering 5
H Informational What is PPAP (Production Part Approval Process)? APQP and PPAP 26
C Approval of raw material suppliers which do not manufacture the material ISO 13485:2016 - Medical Device Quality Management Systems 7
S MDD in 2018 - Company with no previous EU approval EU Medical Device Regulations 1
V Paint batch approval procedure for automotive industry Manufacturing and Related Processes 6
S STPi approval for laptop movement IEC 27001 - Information Security Management Systems (ISMS) 1
R Concessions - ISO 13485:2016 requires concession approval from customers Nonconformance and Corrective Action 2
K Where are Production parts approval specified/required? Misc. Quality Assurance and Business Systems Related Topics 2
E Approval for Templates Document Control Systems, Procedures, Forms and Templates 6

Similar threads

Top Bottom