SBS - The best value in QMS software

Bringing Medical Device Prototypes into the US

Q

qmvpma

#1
Hi,

we are currently developing a class II medical device in europe. To performe some validation tasks, we would like to bring 5 devices to the us.
Are we allowed to just put them in a suitcase and fly to the us or are there any regulation regarding medical device prototypes?

We are planning to start a 510 clearance next year.

thanks in advance
 
Elsmar Forum Sponsor
M

MIREGMGR

#3
Hi,

we are currently developing a class II medical device in europe. To performe some validation tasks, we would like to bring 5 devices to the us.
Are we allowed to just put them in a suitcase and fly to the us or are there any regulation regarding medical device prototypes?
US FDA regards any product that can perform a medical device function as a regulated device, irrespective of whether you regard it as a prototype. A medical device brought into USA is subject to regulation by both FDA and Customs and Border Protection (CBP).

There is a specific exception-category for investigational devices intended to be used for clinical trials and safety-and-effectiveness validation: the Investigational Device Exemption (IDE) program.

See this link and the provided index for further information.

It's not a particularly simple course to follow, but it's the legal way to bring prototype devices into USA if you aren't ready to subject them to full regulation.

A non-Listed, non-IDE medical-device-like product detected at the border by CBP would be subject to seizure.
 
Last edited by a moderator:
J

Julie O

#4
I'm wondering what definition is being used that makes this Thing a medical device?

In my lexicon, if it's a prototype, it is by definition not intended to be used for any of the purposes listed in the FDA's definition of a medical device. That is, if it really is a prototype, rather than an investigational device, which makes Ronen's question a good one, given that a pivotal trial is a form of design validation. But there are other types of validations that are not clinical trials.

Not disagreeing with anyone's answers here, just asking. My personal lexicon has yet to be universally adopted.
 
Thread starter Similar threads Forum Replies Date
S Bringing a Medical Device Sample from a Foreign Country into the US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
T Training recommendations? Bringing our RoHS and REACH compliance efforts in-house REACH and RoHS Conversations 2
Ed Panek Bringing Production In house ISO 13485:2016 - Medical Device Quality Management Systems 10
Ed Panek Bringing Production in house from Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 3
M Bringing blending in-house - Verification or full validation? (Disinfectants) ISO 13485:2016 - Medical Device Quality Management Systems 3
Sidney Vianna IATF bringing stakeholders together to ensure Transition by the 2018-09-14 deadline IATF 16949 - Automotive Quality Systems Standard 10
T AS9104/3 is bringing in a requirement for an AA to qualify as AEA based on Audit Days AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Q Gap Analysis - Bringing a smaller subsidiary company up to IS0 9001:2008 standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C Bringing a Second Office Location into Registration Scope ISO 14001:2015 Specific Discussions 12
C Bringing a CQA Primer Copy for an exam Professional Certifications and Degrees 14
C Bringing Simple Calibrations Back In-House General Measurement Device and Calibration Topics 16
T QMS in place - How to illustrate? Small matter of bringing it into action ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Wes Bucey To sue, or not to sue: That is the question until you are the person bringing suit... Coffee Break and Water Cooler Discussions 73
M (medical device) V&V phase: justification of acceptance criteria (statistical method ?) Design and Development of Products and Processes 0
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 1
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
B Specialized Medical Apparel Manufacturing and Related Processes 1
B Free Sales Certificate for Non Medical Devices Other Medical Device Related Standards 1
M Medical device substance based-leachables Other Medical Device Related Standards 1
K Usability for custom made medical devices IEC 62366 - Medical Device Usability Engineering 4
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
dgrainger Informational MHRA - Regulating medical devices in the UK - Post Brexit - 2021-02 UK Medical Device Regulations 0
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
L Medical Device Registration in Macau Other US Medical Device Regulations 1
A Medical Device Registration in the Dominican Republic Other Medical Device Regulations World-Wide 4
Aymaneh Medical Device Cybersecurity Risk Management IEC 27001 - Information Security Management Systems (ISMS) 2
S Medical watch Class II (AP Type CF) with USB connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T B2C Medical Device Shipping across the US Other Medical Device Related Standards 0
M Medical Device Registration In Malaysia Other Medical Device Regulations World-Wide 2
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
V Sister companies selling same medical device under different names ISO 13485:2016 - Medical Device Quality Management Systems 3
K CE Marking for Class I Medical Device? CE Marking (Conformité Européene) / CB Scheme 7
L Medical device storage conditions ISO 13485:2016 - Medical Device Quality Management Systems 1
F USB powered handheld medical device - Isolation requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
L How to determine / validate Medical Device Storage Conditions ISO 13485:2016 - Medical Device Quality Management Systems 1
M Europe GMP medical devices - Combination products - Ancillary medicinal substance CE Marking (Conformité Européene) / CB Scheme 4
L Shelf life of medical devices Other Medical Device Related Standards 4
P Best european location to set up for a virtual medical device manufacturer? EU Medical Device Regulations 4
Y Possibility for Medical Device registration in Israel Regulation Other Medical Device Regulations World-Wide 4
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
R Classification of USB DC operated medical equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Medical Devices - Ancillary - ISO 10993-17 Medical Device and FDA Regulations and Standards News 6
S How is the service life for class I reusable medical devices described in MDR? EU Medical Device Regulations 7
S How is the service life described for class I reusable medical devices in MDR? Elsmar Xenforo Forum Software Instructions and Help 1
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Determining if an Insulin Pen Testing Machine is a Medical Device? EU Medical Device Regulations 4
M Indian Medical Device Rules - Manufacturing and Wholesale Lic. Required ? Other Medical Device Regulations World-Wide 3
K Medical Device Repairs and ISO Scope ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom