Is FCC required for Medical Equipment without Radio Frequency Energy?

Roland chung

Trusted Information Resource
#1
Hello all,

FCC PART 18 and PART 15 seems to be appropriate to radio frequency device only. The product concerned is medical suction equipment which consists of DC pump and approved stand alone power supply. The agent told me that FCC should be considered if the product intended to be sold in the US market.

I am totally confused. Could anyone help to clarify it? Is there a FCC training stuff? As I am quite new to the FCC.

Thanks and regards,
Roland
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
As far as I know, if you've established from physical principles, engineering knowledge and testing if required that your device does not emit RF energy, you would memo-to-file that decision process and subsequently regard FCC regulation as not applicable to your device.

However: how does your power supply work? If it's switching type, usually it needs to be engineered to not have unacceptable RF emissions and to be classifiable so that the applicable regulations are those for your intended use rather than a stricter set. It might need additionally to be evaluated and tested to verify compliance. If your "approved" status already incorporates all of that, you're good to go. Otherwise, maybe not.
 

Roland chung

Trusted Information Resource
#3
MIREGMGR, thank you for your input.

From your point of view, it seems that medical equipment employed switching power supply needs to meet FCC regulations. Is there an official statement?

So far as I know, none FDA guidance documents mention FCC requirement. Generally, IEC60601-1-2 (EMC) is recommended by FDA.

Actually, I am also wondering if medical equipment has been FDA clearanced is sufficient from the regulation point. For OSHA and FCC, how they function?
 
M

MIREGMGR

#4
FCC and FDA have no interaction or cross requirements. FDA clearance is irrelevant as far as FCC is concerned. Same with OSHA.

IEC 60601-1 is a standard providing for patient and user safety, etc. It has nothing to do with management of the RF spectrum, which is what FCC does.

As to written rules, start at the FCC website.

RF emitting equipment of any kind has to meet FCC rules in USA. Whether it is medical equipment is irrelevant, other than consideration of the intended use of the equipment and therefore what rules apply to it, i.e. consumer equipment has one set of rules, business equipment another, industrial equipment a third. Equipment that isn't intended to emit RF as part of its function is governed differently from, say, an RF welder or radio transmitter.

Power supplies are not intended to emit RF, therefore the rules generally don't allow them to do so in excess of certain limits.
 
Thread starter Similar threads Forum Replies Date
M CE/FCC/Industry Canada - Standards required for Certification for a Bluetooth Device CE Marking (Conformité Européene) / CB Scheme 6
R New product testing for CE marking - Required FCC testing CE Marking (Conformité Européene) / CB Scheme 4
thisby_ EMC/FCC part 15 test (NRTL - Nationally Recognized Testing Laboratories) required? US Food and Drug Administration (FDA) 1
R FCC certification (contract manufacturer) TL 9000 Telecommunications Standard and QuEST 1
J Medical System with non-medical device and FCC US Food and Drug Administration (FDA) 5
E Doubts about the FCC regulations for the use of Bluetooth in medical equipment Other Medical Device Related Standards 3
M CE / FCC Compliance for components + final product CE Marking (Conformité Européene) / CB Scheme 2
E Bluetooth Data Transmission Levels - FCC ITU Levels Other Medical Device Related Standards 0
Marc FCC boss says he'll SHAME broadband firms for fibbing on speeds After Work and Weekend Discussion Topics 0
D FCC and ICES Markings for EMC Compliance of Class 1 Medical Device Other US Medical Device Regulations 2
S FCC Rules for Hospital Wireless Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
W Do FCC regulations apply for Medical Devices other than EMC? US Food and Drug Administration (FDA) 3
Marc iPad FCC Teardown and Analysis with photos After Work and Weekend Discussion Topics 4
C FDA Approved Ultrasonic Equipment - FCC Requirements for US sales US Food and Drug Administration (FDA) 4
amjadrana Medical Device EMC requirements - Canada - Testing to FCC part 18, EN 55011, EN 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Device functionality over service life - Objective evidence required? Design and Development of Products and Processes 10
M Quality management certification required by Health Canada Canada Medical Device Regulations 3
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 3
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
A Question on ISO 14001:2015 - Are annual audits required? ISO 14001:2015 Specific Discussions 8
M Is Validation of Plating Processes required and who is responsible? Qualification and Validation (including 21 CFR Part 11) 11
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
O ISO 13485 - Is management review required before stage 1? ISO 13485:2016 - Medical Device Quality Management Systems 6
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
V Manufacturing requirements for respiratory ventilators - clean room required? Medical Device and FDA Regulations and Standards News 6
A When there is a 2 year lapse in production, is a full FAI required? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
C Is it required to put"Rx only" on the home page of an app? Medical Device and FDA Regulations and Standards News 4
B IEC 60601-2-10 - Accuracy of Pulse Parameters - Required Measurement Uncertainty IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Is Optical Parallel Set required calibration? ISO 17025 related Discussions 1
R Is it required to have an SOP for external audits? Medical Device and FDA Regulations and Standards News 7
M MDR - Is a formal GSPR Procedure required? EU Medical Device Regulations 20
M When is FAI required? AS9100 8.5.1.3 and 8.4.3 requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 9
B IATF 16949 - Is a Deviation required for sample components in a prototype build? IATF 16949 - Automotive Quality Systems Standard 13
J MDD to MDR transition - Time required for the implementation of the MDR EU Medical Device Regulations 7
Robert Stanley Required Documentation Templates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M ISO 9001:2015 8.2.1 Contingency Plan required for small Business? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M MDR - Under what circumstances is a PMCF not required? EU Medical Device Regulations 1
B AIAG-VDA FMEA - When the new format will be required FMEA and Control Plans 5
MrTetris Are GLP required for testing cytotoxicity and soil remaining after sterilization of MD? Other Medical Device Related Standards 8
Z EN 868-8 "required tests" - Rigid sterilization containers Other Medical Device Related Standards 0
D Design Verification - Is testing required? Design and Development of Products and Processes 5
M User manual / instructions for use for class II device always required? Medical Device and FDA Regulations and Standards News 3
A Calibration required by OEM General Measurement Device and Calibration Topics 2
S How many mandays required for the below mentioned standards IEC 27001 - Information Security Management Systems (ISMS) 3
S Examples of software changes that required a 510k US Food and Drug Administration (FDA) 2
D Required Checklist Showing Compliance to IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 11
C ETO Sterilised Class II Medical Device - Required Temperature Storage ISO 13485:2016 - Medical Device Quality Management Systems 1
P 21 CFR 807.81 When a premarket notification submission is required Other US Medical Device Regulations 0
Similar threads


















































Top Bottom