2016 FDA Final Guidance for Blood Glucose Monitoring Systems - Implementation

M

missjenny

#1
So, after issuing the draft versions in 2014, FDA has finalized the guidances for blood glucose monitoring systems just a couple of days ago.

My question is, will these be applicable to 510(k) submissions that are currently being reviewed officially or unofficially?

Are there any past comments from the FDA or precedents or experiences that you might have had regarding the finalization or introduction of a new guidance in the midst of a reviewing process?
 
Elsmar Forum Sponsor
P

Pearce

#2
Jenny,

This isn't exactly what you asked about but it's related and I thought I'd share it.

I asked the FDA about whether a Special 510(k) submission based on previously cleared meters would be accepted and I received the following response:

Future BGMS or SMBG devices, or future modifications to currently cleared BGMS and SMBG devices, should be developed according to the recommendations in the finalized guidance documents.

Hope this helps somewhat.
 
M

missjenny

#3
Thank you for sharing your communication with the FDA.

However, this seems strange to me as Appendix II of the final guidance clearly states that special 510(k) may continue to be submitted with only validation in regards to the parts being modified of own previously cleared meters as long as the meters share the same fundamental scientific technology.

Did the they mention anything in regards to this by any chance?
 
Thread starter Similar threads Forum Replies Date
Sam Lazzara Medical Device File (MDF per 13485:2016 4.2.3) versus FDA Device Master Record (DMR) ISO 13485:2016 - Medical Device Quality Management Systems 3
E MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP Canada Medical Device Regulations 9
B Classes/ Online Training on ISO 13485:2016 and FDA QSR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 5
shimonv Summary of FDA Guidance on “Medical Device Accessories” (Dec 2016) Other US Medical Device Regulations 1
Marc New FDA Cybersecurity Guidelines for Medical Devices (Dec 2016) Other US Medical Device Regulations 0
Q FDA To Publish Powdered Glove Ban Monday (December 19, 2016) Other US Medical Device Regulations 0
P FDA's deadline for IEC 60601-1 3.1 edition compliance - Aug 1, 2016 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
S Electronic Signatures - Non-Conformance - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 27
P IATF 16949:2016 Letter of conformity IATF 16949 - Automotive Quality Systems Standard 5
D Question regarding where "validations" fit according to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
D Question on using audit checklist ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 20
chris1price ISO13485: 2016 Amendment coming? ISO 13485:2016 - Medical Device Quality Management Systems 13
M Customer Property - ISO 13485:2016 Clause 7.5.10 ISO 13485:2016 - Medical Device Quality Management Systems 9
J The necessity and benefit of ISO13485:2016 for a manufacturer of class I devices ISO 13485:2016 - Medical Device Quality Management Systems 3
H QMS ISO 13485:2016 - ISO14971 IEC60304 etc ISO 13485:2016 - Medical Device Quality Management Systems 6
B Operational Procedures for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 7
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO13485:2016, MDSAP and Internal Audits ISO 13485:2016 - Medical Device Quality Management Systems 8
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 4
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 8
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 3
O Informational Ford Motor Company Customer Specific Requirements for IATF 16949:2016 - 08 Jan 2021 Customer and Company Specific Requirements 0
Louddogsbark When your 13485:2016 certificate has been pulled ISO 13485:2016 - Medical Device Quality Management Systems 2
O Release of Sanctioned Interpretations (SIs) related to Rules 5th Edition and Sanctioned Interpretations related to IATF 16949:2016 IATF 16949 - Automotive Quality Systems Standard 0
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
K Comparison wanted: ISO 15378:2018 vs. PS9000:2016 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 13485:2016 Complaint Definition Clarity Customer Complaints 2
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
E 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 3
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
M MDSAP and 13485:2016 gap analysis Quality Management System (QMS) Manuals 1
Q AS9100:2016 D - Intent of 8.4.3 (K) - Implement QMS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
H ISO 13485:2016 Gap Analysis by NB ISO 13485:2016 - Medical Device Quality Management Systems 7
I IATF 2016 - 8.5.1.4 Verification after shutdown due to COVID19 Process Maps, Process Mapping and Turtle Diagrams 1
J PPE, the MDR and EU 2016/425 EU Medical Device Regulations 4
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 9
sutie How to understand VDA 6.3 2016 P4.1 VDA Standards - Germany's Automotive Standards 6
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2

Similar threads

Top Bottom