Can we use Third-party 510(k) reviewer?

N

newto510k

#1
In the regulations for when it is acceptable to use a Third-party 510(k) reviewer, it says

The FDA must accredit persons to conduct initial 510(k) reviews no later than one year after enactment. Accredited persons may not review:
- Class III devices;
- Class II devices that are permanent implants or life sustaining or life supporting; or
- Class II devices which require clinical data, except the number in this group must not be more than 6 percent of total submissions (as defined by statute).
My question is about the third bullet - how do you know if your device *requires* clinical data. Are the conditions that describe this stated in a guidance or similar document?

thanks in advance!
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
The FDA must accredit persons to conduct initial 510(k) reviews no later than one year after enactment. Accredited persons may not review:
- Class III devices;
- Class II devices that are permanent implants or life sustaining or life supporting; or
- Class II devices which require clinical data, except the number in this group must not be more than 6 percent of total submissions (as defined by statute).
The quoted statement does not pertain to your title question. Instead it pertains to the FDA's management of the APIP program.

The answer to your title question comes from the information page for the Product Code into which your prospective product will be classified. This page is found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm. If you enter a Product Code there...for instance, MMP...you will land at a Product Code information page that will tell you whether 510(k) applications for products in that Product Code are eligible for Third Party Review, and if so, which APIP participants are permitted to review those particular applications.
 
Thread starter Similar threads Forum Replies Date
M Medical Device News FDA - Eliminating Routine FDA news 14-09-18 - Re-Review of Third Party 510(k) Reviews Other US Medical Device Regulations 0
B 510(k) Third Party Review of Class II Medical Device US Food and Drug Administration (FDA) 13
J External third party audits Registrars and Notified Bodies 1
S Would this be a second site for the purposes of internal and third party audits? General Auditing Discussions 4
C Importer shell game - Using a third party logistics provider (3PL) in the EU EU Medical Device Regulations 5
A Looking for a third party to calibrate our measure equipment - South Carolina General Measurement Device and Calibration Topics 6
F Firmware as SOUP - Sensor with third party produced firmware IEC 62304 - Medical Device Software Life Cycle Processes 2
Marc Medical device vulnerability highlights problem of third-party code in IoT devices Other Medical Device and Orthopedic Related Topics 1
R UDI for US - Third Party device Repackager Other US Medical Device Regulations 9
S QUALITY OBJECTIVEs for third party garments factory inspection ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Looking for third party reviewers for FDA submissions US Food and Drug Administration (FDA) 2
S Regulatory strategy for Third party plugin in a PACS EU Medical Device Regulations 1
M Informational US FDA – URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Dev Medical Device and FDA Regulations and Standards News 0
G Third party auditor mentions no grace period for calibration Calibration Frequency (Interval) 22
M Informational Updated US FDA Resources for Third Party Review Organizations Medical Device and FDA Regulations and Standards News 0
Rameshwar25 Min working experience for IATF 16949 third party auditor IATF 16949 - Automotive Quality Systems Standard 5
Anerol C Becoming an IATF 16949 Third Party Auditor Career and Occupation Discussions 12
K Tips for dealing with third party auditors General Auditing Discussions 11
M AS9102 Training - Seeking third party agency that provides online AS9102 training AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A Creating a policy to evaluate the Third Party Security IEC 27001 - Information Security Management Systems (ISMS) 4
R (OOT) Measurement Equipment after the calibration at a third Party lab General Measurement Device and Calibration Topics 3
R Medical Device Cyber Security Third Party Review Other US Medical Device Regulations 6
L Medical Device Installation Records from Third Party Installer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Temporary Facility Used For Production - Use of existing Third Party Logos ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
B Third Party Service Provider Risk Rating Spreadsheet Risk Management Principles and Generic Guidelines 1
T Is Testing in a Third Party Facility Subcontracting? General Measurement Device and Calibration Topics 2
C Mexico Medical Device Third Party Reviewer Other Medical Device Regulations World-Wide 2
Q Third Party Audit Nonconformance for Training effectiveness IATF 16949 - Automotive Quality Systems Standard 20
J Eligibility for Third party review US Food and Drug Administration (FDA) 2
Mikishots AS91X0 Third Party Auditor Cycling and Changing Auditors AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
G Academic Study Investigating the Effectiveness of Third Party Audits General Auditing Discussions 2
K Third Party On-Site Servicing - Training Records Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
C Third Party Inspection and Certification Costs for a Project Registrars and Notified Bodies 7
S Incidents that occur during a Third Party Supplier Audit - Help for ISO 9001 General Auditing Discussions 23
Q Preventing Audit Finding by your third Party Registar IATF 16949 - Automotive Quality Systems Standard 5
N CE Mark and Third Party Companies Evaluation Factors CE Marking (Conformité Européene) / CB Scheme 5
E Third party auditor's statement about SPC - Steel Making - EAF Statistical Analysis Tools, Techniques and SPC 11
J Reputable Third Party Inspection (Metrology Lab) In USA? Cam Profile Measurement General Measurement Device and Calibration Topics 5
A How to Document Third-Party Audit Nonconformities related to Legislation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J AS9100 Third Party Nonconformance Closure Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
A Gamma Validation - What should a Third Party Irradiation/Gamma Company Supply EU Medical Device Regulations 2
F Integrating Third-Party Software into Software we Provide ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
H Procedure or Program and Policies for Hosting Third Party Inspections Document Control Systems, Procedures, Forms and Templates 1
T Third Party Containment in Mexico Nonconformance and Corrective Action 6
A Template for Agreements with Third Party Sorting Houses IATF 16949 - Automotive Quality Systems Standard 2
C Learning Material for a Third Party Distribution Sales Environment Training - Internal, External, Online and Distance Learning 2
1 Third Party Certifications - Certificate of Compliance for Distributors Document Control Systems, Procedures, Forms and Templates 2
O When do you say that you are ready for Third-Party Certification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 59
G Reporting QMS changes to third party auditors (certification bodies aka registrars) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
kedarg6500 Third Party Logistics & Outsourced-Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3

Similar threads

Top Bottom