New FDA Draft Guidance on 510(k) Ownership and Use

M

MIREGMGR

#1
FDA published a new Draft Guidance today:

Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers

Much of this guidance simply repeats the several-year-existing direction that the party responsible for marketing of a device must List it using the FURLS online system, and must be the party responsible for the relevant 510(k) for the device if one is required.

The guidance however also includes this statement that to my understanding represents an extension of prior rules. I quote the first sentence only to provide context for the second sentence, which is important and I have bolded:

Because contract manufacturers and sterilizers, foreign exporters, and foreign private label distributors are not responsible for the commercial distribution of devices, they would not be 510(k) holders, and should list the product under their customer’s 510(k) number once it has been listed by the 510(k) holder. Any entity that fails to list as required renders the device misbranded.
A requirement that contract processors must List has existed for several years. FDA however has not previously connected that second- or third-party behavior to the legal device status of the device owner.

This in my view is particularly interesting in regard to offshore contract sterilizers working for offshore contract manufacturers, who are third parties to the device owner and therefore one step removed from the device owner's direct control. Such control of course always has been required for sterilization validation, process-performance verification and certain logistics operations related to not mixing up non-sterile and sterile devices. Until now, though, the second- and third-party Listing requirement has been regarded by the industry, I think, as one that would get the second or third party in trouble...not the device owner.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
I wonder how it settles with the FD&C act and with the regulations. After all, it is a guidance. I'm sure that as far as the FDA is concerned "guidance" reflects what they expect to see, I just wonder whether that approach is legally enforceable (i.e. would hold in a court appeal etc.). Were the legal instruments amended in any way?
 

Ajit Basrur

Staff member
Admin
#3
For the Contract Manufacturer, when the device is listed in FURLS, it is required to link to the customer's product details like 510(K) and Product Code.
 
M

MIREGMGR

#4
I wonder how it settles with the FD&C act and with the regulations. After all, it is a guidance. I'm sure that as far as the FDA is concerned "guidance" reflects what they expect to see, I just wonder whether that approach is legally enforceable (i.e. would hold in a court appeal etc.). Were the legal instruments amended in any way?
In USA, the relevant laws have long been interpreted by high level courts to provide FDA and other executive-branch agencies the latitude to define rules as needed for implementation of the laws for which that agency is responsible. The powers of executive agencies are a much broader area of law than just FDA, and are well settled at the constitutional level. FDA's Guidances in general have this legally-acknowledged-rule status once finalized, depending on the specific language used in the Guidance.

In any case, in practice, FDA rarely if ever directly cites for failure to implement a Guidance...for instance, in a Warning Letter or a request for injunction. Instead they cite for "misbranding" or one of the other broadly defined violations in the FDC Act.
 
Thread starter Similar threads Forum Replies Date
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Clinical Decision Support Software Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Patient Engagement in Design and Conduct of Medical Device Clinical Investigations Medical Device and FDA Regulations and Standards News 0
M Informational FDA draft guidance – Safer Technologies Program for Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational US FDA draft guidance – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Medical Device and FDA Regulations and Standards News 0
M Informational US FDA draft guidance. – Clinical Investigations for Prostate Tissue Ablation Devices Medical Device and FDA Regulations and Standards News 2
M Informational US FDA draft guidance – Mouse Embryo Assay for Assisted Reproduction Technology Devices Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – Nonbinding Feedback After Certain FDA Inspections of Device Establishments Medical Device and FDA Regulations and Standards News 0
Ronen E FDA releases new draft guidance on when to submit a 510(k) for device modification Other US Medical Device Regulations 10
Ronen E FDA issues draft guidance on form & content of UDI Other US Medical Device Regulations 0
Ronen E FDA issues draft guidance on additive manufacturing Other US Medical Device Regulations 1
R New Draft Guidance Document for FDA's current thinking on De Novo submission Other US Medical Device Regulations 1
S FDA Draft Guidance on HLA Kits 510(k) Submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Y New Draft FDA Guidance for Applicability of GLP in Medical Device Submission Other US Medical Device Regulations 2
M FDA issues draft guidance to replace G95-1 (Application of ISO 10993) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S New Draft FDA Guidance to distinguish b/w Recall and Product Enhancement & Reporting Other US Medical Device Regulations 15
bio_subbu US FDA issues Draft Guidance on Premarket Approval (PMA) Acceptability Other US Medical Device Regulations 0
Ronen E New FDA Draft Guidance on Enteral Connectors Misconnection considerations Other US Medical Device Regulations 0
Ronen E FDA publishes Draft Guidance on Med Dev Pre-Submission Program and Meetings with FDA Other US Medical Device Regulations 0
Ronen E FDA distributes draft guidance related to X-ray Imaging Device 510(k)s Other US Medical Device Regulations 1
Ajit Basrur FDA issues draft guidance on nanotechnology US Food and Drug Administration (FDA) 1
bio_subbu FDA releases draft guidance on Providing Regulatory Submissions in Electronic Format Other US Medical Device Regulations 1
bio_subbu FDA issues draft PMA (Pre-Market Approval) Clinical Study Guidance 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
sagai New Draft Guidance from FDA - Factors considered for Risk/Benefit Determination Other US Medical Device Regulations 4
S FDA Draft Guidance on Mobile Medical Applications US Food and Drug Administration (FDA) 1
bio_subbu FDA issues first draft guidance document on Mobile Medical Applications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
S New draft FDA Classification Guidance US Food and Drug Administration (FDA) 1
S New Draft FDA Guidance - Human Factors & Usability Engineering for Med Device Design US Food and Drug Administration (FDA) 0
S New Draft FDA Guidance on Enforcement of INDs - Safety Reporting Requirements US Food and Drug Administration (FDA) 0
S New US FDA Draft Guidance on Final Disclosure by Clinical Investigators US Food and Drug Administration (FDA) 0
Y Draft FDA Guidance on "Presenting Risk Information in Prescription Drug and Device" US Food and Drug Administration (FDA) 1
Ajit Basrur FDA releases new Draft Guidance - Process Validation - Gen Principles and Practices Qualification and Validation (including 21 CFR Part 11) 27
D Upcoming FDA ISO 13485 audit guidance (draft version) ISO 13485:2016 - Medical Device Quality Management Systems 19
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Medical Device and FDA Regulations and Standards News 0
M Informational Several US FDA draft guidances, including some specific device guidances for the Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 0
P Understanding FDA draft "Management of Cybersecurity in Medical Devices" Medical Information Technology, Medical Software and Health Informatics 3
M Medical Device News FDA Releases Draft Recommendations on Premarket Submissions for Management of Cybersecurity in Medical Devices Other US Medical Device Regulations 0
M Medical Device News FDA news - 05-09-18 - Draft - Uncertainty in Benefit-Risk Determinations Other US Medical Device Regulations 0
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
T Definition Human Use (FDA) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
K FDA 510k electrosurgery 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J Leveraging FDA 510k Clearance for International Registrations Other Medical Device Regulations World-Wide 2
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 0
J FDA notification of address change US Food and Drug Administration (FDA) 2
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 3
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
Edward Reesor FDA DM and /or Class I Life Saving US Food and Drug Administration (FDA) 0

Similar threads

Top Bottom