Who Is Required To Submit A 510(K)?
The obligation to file a 510(k) is not explicitly outlined in the FD&C Act or the 510(k) regulation (21 CFR 807). Instead, specific actions, such as introducing a device to the American market, trigger the requirement for a 510(k) submission. The regulatory framework specifies situations in which manufacturers must initiate the 510(k) process, emphasizing a proactive approach to ensure compliance and the safety of medical devices available to the public. This regulatory mechanism encourages manufacturers to thoroughly assess their devices and seek clearance before market entry, contributing to a robust system of checks and balances in the medical device approval process.
Four groups of individuals or organizations must submit a 510(k) to the FDA
- Domestic manufacturers introducing a device to the U.S. market
- Specification developers introducing a device to the U.S. market
- Repackers or relabelers who make labeling changes or whose operations significantly affect the device
- Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market
Domestic
manufacturers introducing a device to the U.S. market
Specification
developers launching a device in the U.S. market
Re-packers or re-labellers
affecting the device through labelling changes or significant operations
Foreign
manufacturers/exporters or U.S. representatives of foreign
manufacturers/exporters introducing a device to the U.S. market
When a 510(k) is required?
A 510(k) is required when:
- Unless excluded, the initial release of a gadget into commercial distribution (marketing). Even though a device may have been in development or under clinical investigation prior to May 28, 1976 (the effective date of the Medical Device Amendments to the Act), anyone who wants to sell a device in the United States must submit a 510(k) application at least 90 days before offering the device for sale. A 510(k) is necessary if your company did not commercialize your product before May 28, 1976.
- A legally marketed device has undergone a change or modification that may have a major impact on its effectiveness or safety. The onus is on the 510(k) holder to determine whether or not a modification would materially impair the device's effectiveness or safety. The Device Master Record and Change Control Records must be updated with any modifications in line with the Quality System Regulation, 21 CFR 820. It is advised that the change control records include the justification for submitting or not submitting a new 510(k).
- If a current device is changed or modified in a way that could significantly impact its effectiveness or safety, or if the device is being marketed for a new or different intended purpose, a new 510(k) submission is necessary.
When a 510(k) is not required?
The following are examples of when a 510(k) is not required;
- You either sell unfinished products to another company for additional processing or sell parts for other companies to assemble gadgets from. A 510(k) is necessary, nevertheless, if your parts are going to be sold directly to consumers as replacements.
- Your device is not being advertised or sold commercially. To create, access, or test a device, you don't require a 510(k). This also covers clinical assessment. Please be aware that the Investigational Device Exemption (IDE) legislation applies if you use your device in clinical trials (21 CFR 812).
- You distribute a product made in the United States by another company. You can sell a device to end users without submitting a 510(k) by labeling it "Distributed by ABC Firm" or "Manufactured for ABC Firm" (21 CFR 801.1).
- Repackaging or relabeling is generally acceptable as long as the device's condition or labeling is not materially altered. The labeling should have the same warnings, precautions, and indications for use as the labeling submitted in 510(k).
- Your device's design, components, manufacturing process, or intended purpose have not been materially altered since it was first legally distributed commercially on May 28, 1976. You have documentation demonstrating your Preamendment Status that shows these devices are "grandfathered."
- You are the importer of the medical equipment made outside of the United States. If a 510(k) has been submitted by the foreign manufacturer and acquired marketing clearance, it is not necessary to submit another one. The foreign manufacturer may export his product to any U.S. importer after receiving 510(k) authorization for the device.
- The regulation exempts your product from the 510(k) rule (21 CFR 862-892). In other words, some Class I or II devices can be marketed for the first time without a 510(k) submission (k). On the pages Medical Device Exemptions 510(k) and GMP Requirements, you may find a list of Class I and II exempted devices. However, if the device goes beyond the restrictions of the exemptions in Chapter.9 of the Device Classification Regulations (e.g., 21 CFR 862.9, 21 CFR 864.9), or if it is a reprocessed single-use device, or if it has a different intended use or uses a different fundamental scientific technology than a legally marketed device in that generic type of device, then a 510(k) must be submitted in order to put the new device on the market.
510(K) SUBMISSION PROCESS
1 Acknowledgement of Receipt
You
can send an eSTAR or eCopy to submit
your 510(k).
The FDA will give your 510(k) submission a special control number once it
has been submitted to them and has been received by them. The "510(k)
number" or "K number" is the name given to this number. The
510(k) number has a letter "K" at the start, then 6 digits. The last
four digits represent the submission number for the year, which starts with
0001 and rises with each subsequent submission. The first two digits indicate
the calendar year in which the submission was received.
For example: The
first 510(k) submission for calendar year 2022 is K220001.
The FDA then conducts two verification checks to confirm that:
a)
The proper user fee payment was received for the submission.
Note: the user fee amount to be paid is based on when the 510(k) is
received by the FDA and not the date on which it was sent by the submitter.
b)
A valid eSTAR or eCopy of the 510(k) submission was provided.
The FDA will email a hold letter to the 510(k) submitter if the correct
user fee, a valid eSTAR, or an eCopy are not submitted, typically within seven
days of receiving the 510(k) (k). Following receipt of the Hold Letter, the
submitter has 180 calendar days to completely address any problems with the
user fee or submission. The 510(k) is deemed to be withdrawn and deleted from
our review system if the concerns are not corrected within 180 days. The
submitter will then need to submit a new, complete 510(k) in order to request
FDA marketing clearance.
The FDA will email an Acknowledgment Letter to the contact person listed
in the 510(k) submission if the correct user fee has been paid AND a valid
eSTAR or eCopy has been submitted. According to the Acknowledgement Letter,
identifies:
Ø The date of receipt (this is the date that FDA received the 510(k)
submission, the proper user fee payment, and valid eSTAR or eCopy); and
The 510(k) number assigned to the submission.2 Format and Submission
Acceptance Review
eSTAR
It is not envisaged that eSTAR submissions would go through a refuse to
accept (RTA) process because an electronic submission that has been properly
prepared using an electronic submission template should be a full submission.
For an eSTAR, however, FDA plans to use a virus scanning and technical
screening method.
The 510(k) will be placed on hold until a complete replacement eSTAR is
submitted to the FDA if the FDA receives an incomplete eSTAR submission. The
FDA will email the submitter to alert them of the incomplete information. The
FDA will consider the 510(k) to be withdrawn and the submission will be closed
in the system if a new eSTAR is not received within 180 days of the date of the
technical screening deficiency notification.
For eCopy
The
Lead Reviewer conducts the Acceptance Review using the appropriate Acceptance Checklist in FDA's Guidance titled Refuse to Accept Policy for
510(k)s.
Based
on the device type and medical specialization stated in the 510(k) submission,
the FDA sends the 510(k) to the relevant OHT after sending the Acknowledgement
Letter.
The
Lead Reviewer decides whether the 510(k) submission satisfies the minimal
standard of acceptability and should be accepted for substantive review during
the acceptance review.
The
submitter will get an electronic notification of the Acceptance Review outcome
within 15 days of the submission's receipt, which will:
Ø Identify the name and
contact information of the FDA Lead Reviewer assigned to the 510(k);
Ø Indicate the status of
the 510(k).
The Acceptance Review result
will be one of the following:
Ø The 510(k) was accepted
for substantive review; or
Ø The 510(k) was not
accepted for review (i.e., considered refused to accept or RTA); or
Ø The 510(k) is under
substantive review because FDA did not complete the acceptance review within 15
calendar days.
510(k)s
that are rejected for review are put on RTA Hold. The submitter has a total of
180 calendar days to completely fix the issues listed in the RTA Hold. The
510(k) is regarded as withdrawn and removed from our review system if this is
not done. A new, complete 510(k) must be submitted by the 510(k) submitter in
order to request FDA marketing clearance for the device if the original 510(k)
is deleted.
Once accepted, a 510(k) proceeds to the Substantive
Review.
3 Substantive Review
(including Substantive Interaction and Interactive Review)
The Lead Reviewer performs a thorough examination of the 510(k) submission during substantive review. The Lead Reviewer also interacts with the submitter during substantive review, which must take place within 60 days of the submission's receipt.
The Substantive Interaction communication is typically:
Ø An email stating that
FDA will proceed to resolve any outstanding deficiencies via Interactive Review;
or
Ø An Additional
Information (AI) request which places the submission on hold.
Interactive Review
The submission won't be
put on hold if the Lead Reviewer decides to move on with an Interactive Review
and finds that any unresolved issues can be appropriately addressed within the
Medical Device User Fee Amendment (MDUFA) period. During the Interactive
Review, the Lead Reviewer communicates with the Submitter utilizing
technologies like:
Ø Email
Ø Telephone Call
The submitter may
transmit additional information to the Lead Reviewer directly or to the FDA in
response to a request made by the Lead Reviewer during Interactive Review. The
FDA must receive a valid eSTAR or eCopy with every piece of information given
to them during Interactive Review.
5 Additional Information (AI) Request
Submissions are put on hold if the Lead Reviewer submits an AI Request. A full answer to the AI Request must be sent by the submitter within 180 days after the AI Request's date.
Note: The FDA must receive a complete response within 180
calendar days of the date of the AI Request. No extensions beyond 180 days are
granted
The
application will be deemed withdrawn and removed from our review system if FDA
does not receive a thorough response to all faults in the AI Request within 180
days of the AI Request's date. The 510(k) submitter will need to file a new
510(k) in order to get FDA marketing clearance if the original 510(k) is
removed.
The FDA
must receive the response from the submitter together with an authorised eSTAR
or eCopy. Included in the answer should be:
Ø Submitter's name;
Ø 510(k) number;
Ø Identification of the
submission as Additional Information (AI) to the 510(k);
Ø Date of the FDA's
request for additional information; and
Ø The requested information in an organized manner
6 510(k) Decision Letter
The FDA has a 90-day deadline for making a 510(k) decision under the MDUFA. The number of calendar days, excluding the days the submission was put on hold due to an AI request, that passed between the date the 510(k) was received and the date of an MDUFA decision is known as the "FDA Days." Findings of substantially equivalent (SE) or not substantially equivalent are included in MDUFA Decisions for 510(k) submissions (NSE).
The FDA
will send the determination letter to the submitter via email at the address
specified in the 510(k) cover letter after a decision has been made.
A 510(k)
is deemed "cleared" if it receives a SE decision. Each week, the FDA
updates the 510(k) database with newly cleared 510(k)s. The 510(k) Summary or
510(k) Statement and the Indications for Use (IFU) will be attached to the SE
letter. A SE package is made up of the IFU and the 510(k) Summary or Statement.
Each month, complete SE packages are posted. Since the IFU is seen as an
attachment to the SE letter, it will not be signed. As a result, the SE
letter's signature will be valid for both the letter and the IFU.
The FDA
will issue a Missed MDUFA Communication, which is written feedback to the
submitter to be discussed in a meeting or teleconference, including the major
outstanding review topic areas or other reasons that are preventing the FDA
from reaching a final decision, with an estimated date of completion, if the
FDA does not reach an MDUFA decision within 100 FDA days (that is, 10 days
after the MDUFA goal).
In order
to determine substantial equivalence, the FDA adopts a decision-making
procedure that includes several key judgment factors.
510(K) SUBMISSION PROGRAM
1
Traditional 510(k)
The Traditional 510(k) may be used for any original
510(k) or for a change to a previously cleared device under 510(k).
The FDA generally reviews Traditional 510(k) submissions within 90 days of receipt. It is always possible to request marketing authorization for a device through the 510(k) Program by using the Traditional 510(k) Program.
2
Special 510(k)
If the method(s) to analyze the change(s) are
well-established and the results can be appropriately examined in a summary or
risk analysis format, device manufacturers may opt to submit a Special 510(k)
for adjustments to their own current device. For devices that produce biological
products at the point of care, a Special 510(k) would typically not be
appropriate because there would not be a well-established way to assess such
changes and/or the performance data would not be reviewable in a summary or
risk analysis format.
As identified in the guidance The Special 510(k) Program, design or labeling change(s) to an existing
device (including certain changes to the indications for use) may be
appropriate for a Special 510(k) when:
Ø The manufacturer who has the legal right to
market the current device has proposed the change;
Ø Performance data are not required, or if
they are, well-established methods are available to assess the change;
Ø And all performance data required to
support substantial equivalence can be reviewed in a summary or risk analysis
format.
3
Abbreviated 510(k)
Device manufacturers may choose to submit an Abbreviated
510(k) when the submission relies on:
Ø
FDA
guidance document(s),
Ø Demonstration of compliance with
special control(s) for the device type, or
Ø Voluntary consensus standard(s).
The required components listed in 21 CFR 807.87
[Traditional 510(k)] must be included in an abbreviated 510(k) submission. To
aid in the review of a submission, businesses choose to include brief reports
on the usage of guidance papers, special controls, or declarations of
compliance with FDA regulations in an Abbreviated 510(k) submission. When submitting
an Abbreviated 510(k), manufacturers who rely on widespread adoption of a
voluntary consensus standard must provide the rationale for this adoption as
well as any supporting evidence or data.
HOW TO SUBMIT A 510(K)
A 510(k) submission must be submitted as an eSTAR or eCopy.
Online:
Send eSTAR or eCopy premarket
submissions online through the CDRH Customer Collaboration Portal (CDRH Portal)
By Mail:
The FDA only intends to accept 510(k) submissions saved to a
form of electronic storage media and mailed to the FDA if they are received by
the FDA before October 1, of every year.
Mail your submission to the current mailing address for
CDRH's DCC and a link to CBER's DCC's mailing address are provided on the eCopy Program for Medical Device Submissions webpage.
We advise you to use registered mail with a return
receipt or a commercial delivery service to transmit your 510(k) to the FDA so
that a signed receipt of delivery will be provided.
The FDA should send you an acknowledgment of receipt with
the allocated 510(k) number.
After the FDA receives the submission, the review procedure is described on the 510(k) Submission Process webpage.