CDRH's FY2027 list, published October 1, 2026, names 17 guidance topics: 13 that FDA's device center intends to publish by September 30, 2027, and 4 it intends to develop. The priority A-list includes final versions of the AI lifecycle guidance and the PCCP guidance for all devices, and a first draft on generative AI devices for mental disorders.
Key takeaways
- The list has 8 A-list items (7 final, 1 draft), 5 B-list items (3 final, 2 draft) and 4 items "under construction".
- Two long-awaited documents are A-list finals: the AI lifecycle draft of January 7, 2025, and the PCCP draft for all devices of August 22, 2024.
- Two core 510(k) topics are under construction: choosing a predicate (draft of September 7, 2023) and evaluating substantial equivalence (final of July 28, 2014).
- The list is a plan, not a promise. CDRH says it published 7 of the 11 guidances on its FY2026 list.
- You can comment until November 30, 2026, on docket FDA-2012-N-1021.
We built the tables below by checking each of the 17 items against FDA's guidance pages and the Federal Register on October 24, 2026.
What is CDRH's proposed guidance list?
It is the Center for Devices and Radiological Health (CDRH) saying which guidance documents it plans to publish in the coming fiscal year. FDA's fiscal year 2027 runs from October 1, 2026 to September 30, 2027 [10]. CDRH sorts the documents into three lists [1]:
| List | What CDRH says it means |
|---|---|
| A-list | Priority guidance documents CDRH intends to publish during FY2027 |
| B-list | Guidance documents CDRH intends to publish as resources permit |
| Under Construction | Guidance documents CDRH intends to develop as resources permit, not on the A-list or B-list |
A "final" topic means CDRH plans to publish a final guidance, usually replacing a draft. A "draft" topic means a new or revised draft for public comment. Guidance, draft or final, is not binding. It sets out FDA's current thinking on what a submission should contain, and FDA marks each draft "not for implementation".
What is on the FY2027 A-list?
Seven final guidances and one new draft [1, 2]:
| Topic | Where it stands today | Why it matters |
|---|---|---|
| AI-enabled device software functions: lifecycle management and marketing submission recommendations | Draft issued January 7, 2025 [3] | Sets what an AI device submission should contain across the product life cycle |
| Predetermined change control plans (PCCPs) for medical devices | Draft issued August 22, 2024 [4] | Extends PCCPs, already final for AI devices, to all device types |
| Quality management system information for certain premarket submission reviews | Draft from October 2025, for PMA and HDE applications [11] | Sets what quality system information FDA wants in PMA and HDE submissions under the Quality Management System Regulation (QMSR). It would replace a 2003 guidance |
| Accreditation Scheme for Conformity Assessment (ASCA) program guidances | The list does not name the documents. The likely match is three drafts issued September 23, 2024 [2] | Finals would replace the three ASCA pilot guidances of September 25, 2020. FDA says the pilot has concluded and it is establishing an ongoing program [12] |
| Robotically-assisted surgical devices: premarket submissions | Draft issued September 25, 2026, comments open until November 24, 2026 [6] | Testing, clinical data and labeling for surgical robots |
| Menstrual products: performance testing and labeling | Draft from October 2025 [2] | Testing and 510(k) content for tampons, pads and menstrual cups |
| Compliance policy for certain NIOSH-approved air-purifying respirators | Draft issued April 20, 2026 [2] | A compliance policy on premarket and other requirements for certain respirators approved by NIOSH |
| Generative AI-enabled conversational devices for mental disorders: evidentiary recommendations (new draft) | No guidance yet. FDA's Digital Health Advisory Committee met on generative AI mental health devices on November 6, 2025 [9] | Would be FDA's first guidance aimed at generative AI devices |
The robotic surgery guidance is on the A-list as a final while comments on its draft are still open [1, 6].
What is on the B-list?
Three finals and two drafts, published as resources permit [1, 2]:
| Topic | Where it stands today | What would change |
|---|---|---|
| Small business qualification and determination (final) | A final already exists, issued July 31, 2025 [7] | A revised final. FDA has not said what it would change |
| Q-Submission Program (final) | A final already exists, issued May 29, 2025 [8] | A revised final. FDA has not said what it would change |
| Pulse oximeters: performance testing, labeling and premarket submissions (final) | Draft issued January 7, 2025 [2] | Finalizes testing that accounts for skin pigmentation, replacing the 2013 guidance |
| Policy for Device Software Functions (draft) | Current final from September 28, 2022, titled "...and Mobile Medical Applications" [2] | A revised draft. The new title drops "Mobile Medical Applications" |
| Postmarket management of cybersecurity (draft) | Current final from December 28, 2016 [2] | A revised draft of the nearly 10-year-old postmarket guidance |
What is under construction?
Four topics CDRH intends to develop as resources permit [1, 2]:
| Topic | Where it stands today |
|---|---|
| Considerations for selecting a predicate device for a 510(k) | Draft titled "Best Practices for Selecting a Predicate Device", issued September 7, 2023 |
| Evaluation of thermal effects of devices that heat or cool tissue | Draft issued March 15, 2024 |
| Risk assessment and evidence for generative AI-enabled devices | No guidance. FDA published a discussion paper on August 18, 2026, which it says is not draft or final guidance [9] |
| Select updates for the 510(k) program: evaluating substantial equivalence | Current final from July 28, 2014 |
The two 510(k) items touch every submitter. How FDA judges predicates and substantial equivalence is the core of the 510(k). But Under Construction is the lowest tier: CDRH intends to develop these topics as resources permit, and the list gives no date [1].
What does the list mean for AI device makers?
The direction is clear: more AI guidance moves from draft to final. Five items concern AI or software directly, and a sixth, PCCPs for all devices, matters to every AI device maker [1]:
- AI lifecycle guidance (A-list final). The January 7, 2025 draft covers what goes into an AI device submission, such as the model description, data management and performance validation [3]. A final version would replace the draft as FDA's current thinking.
- PCCPs for all devices (A-list final). The PCCP guidance for AI devices is already final, issued December 4, 2024 and updated August 18, 2025 [5]. The all-device draft uses the same three-part plan for any device type [4]. Our guide to FDA's PCCP examples for continuously learning AI shows what a plan looks like.
- Generative AI for mental disorders (A-list draft). A new draft on the evidence FDA expects for conversational devices for mental disorders [1].
- Generative AI risk assessment (Under Construction). A topic on risk assessment and evidence for generative AI devices in general. FDA's August 2026 discussion paper on regulating generative AI devices asks for public feedback, but it is not guidance [1, 9].
- Software policy (B-list draft). A revision of the policy that explains which software functions FDA oversees as devices and where it does not intend to enforce requirements [2].
- Postmarket cybersecurity (B-list draft). A revision of the December 28, 2016 final on managing cybersecurity in devices already on the market [2].
Draft guidance is not binding, so you are not required to follow it. But a draft shows where FDA's review is heading. If you are building an AI device now, designing your evidence to the January 2025 draft can reduce the risk of rework when the final arrives.
Knowing which guidance applies to your own device is the hard part. Complizen's Knowledge identifies the guidance documents that apply to your device and pulls the passages relevant to each submission section.
What does the list mean for 510(k) submitters?
Three groups of items matter most to 510(k) submitters [1, 2]:
- ASCA. Final ASCA guidances would replace the three 2020 pilot guidances for the accredited test lab program [12]. Our guide to using test reports from non-US labs explains when an ASCA summary test report may stand in for a full test report. It counts 98 ASCA-accredited labs as of October 12, 2026, 42 of them outside the US.
- Q-Submission and small business. Both already have recent finals. FDA has not said what a revision would change [7, 8].
- Predicates and substantial equivalence. Both are under construction, and neither is scheduled for FY2027. The September 2023 predicate draft remains FDA's latest thinking on choosing a predicate [2].
The quality system item on the A-list is for PMA and HDE applications, not 510(k)s [11]. The QMSR itself, FDA's amended 21 CFR part 820, took effect on February 2, 2026 [11].
How reliable is the list?
Fairly, but not fully. CDRH says it published 7 of the 11 guidances on its FY2026 list, 5 from the A-list and 2 from the B-list [1].
Drafts take time to finalize. CDRH has committed to act on 80% of draft guidances within 3 years of the comment period closing, and on 100% within 5 years, as resources permit [1]. Acting means finalizing, withdrawing, reopening comment on, or reissuing the draft. Its own record:
| Drafts issued in | Action within 3 years | Action within 5 years |
|---|---|---|
| FY2016 | 23 of 29 (79%) | 25 of 29 (86%) |
| FY2018 | 22 of 24 (92%) | 23 of 24 (96%) |
| FY2019 | 23 of 25 (92%) | 24 of 25 (96%) |
| FY2020 | 9 of 10 (90%) | 10 of 10 (100%) |
| FY2021 | 9 of 9 (100%) | 9 of 9 (100%) |
| FY2022 | 15 of 15 (100%) | 15 of 15 (100%) |
Source: CDRH Proposed Guidances for FY2027 page [1]. CDRH also reports 6 of 6 for FY2017, and 2 drafts issued before October 1, 2020 still without action [1].
For planning, treat an A-list final as an FDA priority for the year, not a date. Treat anything Under Construction as a signal of direction only.
How do you comment on the list?
CDRH accepts comments until November 30, 2026 [1]. The steps:
- Go to the docket. Open docket FDA-2012-N-1021 on regulations.gov [1].
- Pick your topic. CDRH seeks comments especially on the relative priority of A-list and B-list items, and on policy or information to include in them.
- Suggest new guidance if needed. CDRH welcomes suggestions for new or different guidance documents, with the reasons a guidance on the topic is needed.
- Give reasons for any revision or withdrawal. If you recommend changing or withdrawing an existing guidance, CDRH requests that commenters also include why, and, if applicable, how it should be revised.
- Mark confidential material. Comments are publicly viewable unless submitted as "Confidential Submissions".
You can also email the CDRH Guidance Program at any time [1].
What should manufacturers outside the US do now?
Use the list to plan your next 12 months, especially in three areas:
- Testing. If your test lab is outside the US, check whether it is ASCA-accredited for the standards you need. Final ASCA guidances would set the rules for the ongoing program [12].
- AI devices. If you plan a submission in 2027, build to the January 2025 AI draft and consider a PCCP for future model updates. FDA "encourages manufacturers to leverage the Q-Submission Program" for feedback on a proposed PCCP, but it does not authorize a PCCP in a Pre-Submission [4, 5]. Our Q-Submission hub explains how a Pre-Submission works [8].
- Fees. The small business final of July 31, 2025 reflects FDA's planned replacement of Forms 3602 and 3602A with one combined form, Form FDA 3602N. FDA's small business page now lists Form 3602N as part of a complete request [7]. Our guide to FDA small business designation walks through it. From October 1, 2026, a 510(k) costs $28,653, or $7,163 for a small business [10].
If a guidance change could affect a submission you are already preparing, Complizen's free gap assessment checks your device documents against what FDA expects today.
Frequently asked questions
What is the CDRH A-list?
The A-list names the guidance documents CDRH intends to publish as priorities in the coming fiscal year. For FY2027, it has eight items: seven final guidances, including AI lifecycle and PCCPs for all devices, and one new draft on generative AI devices for mental disorders.
What is the difference between the A-list and the B-list?
CDRH intends to publish A-list guidances during the fiscal year. It intends to publish B-list guidances only as resources permit. For FY2027, the B-list holds five items, including revised finals for the Q-Submission Program and small business qualification, and a pulse oximeter final.
When will FDA finalize the AI-enabled device guidance?
FDA has not given a date. The final AI lifecycle guidance is on CDRH's FY2027 A-list, which covers October 1, 2026 to September 30, 2027. The current version is the draft of January 7, 2025. A-list placement means it is a priority, not that publication is guaranteed.
Is the PCCP guidance for all devices final yet?
No. The PCCP guidance for all medical devices is still a draft, issued August 22, 2024. CDRH lists a final version on its FY2027 A-list. The separate PCCP guidance for AI-enabled devices is already final, issued December 4, 2024 and updated August 18, 2025.
Will FDA issue guidance on generative AI devices?
FDA intends to. The FY2027 A-list includes a new draft on generative AI conversational devices for mental disorders. The Under Construction list adds risk assessment for generative AI devices in general. FDA's August 18, 2026 discussion paper on generative AI is not guidance.
What is the deadline to comment on CDRH's FY2027 list?
November 30, 2026. Submit comments on regulations.gov under docket FDA-2012-N-1021. CDRH asks especially about the priority of A-list and B-list items. It also welcomes suggestions for new guidance, and asks that any request to revise or withdraw a guidance explain why.
Does a draft guidance apply to my submission?
Not as a requirement. Guidance, draft or final, is not binding, and FDA marks drafts "not for implementation". But a draft shows FDA's direction, and reviewers may raise the same points. Building to an important draft, such as the January 2025 AI draft, can reduce the risk of rework.
How many guidances on last year's list did CDRH publish?
CDRH says it published 7 of the 11 guidances on its FY2026 list: 5 from the A-list and 2 from the B-list. So the list is a reliable signal of direction, but not every item appears within the year. Plan around A-list items, not Under Construction ones.
Is FDA changing the predicate device guidance?
Possibly, but not soon. "Considerations for Selecting a Predicate Device" is on the FY2027 Under Construction list. The current document is a draft titled "Best Practices for Selecting a Predicate Device", issued September 7, 2023. Under Construction items are published only as resources permit.
What is ASCA, and why does it matter?
ASCA is FDA's Accreditation Scheme for Conformity Assessment, for test labs accredited to certain FDA-recognized standards. FDA says the pilot has concluded. Final ASCA program guidances are on the FY2027 A-list and would replace the three pilot guidances issued September 25, 2020.
Is FDA updating the mobile medical apps policy?
It plans to, as resources permit. The B-list includes a revised draft "Policy for Device Software Functions". The current final, from September 28, 2022, is titled "Policy for Device Software Functions and Mobile Medical Applications". The new title drops the mobile apps wording. FDA has not published the revision yet.
Will the Q-Submission guidance change again?
Possibly. A revised final Q-Submission guidance is on the FY2027 B-list, even though the current final was issued May 29, 2025. FDA has not said what it would change. Until then, the May 2025 version, with its 70-day feedback goal, applies.
References
- FDA. CDRH Proposed Guidances for Fiscal Year 2027 (FY 2027), with the A-list, B-list and Under Construction list (PDF) and docket FDA-2012-N-1021 on regulations.gov. Content current as of October 1, 2026. Comments due November 30, 2026.
- FDA. Search for FDA Guidance Documents, guidance pages and cover pages for each listed topic, with notices of availability in the Federal Register. Checked October 24, 2026.
- FDA. Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations. Draft guidance, January 7, 2025.
- FDA. Predetermined Change Control Plans for Medical Devices. Draft guidance, August 22, 2024.
- FDA. Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions. Final guidance, issued December 4, 2024, updated August 18, 2025.
- FDA. Robotically-Assisted Surgical Devices: Premarket Submissions. Draft guidance, September 25, 2026.
- FDA. Medical Device User Fee Small Business Qualification and Determination. Final guidance, July 31, 2025. And FDA, Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program. Checked October 24, 2026.
- FDA. Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. Final guidance, May 29, 2025.
- FDA. Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback. August 18, 2026. And FDA, November 6, 2025: Digital Health Advisory Committee Meeting Announcement.
- FDA. Medical Device User Fee Rates for Fiscal Year 2027. Federal Register, July 30, 2026.
- FDA. Quality Management System Information for Certain Premarket Submission Reviews (PDF). Draft guidance, October 2025, for PMA and HDE applications.
- FDA. Accreditation Scheme for Conformity Assessment (ASCA) Annual Report, Calendar Year 2025 (PDF).