GxPlex

FDA device cybersecurity (2026)

Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions

Recorded status
final (basis: person-ratified)
Last person check
— a person confirmed the status this entry publishes
Last observation
Retained text
held — Prose was extracted from the retrieved bytes, so a quotation from this document can be checked against what this record retained.

3 corrections name this row · last → history

Evidence coverage#

Of the 12 rungs of this entry’s evidence ladder: 8 held · 0 held in part · 2 read, and not there · 2 nothing held.

The 12 rungs, each with its mark
  1. identity — held
  2. publisher — held
  3. jurisdiction — held
  4. type — read, and not there
  5. current edition — held
  6. publication date — nothing held
  7. lifecycle signal — nothing held
  8. publisher notices — read, and not there
  9. observation history — held
  10. text — held
  11. diff — held
  12. verification — held

A rung marked nothing held has no recorded reading; one marked read, and not there has a reading that ran and did not find it. Rungs stand in the ladder’s fixed order and the counts in this fixed order of marks: held · held in part · read, and not there · nothing held; neither order says anything about this entry. The counts on /coverage are counted by rules of their own, so a rung here and a count there of one name can differ. The sentence behind each mark is in the evidence ladder, under Evidence.

What this record does not establish#

No conclusion is drawn from absence. An absence here is not evidence that a document does not exist, is not in force, or does not govern.

Of the 12 rungs on this entry, 8 are held, 0 are held in part, and 4 cannot be established from what this record holds. Each of those carries the reading that produced it and whose blank it is. Ordered by whose blank each names: this record’s own first, then the publisher’s, then the blanks this record cannot attribute at all.

  1. type the publisher’s own surface the class the document calls itself, quoted from its own title The title was read and it does not call this document a regulation, a guidance or a standard, so no class is recorded.
  2. publication date this record has not looked a date the publisher states for this document No reading of a publication date is recorded for this entry.
  3. lifecycle signal this record has not looked a stage, step or status wording read from a publisher surface No read of a publisher surface for a stage or status wording is recorded for this entry.
  4. publisher notices this record cannot tell which official notices the publisher issued about this document A collection of publisher notices has succeeded and none of the records it holds attaches to this entry.

2 this record has not looked — no reading of this rung is recorded here. The blank is this record’s, and it is not evidence about the publisher · 1 the publisher’s own surface — a reading reached a surface the publisher published and what was asked for is not on it, bounded to the surfaces read · 1 this record cannot tell which — what is held does not say whether the blank is the publisher’s or this record’s. This is an absence of an attribution, not a kind of one

Established for this entry: identity · publisher · jurisdiction · current edition · observation history · text · diff · verification. Held in part: none of them.

The reading behind every one of those is stated rung by rung in the evidence ladder under Evidence, and the public evidence each was marked from is published in full on this page under Timeline, Publisher neighbourhood, Observation history and Sources.

What this record undertakes for this entry is stated in 6 terms, each answering one question, and each answered for this entry in the coverage contract under Evidence:

  1. Observed cadence: how often this record has reached this entry’s address
  2. Text: public, and retained: whether the publisher’s text is public, and whether prose from it is kept here
  3. Hash: what is digested for this entry, and of what
  4. Status verification: which check this record undertakes for the published status, and which it holds
  5. Lifecycle tracked: which lifecycle facts this record follows for this entry
  6. Known limits: the limits this entry’s own record declares

Overview#

Open primary source (opens in new tab) fda.gov View observation 2026-11-02 · sequence 1

Document status what the publisher asserts, and the status recorded here

Publisher lifecycle field: none captured

No status read is recorded for this entry — this record has not read a publisher surface for its status, which is a fact about this record and not about the publisher. A status read is recorded for 7 of 132 tracked entries, 5 of which banked a passage.

Recorded status: final (basis: the act named under Established by)

Verification what a person or a tool has confirmed here, and when

Publisher: US Food and Drug Administration Last checked: Last read:

Evidence state what this record holds

verified by a person — a person checked this entry against the primary source on a recorded day

How this status is recorded
Recorded
final — no as-of date is recorded
Established by
A person confirmed this entry on 8 August 2026.
Evidence
In Current status on this page.
Published at
This record names no separate surface for the status. The primary source it holds is the primary source (opens in new tab). This entry's record is published in machine form at /api/v1/instruments.json.

Filed core. For that label this archive undertakes to close an entry's open status question by rule on a clock, with its reason, and to re-read a ratification on record against its observation every night. The label records what this archive undertakes for a class of entries. It states no finding about this one, and it is not a ranking.

Resolution: direct document

What this archive can and cannot establish about this entry. The document was content-confirmed on 2026-08-08 — page 1 of the PDF FDA links from its own guidance index carries this title — the served page carries this title and FDA's own statement that it supersedes the June 2025 edition. The status was confirmed by a person on 2026-08-08 and published as `final`: the verification log holds this row's only status event, unknown to final, actor human, and the evidence record `fda-device-cybersecurity-2026--status--2026-08-08` carries `confirmed_by: human`, read from FDA's structured guidance index. Corrected 2026-08-25: this account previously ended by saying no status had been confirmed by a keypress and the value stayed unknown. It was written before that confirmation and was left in place after it, so a published `final` and an account denying it rendered together on this page until today.

Authority
US Food and Drug Administration
Jurisdiction
US
Status
final
Effective date
— this record holds no effective date for this entry
Last changed
—
Last verified
(person-ratified: a key stands on the status this entry publishes)
Watch cadence
monthly
Crawlable
unknown
Text licence
freely reproducible
Primary source
Primary source (opens in new tab) fda.gov
Listed at
discovery route (opens in new tab) fda.gov
Topics
cybersecurity

Timeline#

The dated facts this record holds for this entry. Each line below states what one kind of dated fact amounts to here, and links to the list holding it where this entry has one; the list carries the dates, the words and the addresses they were read from. Nothing is counted twice: where a line states a number, the section it names states none.

What is not published. This build serves 3 address(es) holding a time-ordered list for an entry — a TimeMap in JSON, its link-format sibling and an index — each expanding to one document per tracked entry. What they list is CAPTURES of this entry’s source held at a web archive, carrying that archive’s own capture instants; this record serves no copy of a tracked document, so none of those addresses is one of this record’s, and a capture address is published only where the terms filing recorded for the source host permits it. This entry’s own is at /api/v1/timemap/fda-device-cybersecurity-2026.json. The route set naming them, and what each one answers, is published at /developers.

Change history#

Publisher neighbourhood#

What sits around this entry, counted. Every figure below is drawn from a value already rendered elsewhere on this page; where a count has a list, the count is here and the list stays in the section holding its evidence.

The direct document, and the activity around it what this record’s observations of the document recorded inside a stated window, beside the official signals dated inside the same one
Each row is a window of calendar days ending , the day the source-health block below counts its own window to. Every column between the window and the official signals is drawn from the 133 observation(s) of the document this entry holds in total. An observation is counted here only where the class projection places it on the document this entry names.
Window Observations of the document Of those, carrying a digest Of those, carrying a change Direct document Official signals dated inside it
30 calendar days 31 25 0 no detected difference in window not measured
90 calendar days 133 127 1 changed in window not measured
365 calendar days 133 127 1 changed in window not measured

A window is marked changed where at least one observation of the document inside it recorded a change against the previous one; unchanged where the window holds at least one such observation, at least one of them carries a digest of the retrieved bytes, and none recorded a change; undigested where the window holds observations and none of them carries a digest, so no observation in it could be compared with another; and unmeasured where the window holds no observation at all. The word is shorthand for the three counts printed beside it and adds nothing to them. It is a statement about the window and never about the document outside it, which is why a window reaching back before the first observation says so underneath. A mark is derived from the observations a window holds and never from the days it spans; which days inside this entry’s own window hold none is stated by the coverage sentence in Observation history below.

The first observation of the document this entry names is . These windows reach back before it — 90 calendar days · 365 calendar days — so part of the span each names was never watched, and a window with no detected difference inside it says nothing about the days before that first observation.

no detected difference in window — this window holds observations of the document and none of them recorded a change — which is a statement about the window, not about the document outside it · changed in window — at least one observation of the document inside this window recorded a change against the observation before it

No word is attached to the signal count beside it, and none will be. Any word for the size of a count needs either a threshold this record would have authored or a comparison against other entries that would rank the sources against one another; the count and its window are the whole claim. The document column beside it carries a word only because the rule reaching it is printed underneath and can be checked against the counts it stands for.

The last column holds no member on this entry. The zero it holds is named under “Around it” below.

Around it official signals naming this entry, by the class their publisher stated
— 88 of the 88 record(s) the store holds could be tested against this entry, and none names it. That zero is a measurement.
Related sources other entries reachable from this one by a relation a publisher states
1 relation(s) this entry’s own publisher states, 5 citation edge(s) out of its retained text and 0 into it. They reach 6 other entry(ies) this record tracks. Each one is listed with the words that state it and the address they were read from, in the section holding it below.
Related standards which of those entries call themselves a standard, in their own publisher’s word
Of the 6 entry(ies) reached, 3 carry their publisher’s word for a consensus standard, 1 state another class and 2 state none. A related entry is counted as a standard only where that entry’s own record carries the publisher’s word for it, quoted and cited on that entry’s page. Nothing is read from a designator: a title containing the letters of a standards body is not a publisher calling a document a standard. Where an entry states no class, it is counted as stating none rather than as not being one.
Topics record identifiers for publisher-stated values, and the voice each one is in
1 identifier(s), minted by the convention published at /conventions. The values themselves are not listed again here; what this adds is the identifier and the voice it is in. 1 come(s) from a term this document’s own publisher states about it, quoted with its citation lower on this page: topic.cybersecurity.
Before, now and next where the record’s day sits among the publisher-dated facts this entry holds
— This entry holds no publisher-dated lifecycle fact, so no position can be derived. What is absent is a dated statement this record has read.

Next holds the publisher-dated facts this record already carries that fall after the day this record calls today — a stated effective date, a consultation close. Nothing is projected and no step is inferred from a lifecycle: where a publisher has stated no further date, the cell says so, and what is absent is a statement rather than a future.

Subject and class (as stated)

The words this document uses about itself, matched verbatim against its own title. Not a statement of scope, and not a judgment about which organisations or products fall under it: each value quotes the span it was read from and links to where that span was read.

This document does not call itself a regulation, a guidance or a standard, so no class is recorded. It is filed under title states no class.

Citations (within the tracked corpus)

One document's retained text contained a form another document is published under, on the date shown, with the words it was read from. An edge cannot tell the manner of a citation — a document naming another in order to exclude it produces the same entry as one adopting it.

publisher-stated citation relationships — not a regulatory applicability determination The policy, stated once

Cites (as published)

These citations are drawn together on the citation graph, where every row carries the same quote and source.

Stated relations (as published)

Relations this document's own publisher prints. Each quotes the words that state it, links to where they were read, and says which act it was read from. This records what one document says about another and states nothing about the relationship between their requirements. A target the publisher names but this archive does not track is shown under the publisher's own designation.

Family (along publisher-stated edges)

A family forms only along a supersedes, superseded-by or document-history line a publisher prints. A shared title, number, date or prefix forms none. This records what one document's publisher lists about another and states nothing about the relationship between their requirements.

Each edge below is read from the page linked beside it.

Evidence#

Current status#

Recorded as final against the primary source on 8 August 2026.

The text that supported that record, retrieved — by unknown:

field_final_guidance_1: Final

Evidence ladder#

What this record holds for this entry, rung by rung, each mark derived from a field, a count or a stored reading. Rungs in the order the record acquires them, from what an entry is to what has been checked about it. The order is fixed; a rung’s position says nothing about any entry.

The 12 rungs, as marked for this entry
  1. held. identity an address that describes this document rather than a list it sits in This record holds an address that describes this document, and the names it is published under.
  2. held. publisher the body that published it The publishing body is recorded as US Food and Drug Administration.
  3. held. jurisdiction the jurisdiction the publishing body belongs to The jurisdiction is recorded as US.
  4. read, and not there. type the class the document calls itself, quoted from its own title The title was read and it does not call this document a regulation, a guidance or a standard, so no class is recorded.
  5. held. current edition a statement of which edition or revision this record holds The publisher states 1 succession for this document, quoted on this page with the address it was read from.
  6. nothing held. publication date a date the publisher states for this document No reading of a publication date is recorded for this entry.
  7. nothing held. lifecycle signal a stage, step or status wording read from a publisher surface No read of a publisher surface for a stage or status wording is recorded for this entry.
  8. read, and not there. publisher notices official notices the publisher issued about this document A collection of publisher notices has succeeded and none of the records it holds attaches to this entry.
  9. held. observation history a dated series of what the publisher’s address returned This record holds 133 dated records of this document, of 157 records in its series; the rest are classified as records of something other than the document this entry names.
  10. held. text prose retained from the retrieved bytes, against which a quotation can be checked Prose was extracted from the retrieved bytes, so a quotation from this document can be checked against what this record retained.
  11. held. diff a comparison of two retrievals of this document 1 retrieval of this document differed from the one before it.
  12. held. verification a person’s check of this entry against the primary source A person checked this entry against the primary source; the day is recorded above.

✓ held — this record holds it, and the sentence beside it names what from · ✗ read, and not there — a reading ran and did not find it — an absence this record measured · — nothing held — no reading of this rung is recorded — nobody has looked, which is not the same as looking and finding nothing

The first rung a reading ran on and did not find: type — The title was read and it does not call this document a regulation, a guidance or a standard, so no class is recorded.

What the evidence states

  • This record holds an address that describes this document, and the names it is published under.
  • The publishing body is recorded as US Food and Drug Administration.
  • The jurisdiction is recorded as US.
  • The publisher states 1 succession for this document, quoted on this page with the address it was read from.
  • This record holds 133 dated records of this document, of 157 records in its series; the rest are classified as records of something other than the document this entry names.
  • Prose was extracted from the retrieved bytes, so a quotation from this document can be checked against what this record retained.
  • 1 retrieval of this document differed from the one before it.
  • A person checked this entry against the primary source; the day is recorded above.

What it does not state

  • The title was read and it does not call this document a regulation, a guidance or a standard, so no class is recorded.
  • No reading of a publication date is recorded for this entry.
  • No read of a publisher surface for a stage or status wording is recorded for this entry.
  • A collection of publisher notices has succeeded and none of the records it holds attaches to this entry.

Evidence states#

All 8 evidence states, marked against this entry’s own fields. The axis at the top of this page publishes the first of them this entry meets; a state it meets after that is marked as met and not carried, because a state an entry meets and does not carry is not the same fact as one it fails. 7 of the 8 come from the published model and 1 was recorded here. The order, and why it is not a ranking, is stated on the observatory.

  1. not a document not met a body, committee or programme — there is no document here to retrieve, quote or date The object model records this entry’s own type as document.
  2. a register not met retrieved and hashed daily; the tier promises no person-verification The record tier this entry declares is core and its freeze reason is not recorded.
  3. unstated by the publisher not met a surface was read and it states no status term this publisher’s family declares; bounded to the surfaces read This entry carries no status basis and no recorded tool reading that found none, and no status read on file for it reports a surface that states none.
  4. verified by a person (person-ratified) carried a person checked this entry against the primary source on a recorded day This entry records the check as made by a person: checked_by reads human.
  5. source access limited not met the publisher’s licence or its access policy limits what this record takes from the source The freeze reason this entry declares is not recorded, its licence class is open, and its record of whether the publisher excludes automated clients reads not recorded.
  6. publisher metadata not met what is held is metadata the publisher publishes about the document — a catalogue entry or a stage record — not the document The resolution strategy this entry declares is direct_document, what its address points at is declared as document, and no stage the publisher publishes is held for it.
  7. observed also true the document at the address the publisher answered is retrieved and hashed here on a dated series This record holds 127 dated retrievals of the document this entry names, each carrying a digest.
  8. not currently retrievable not met no retrieval of the document this entry names has produced a digest 127 dated retrievals of the document this entry names have produced a digest here.

◆ carried — the entry meets this test and no state before it in the order does, so this is the state its evidence axis publishes · ◇ also true — the entry meets this test as well, and the axis publishes a state that comes before it in the order · × not met — the entry does not meet this test, and the line beside it names what was read

Coverage contract#

Each term states what this record does for this entry and what it does not, derived from the entry’s own fields and its own series. It is a record of coverage, not a finding about the document.

Observed cadence how often this record has reached this entry’s address
Every interval between consecutive days holding an observation is 1 day. The term this record declares for the entry is “monthly”.
Text: public, and retained whether the publisher’s text is public, and whether prose from it is kept here
The publisher’s text is freely reproducible. Prose is retained from the retrieved bytes, so a quotation can be checked against it.
Hash what is digested for this entry, and of what
127 of 133 record(s) classified as being of the document this entry names carry a digest of the retrieved bytes; the entry’s whole series holds 157 record(s), and the rest are classified as records of something other than that document.
Status verification which check this record undertakes for the published status, and which it holds
This entry’s label undertakes to close an open status question by rule on a clock, with its reason, and to re-read a ratification on record against its observation every night. A person’s confirmation is recorded, dated 2026-08-08.
Lifecycle tracked which lifecycle facts this record follows for this entry
This record follows no lifecycle fact for this entry: no effective date, no dated event, no archived version, no publisher stage record and no detected revision is held. That is what has been recorded here, not a reading of what exists. 36 of 132 tracked entries carry at least one such fact.
Known limits the limits this entry’s own record declares
None of the 8 limits this record can record is set on this entry. That is an absence of declared limits, and not a finding that the entry has none.

Why this entry is tracked#

The test an entry is admitted under is published in full, with its negative limb and its worked examples, at the inclusion rule. What this record holds about THIS entry's admission is below, each line naming the store it was read from.

Inclusion-rule limb which of the four limbs was applied
— No field in this record names which limb an entry satisfies, so none is stated for this one. Membership was closed as a human judgment on 2026-08-11, and the four-limb test is applied by a person rather than by code. This entry’s own stated subject is not read as a limb: a title word standing in for a rule would be a classification this record authored.
Admission entry the dated act that added this entry
Recorded on , in this record’s own words: “added after the served page was content-confirmed as the February 2026 edition; the observation series recorded under the June 2025 entry is re-scoped to this one.”. It is listed again under Change history, in the timeline above.
Declared tier-1 list a recorded judgement that this belongs
This entry is not a member of the declared tier-1 list. That list names 37 identifiers, of which 35 resolve to one of the 132 tracked entries, so most of the corpus sits outside it and non-membership says nothing about this entry on its own.
Admissions boundary the jurisdictions this record adds from
This entry’s jurisdiction is US. It is inside the admissions boundary ruled on 2026-08-16, which names 4 jurisdictions — EU · US · UK · International — and which is one of the two admission tests this record enforces in code. The other is that a candidate carry the publisher’s own address: a mention is not a citation.

Observation history#

Observed on 157 occasion(s) since 2026-07-31. 151 produced a content hash. 1 observation(s) are marked ! (digest differed).

························!····································································································································

All 157 marks, one per observation, oldest first. On 6 of the 157 observations the server at the row's address answered a request carrying an earlier reading's validator with 304 "not modified", recorded as "checked, unchanged" on the basis "publisher-validator"; no digest was taken, and the strip draws each of them with the mark for an unchanged one. · unchanged · ! digest differed · ~ fetched but rendered client-side, no hash · × could not be fetched, no hash · / withheld by the publisher’s terms — no fetch made.

Every one of the 95 days from 2026-07-31 to 2026-11-02 holds an observation.

24 of these 157 record(s) are held in this series and left out of every count of the document series , each where the landing URL is a listing or search path. 24 of them were hashed. They are dated to . Nothing was rewritten: each record stands in the store as it was written, with its address, its response and its digest, and the annotation sits beside it. The ruling is of . The document series this entry holds is 133 record(s), and it is what the windows in Publisher neighbourhood above count.

Each mark links to the single observation it stands for, at that observation’s own address. The whole series, with every address, is at /observations/fda-device-cybersecurity-2026. Any two of its retained observations can be set side by side at /compare/fda-device-cybersecurity-2026. The same evidence as a packet, with its refusals and its integrity reference, is at /packet/fda-device-cybersecurity-2026.

Every observation in this series is published, untruncated, at /api/v1/observations.json.

Of the retrievals classified as this document: same digest on 50 observed days, 2026-09-08 to 2026-10-27 (52 retrievals); the last digest before it, recorded on 2026-09-07, differs; 6 later observed days hold no digest of this document. This states what this record retrieved and normalised on those days, and nothing about the document on any other day.

First observed
2026-07-31
Last observed
2026-11-02 (HTTP 304)
Fetch method
direct
Current hash
d34d8c706d885fdf74de22902da334a83590d9d8fbdba8f0ed58ab050c17aa88 Taken on the reading of 2026-10-27. On 2026-11-02 the server answered a request carrying that reading's validator with 304 "not modified", recorded as "checked, unchanged" on the basis "publisher-validator"; no digest was taken that day.
How this series is recorded
Recorded
observations: 157 · carrying a digest: 151 · marked ! (digest differed): 1 · first observed: 2026-07-31
Method
resolution: direct document · watch cadence: monthly · last fetch method: direct
Evidence
The most recent record is addressed at 2026-11-02·1.
Published at
/observations/fda-device-cybersecurity-2026 — every record of this row, with its address. /api/v1/series.jsonl — the same records for every row, one line each. Each observation is addressed by this row’s identifier, the date it was observed, and its sequence within that date — the same key /api/v1/series.jsonl publishes as `sequence`, counted in the order the store recorded them.
SHA-256: d34d8c706d885fdf74de22902da334a83590d9d8fbdba8f0ed58ab050c17aa88 This digest is a leaf of the integrity root, and the command that recomputes it is published at /verify/.

Clauses, definitions and sentences (as printed)#

Each string below is the string served for this entry at /api/v1/clause-anchors.json, /api/v1/definitions.json and /api/v1/modal-sentences.json, one block per observed text, each named by the first 12 characters of its content_hash as the JSON serves it: each clause anchor's id beside its label as the text prints it, each definition's term with its text where the derivation quotes it, and each sentence printing a listed verb that sits under the quote cap. A sentence or definition text over the cap is not cut: it is cited by the clause anchor it sits under, or by the stored reason no anchor is placed, its text withheld, and the count withheld is printed beside the count read. The block of the current text, where one is marked, is the one shown open.

Text b52b706d5cca, first observed 2026-07-31

Clause anchors: no numbering read; 0 placed and 0 withheld.

Definitions: served for the current text of an entry only.

Sentences printing a listed verb: 1 read in this text, 0 quoted and 1 withheld.

  • (no numbering read) 1 withheld: over the quote cap
Text 27c5d1a28e3d, first observed 2026-08-08

Clause anchors: no numbering read; 0 placed and 0 withheld.

Definitions: served for the current text of an entry only.

Sentences: unmeasured, the retained text opens with a PDF file signature ('%PDF-')

Text d34d8c706d88 (current text), first observed 2026-09-08

Clause anchors: read; 6 placed and 0 withheld.

  • 1 1.
  • 2 2.
  • 3 3.
  • 4 4.
  • 5 5.
  • 6 6.

Definitions: 4 read in this text, 0 with the text quoted and 4 with the text withheld.

  • device software function under 6: text withheld (end not delimited: the text before the next definition read does not end with a full stop or a semicolon)
  • end-to-end under 6: text withheld (end not delimited: the text before the next definition read does not end with a full stop or a semicolon)
  • allow-list under 6: text withheld (end not delimited: the text before the next definition read does not end with a full stop or a semicolon)
  • identity management under 6: text withheld (end not delimited: no definition is read after it in this text)

Sentences printing a listed verb: 259 read in this text, 18 quoted and 241 withheld.

  • 6 Likewise, a device with a smaller software risk may have a significant cybersecurity risk.
  • 6 A device should be designed to eliminate or mitigate known vulnerabilities.
  • 6 Such plans must be maintained and updated as design and development progresses (Subclause 7.3.2).
  • 6 Documenting these views in premarket submissions should include both diagrams and explanatory text.
  • 6 Such traceability should exist throughout the cybersecurity risk management documentation.
  • 6 This may change the device’s functionality.
  • 6 This view should include the information recommended in Appendix 2.
  • 6 Each view should include detailed information as recommended in Appendix 2.
  • 6 Such verification shall confirm that the design output meets the design input requirements.
  • 6 For any third-party test reports, manufacturers should provide the original third-party report.
  • 6 Manufacturers should provide or make available SBOM information to users on a continuous basis.
  • 6 This should include notification to the user and logging of relevant information.
  • 6 Additional recommendations on coordinated vulnerability disclosure plans may be found in FDA’sPostmarket Cybersecurity Guidance.
  • 6 Generally, software should be regularly updated to maintain the supportability of the software.
  • 6 Downgrades can allow attackers to exploit prior, less protected versions and should be avoided.
  • 6 The version numbers intended to be installed should themselves be signed or have MACs.
  • 6 Despite best efforts, undiscovered, exploitable vulnerabilities may exist in devices after they are marketed.
  • 6 This should include detailed diagrams and traces for all communication paths as described below.
  • (no clause anchor before this sentence) 3 withheld: over the quote cap
  • 1 1 withheld: over the quote cap
  • 6 237 withheld: over the quote cap

Source health#

Counts and dates over a stated window. No figure here is a mark out of a hundred, no cell is ordered against another, and none of it is a statement about the publisher: a day this record did not reach is a fact about this record’s reach.

Fetch outcomes how the requests in the window answered
140 of 140 fetch records in the 90 calendar days ending carry no error. Of those, 134 produced a digest, and 6 answered 304 to a request carrying an earlier reading's validator, recorded as "checked, unchanged", on which no digest is taken.
Last fetched the most recent record in the whole series
— the latest day this record holds (). The method recorded is direct. What that record returned is in Observation history above.
Address stability where the requests actually landed
140 record(s) in the window recorded the address that answered, across 2 distinct address(es). 7 of them record that the request was redirected before it answered. The most recent answered address is the one this entry declares.
  • https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-management-system-considerations-and-content-premarket 7 record(s), 2026-08-05 to 2026-08-08
  • https://www.fda.gov/media/119933/download 133 record(s), 2026-08-08 to 2026-11-02
Access posture what the publisher declares, and what the requests met
Declared: this record holds no robots statement for this source · crawlable unknown . Met: no request was recorded as refused, over 140 record(s) in the window. A refusal is what one request of this record met on one day; it is not a policy the publisher stated.
Expected and observed cadence the declared term, the days held, and the days holding none
The term this record declares for this entry is monthly. Over its own window, to , 95 of 95 calendar days hold at least one observation. None holds none. Every interval between consecutive days holding one is 1, counted in days. Both figures are stated and the difference between them is not adjudicated here.
Days by outcome each day of the document's window, by what the store holds for it
87 calendar days expected, 2026-08-08 to 2026-11-02 · 87 observed (81 digest-bearing, 6 checked, unchanged (publisher-validator), 0 retrieval failed) · 0 withheld · 0 no request recorded.
  • calendar days expected — one for each calendar day from the first observation classed as the document to the last day the store holds, because the collection is scheduled once a night; not the entry’s declared watch cadence
  • observed — a request for the document is recorded that day, and its record does not state that it was withheld or never left this machine
  • digest-bearing — a digest of the document is recorded that day
  • checked, unchanged (publisher-validator) — observed, and no digest of the document is recorded that day: the request carried an earlier reading’s validator and the server answered 304 “not modified”, which the record keeps as its outcome and basis; stated on a row only where the row has such a day
  • retrieval failed — observed, and no digest of the document is recorded that day
  • withheld — the day’s requests for the document are recorded as withheld, because the host’s filed terms withhold collection; none was sent
  • not sent, name unresolved here — the day’s requests for the document are recorded as never leaving this machine, because the host’s name did not resolve on it; attributable to this record, not to the host; stated on a row only where the row has such a day
  • no request recorded — no request for the document is recorded that day. This states what the store holds, not that no request was sent: the corrections page names the cause of each run of such days, including runs on which requests were sent and their records were not written

API and citation#

Cite this document

Each format carries the permalink and the date this document was observed. The observation date is part of the citation: the underlying source may have changed since.

Plain text

GxPlex. Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions [document record]. Observed 2 November 2026. https://gxplex.com/r/fda-device-cybersecurity-2026 Primary source: https://www.fda.gov/media/119933/download

BibTeX

@misc{gxplexrfdadevicecybersecurity2026,
  author       = {{GxPlex}},
  title        = {{Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions}},
  year         = {2026},
  note         = {document record, observed 2 November 2026},
  howpublished = {\url{https://gxplex.com/r/fda-device-cybersecurity-2026}},
  urldate      = {2026-11-02},
  url          = {https://www.fda.gov/media/119933/download}
}

APA

GxPlex. (2026). Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions [document record]. Retrieved 2 November 2026, from https://gxplex.com/r/fda-device-cybersecurity-2026

JSON

{
  "@context": "https://schema.org",
  "@type": "Dataset",
  "name": "Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions",
  "publisher": "GxPlex",
  "url": "https://gxplex.com/r/fda-device-cybersecurity-2026",
  "temporalCoverage": "2026-11-02",
  "observation": {
    "url": "https://gxplex.com/observations/fda-device-cybersecurity-2026#obs-2026-11-02-1",
    "observedDate": "2026-11-02"
  },
  "isBasedOn": "https://www.fda.gov/media/119933/download"
}

observation.url addresses the single observation this citation rests on.

Every observation of this document is addressed and separately citable at the observation series.

Rights envelope — how this record handles the text of each entry listed
Entrytext_retainedlicence_classquote_allowedsnapshot_available
FDA device cybersecurity (2026)trueopentruetrue

One row, for the entry this page records.

Each value is read by the same function the API reads, and each field is defined in the published schema. None of the four is a grant.

Sources#

Listed primary first, then the further addresses this record holds for this entry, then the route it was found by, then dated third-party copies. Repeated URLs appear once, at their first position.

Last updated: