FSCA vs Recall vs Field Safety Notice

A field safety corrective action (FSCA) is a European Union term with a specific legal definition, and it is not a synonym for a recall. Under Article 2(68) of Regulation (EU) 2017/745 (the Medical Device Regulation, MDR), an FSCA is a corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident associated with a device made available on the market. A recall is one of several things an FSCA can consist of. A field safety notice (FSN) is not an action at all — it is the letter that communicates the action. And the entire vocabulary changes when you cross the Atlantic: the United States has no term called "FSCA" and no document called a "field safety notice." It has corrections and removals reportable under 21 CFR Part 806, and recalls classified under 21 CFR Part 7.

The three terms get conflated constantly, and the conflation is expensive, because each one attaches to a different obligation with a different clock. This page draws the three-way distinction, gives the actual decision criteria, states the EU notification timelines with the conditions that select between them (they are not one number), sets out what an FSN must contain and who reviews it before it goes out, and then maps the whole EU framework onto the US 21 CFR 806 / 21 CFR 7 machinery term by term. If you operate on both markets, the cross-walk table is the part to read first.

The three-way distinction in one table

This is the decision structure. Everything else on this page elaborates one of these rows.

	Field safety corrective action (FSCA)	Recall	Field safety notice (FSN)
What it is	The corrective action itself — the change you make in the field	One possible form of that action: physically getting devices back	The written communication that tells users the action is happening
Legal basis (EU)	MDR Article 2(68); reportable under Article 87(1)(b)	Not separately defined in the MDR — it is an example of an FSCA	MDR Article 2(69); content and review under Article 89(8)
Legal basis (US)	No direct equivalent term; nearest is a reportable correction or removal under 21 CFR 806.10	21 CFR 7.3(g), classified I/II/III under 21 CFR 7.3(m)	No direct equivalent term; nearest is a recall communication under 21 CFR 7.49
Scope relationship	The umbrella in EU vocabulary	A subset of FSCA in EU vocabulary; the umbrella in US vocabulary	Always downstream of an FSCA — never stands alone
Can it happen without the others?	Yes — an FSCA can be a software rollback, a labelling correction or added patient monitoring with no device returned	Not in the EU sense: a safety recall is an FSCA and triggers FSCA obligations	No — an FSN presupposes an FSCA to describe

The single most common error is treating "we are not recalling anything" as meaning "this is not an FSCA." It very often is. The second most common is issuing an FSN and treating that as the whole obligation, when the FSN is the last step in a sequence that starts with notifying competent authorities.

What counts as an FSCA under EU MDR

MDR Article 2(68) defines an FSCA as a corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident, in relation to a device made available on the market. Two elements do the work:

Technical or medical reasons. Commercial motives do not qualify. MDCG 2023-3 Rev.2 states explicitly that removals from the market for purely commercial, non-safety-related reasons are not FSCAs. Discontinuing a product line because it does not sell is not an FSCA; withdrawing it because a sterility barrier fails is.
Prevent or reduce the risk of a serious incident. The trigger is forward-looking. You do not need a serious incident to have happened. If a systematic malfunction is found in devices on the market and those devices have led to, or could lead to, a serious incident, an FSCA is required.

MDCG 2023-3 Rev.2 gives a non-exhaustive list of what an FSCA can consist of. It is much broader than most manufacturers assume:

Return of a device to the manufacturer or supplier, or a recall
A device exchange
A device modification, or a retrofit by the purchaser of a modification or design change
Device destruction
Advice from the manufacturer about how to use the device — additional maintenance information, increased calibration frequency, cleaning instructions, training
Recommended inspections or examinations by the device user, such as regular professional checks of proper functioning in a testing setting
Software or firmware changes related to a safety issue, including a version update or a rollback to an earlier version
Correction of labelling information, such as correcting an originally validated and stated shelf life
Packaging design changes that correct safety-related issues
Instructions about modifications to the clinical management of patients or samples — recalling patients or patient samples for retesting, or reviewing previous test results

That last category matters for implantables and for software as a medical device. MDCG notes that where explanting a device is clinically unjustifiable, special patient follow-up or treatment constitutes an FSCA in its own right — irrespective of whether any affected un-implanted devices remain available for return. A pure "monitor these patients more closely" instruction, with nothing physically returned, is a full FSCA with full notification obligations.

Incident, serious incident, serious public health threat

The FSCA sits inside a definitional stack that also drives the reporting clock. Under the MDR:

Incident — Article 2(64). A malfunction or deterioration in a device’s characteristics or performance, a use error due to ergonomic features, an inadequacy in the information supplied by the manufacturer, or an undesirable side effect.
Serious incident — Article 2(65). An incident that directly or indirectly led, might have led, or might lead to (a) the death of a patient, user or other person; (b) the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health; or (c) a serious public health threat.
Serious public health threat — Article 2(66). MDCG’s worked examples include distribution of non-sterile devices labelled as sterile, and cyberattacks related to life-supporting or life-saving devices.

Incidents that are not serious are not reportable to competent authorities under Article 87(1). They must still be documented and are subject to the trend-reporting requirement in Article 88. MDCG is emphatic that the "not serious" conclusion has to survive a counterfactual test: if the manufacturer cannot exclude that the incident could have led to an Article 2(65)(a)–(c) outcome under less favourable circumstances — without a third-party intervention, or with more vulnerable patients exposed to the same situation — the incident must be treated as serious and reported.

The EU notification clocks are conditional, not a single number

"Report within 15 days" is the answer most secondary sources give, and it is wrong roughly half the time. MDR Article 87(3) to (5) sets three different deadlines, selected by what the incident involved. All are calendar days, and all are outer limits on an obligation that reads "immediately" first.

Situation	Deadline	Clock starts	Provision
Serious incident that did not involve a death or an unanticipated serious deterioration in a person’s state of health	Immediately, and no later than 15 days	The awareness date of the serious incident	MDR Art. 87(3) / IVDR Art. 82(3)
Serious public health threat	Immediately, and no later than 2 days	When the manufacturer becomes aware of the threat	MDR Art. 87(4) / IVDR Art. 82(4)
Death, or an unanticipated serious deterioration in a person’s state of health	Immediately, and no later than 10 days	The awareness date of the serious incident	MDR Art. 87(5) / IVDR Art. 82(5)

Two mechanics that are frequently missed:

The deadline can move backwards as facts arrive. MDCG’s worked example: a serious incident is initially assessed as non-fatal and carries the 15-day deadline; the manufacturer then learns the patient died. The consequence is now a death, so the applicable deadline becomes 10 days from the awareness date of the serious incident. MDCG’s conclusion is that it is the earliest date of reporting that should be considered — the clock does not restart, it tightens.
Uncertainty is not a reason to wait. Under Article 87(7), where the manufacturer is uncertain whether an incident is reportable, it must nevertheless submit a report within the timeframe required by Article 87(2) to (5).

How the days are actually counted

The periods are computed under Regulation (EEC, Euratom) No 1182/71. Article 3(3) means the period runs from the day after the triggering event rather than the day itself; Articles 3(4) and 3(5) mean that where the last day of the period is a Saturday, Sunday or public holiday, the period ends with the expiry of the last hour of the following working day. This is not a detail invented by guidance — it is the general EU rule on time limits, and MDCG 2023-3 Rev.2 cites it directly for vigilance deadlines. It is also the reason a "15-day" deadline can land on day 17 or 18 on a calendar.

Who you notify, and about what

Article 87(1) sets out two distinct reporting duties, and they are often collapsed into one:

Article 87(1)(a) — serious incidents involving devices made available on the Union market, on the clocks above. These go on the Manufacturer Incident Report (MIR) form, which became applicable on 1 January 2020.
Article 87(1)(b) — field safety corrective actions in respect of devices made available on the Union market. These go on the field safety corrective action form, a separate form from the MIR.

For the FSCA report the addressees are set by where the action lands, not by where the incident happened. Per MDCG 2023-3 Rev.2, drawing on Article 89(2) and (3):

For a serious incident, the evaluating competent authority is that of the Member State in which the serious incident occurred.
For an FSCA, it is the competent authority or authorities of the Member States in which the FSCA is being or is to be undertaken — that is, the Member States where devices affected by the FSCA were made available.
Always additionally: the competent authority of the Member State where the manufacturer or its authorised representative has its registered place of business, even where that Member State is not among those in which the FSCA is being undertaken.

The manufacturer must inform those authorities without delay, and must separately ensure the FSCA is communicated without delay to affected users through an FSN.

The third-country rule that catches US manufacturers

Article 87(1)(b) reaches beyond the Union. Where an FSCA is undertaken in a third country and the device is also legally made available on the Union market, all relevant competent authorities must be notified — unless the reason for the FSCA is limited to devices made available in the third country. MDCG’s worked example is exactly the transatlantic case: a recall in a third country due to a malfunction affecting certain lots, where those lots were also placed on the Union market, requires notification of all relevant EU competent authorities.

In practice this means a US-initiated Part 806 correction or removal, or a Part 7 recall, can independently trigger an EU FSCA notification for the same event, on EU deadlines, using EU forms. The two regimes do not substitute for each other.

Safety-related preventive and corrective actions under Article 83(4)

There is a third reporting channel that is easy to miss. Where a manufacturer identifies a need for a safety-related preventive or corrective action linked to a serious incident or an FSCA — Article 83(4) MDR, second sentence — that information must be reported to competent authorities using the relevant vigilance report, meaning the MIR or the FSCA form, with a description of the action and the associated reference or case number. Preventive and corrective actions falling under the first sentence of Article 83(4) can instead be conveyed through the periodic safety update report (PSUR) or the post-market surveillance report. MDCG 2022-21 is the PSUR guidance that covers this.

The field safety notice: content, review, and language

An FSN is defined at MDR Article 2(69) as the communication sent by the manufacturer to users or customers in relation to an FSCA. Four operational requirements govern it:

Timing. The FSCA must be communicated without undue delay for the attention of users or customers of the device in question.
Content. The requirements for FSN content are set out in the second paragraph of Article 89(8) MDR (Article 84(8) IVDR). Consult that paragraph directly — it is the controlling list, and a template that has not been checked against it is a liability.
Pre-issue review by the competent authority. Under the first paragraph of Article 89(8), manufacturers must — except in cases of urgency — submit the draft FSN to the evaluating competent authority to allow it to review and comment. This is the requirement with no US analogue at all, and the one that most often surprises manufacturers importing a US recall-communication process into Europe.
Consistency across Member States. Unless duly justified by the situation of an individual Member State, the content of the FSN must be consistent in all Member States. MDCG’s example of a valid justification is narrow: a translation error in the instructions for use that appears only in certain languages and therefore affects only specific countries.

Where the case falls under Article 89(9) — certain serious incidents or FSCAs considered to be of concern, where evaluating competent authorities participate in a coordinated assessment under a designated coordinating competent authority — the draft FSN goes to the coordinating competent authority, but the final FSN must be transmitted to all evaluating competent authorities.

The United States: two separate regimes, neither called an FSCA

US device regulation splits the same subject matter across three parts of Title 21, and the vocabulary does not line up with Europe’s. For the surrounding quality-system context, see the 21 CFR Part 820 subpart map and QMSR transition.

21 CFR Part 806 — reports of corrections and removals

Part 806 implements section 519(g) of the Federal Food, Drug, and Cosmetic Act. It requires device manufacturers and importers to report certain corrections and removals to FDA, and to keep records of all corrections and removals whether or not they are reportable (21 CFR 806.1(a)). The two defined action types are narrower than they sound:

Correction — 21 CFR 806.2(d): repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location.
Removal — 21 CFR 806.2(j): the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.

The reporting trigger (21 CFR 806.10(a)) is a correction or removal initiated either to reduce a risk to health posed by the device, or to remedy a violation of the act caused by the device which may present a risk to health. "Risk to health" has its own two-tier definition at 806.2(k): a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death; or that use or exposure may cause temporary or medically reversible adverse health consequences, or an outcome where the probability of serious adverse health consequences is remote. Those two tiers deliberately mirror the Class I and Class II recall definitions in Part 7.

The clock is 10 working days from initiating the correction or removal (21 CFR 806.10(b)) — working days, not calendar days, which is the opposite convention from the EU. If the same correction or removal is later extended to additional lots or batches of the same device, an amendment citing the original report number is due within 10 working days of initiating the extension (806.10(d)).

Section 806.10(c) prescribes thirteen content elements, including the unique device identifier (see UDI requirements), the total number of devices subject to the action, the names and addresses of all domestic and foreign consignees with dates and quantities distributed to each, and copies of all communications regarding the correction or removal. Where required information is not immediately available, 806.10(c)(13) requires a statement of why and when it will be submitted — the report is not deferred while you assemble the consignee list.

Four exemptions from the reporting requirement (21 CFR 806.1(b)): actions taken to improve performance or quality that do not reduce a risk to health or remedy a violation; market withdrawal as defined in 806.2(i); routine servicing as defined in 806.2(l); and stock recovery as defined in 806.2(m). Note that 806.2(l) treats repairs of an unexpected nature, replacement of parts earlier than their normal life expectancy, and identical repairs or replacements of multiple units as not routine servicing — the exemption is narrower than the phrase suggests. Separately, 806.10(f) removes the duplicate-filing problem: no Part 806 report is required if a report of the same correction or removal is required and has been submitted under Part 803 or Part 1004.

Non-reportable actions still generate records (21 CFR 806.20). The record must include the device identification, a description of the events, a copy of all communications, and — the element inspectors actually look for — a written justification for not reporting, containing conclusions and any follow-ups, reviewed and evaluated by a designated person. Retention is 2 years beyond the expected life of the device, even if the firm has ceased manufacturing or importing it, and the records transfer to a new manufacturer or importer. Submitted reports are publicly disclosable under Part 20, with trade-secret and personal-privacy redactions (806.40).

21 CFR Part 7 — recalls and their classification

A recall at 21 CFR 7.3(g) is a firm’s removal or correction of a marketed product that FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g. seizure. It expressly excludes market withdrawal and stock recovery. Note the definitional consequence: in US usage a recall requires a violative product. A field action on a compliant product that nonetheless reduces a risk to health is a reportable correction or removal under Part 806 without necessarily being a Part 7 recall.

Classification is FDA’s, not yours (21 CFR 7.3(m)):

Class	Criterion
Class I	A reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class II	Use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote
Class III	Use of, or exposure to, a violative product is not likely to cause adverse health consequences

A recall strategy (21 CFR 7.3(l) and 7.42) is developed by the recalling firm for a firm-initiated recall, taking account of the health hazard evaluation, ease of identifying the product, how obvious the deficiency is to the user, how much product remains unused in the marketplace, and continued availability of essential products. FDA reviews its adequacy, but 7.42(a)(2) is explicit that a firm should not delay initiating a recall pending that review. The strategy addresses three elements:

Depth of recall (7.42(b)(1)) — consumer or user level, retail level, or wholesale level.
Public warning (7.42(b)(2)) — reserved for urgent situations where other means of preventing use appear inadequate; issued either through general news media or through specialised media aimed at physicians, hospitals and similar audiences.
Effectiveness checks (7.42(b)(3)) — verification that all consignees at the specified recall depth received notification and took appropriate action, at one of five codified levels.

Level	Proportion of consignees contacted
Level A	100 percent of the total number of consignees
Level B	Greater than 10 percent and less than 100 percent, determined case by case
Level C	10 percent
Level D	2 percent
Level E	No effectiveness checks

Recall communications (21 CFR 7.49) must promptly notify each affected direct account, convey that the product is subject to recall, that further distribution or use should cease immediately, that the account should notify its own customers where appropriate, and what to do with the product. The regulation goes as far as prescribing envelope formatting: conspicuously marked, preferably in bold red type, on both letter and envelope, and marked "urgent" for Class I and Class II recalls. It must not contain promotional material or qualifications that detract from the message, and it must give the recipient a ready means of reporting back.

Status and termination. Recall status reports go to the appropriate FDA district office at an interval FDA specifies, generally between 2 and 4 weeks (7.53). A recall terminates when FDA determines that all reasonable efforts have been made in accordance with the recall strategy; written notification of termination is issued by the district office (7.55). Part 7 also carries explicit preparedness guidance at 7.59: maintain a written recall contingency plan, code products for positive lot identification, and keep distribution records long enough to locate product.

One structural point that trips people up: Part 7 recalls are voluntary in form — firm-initiated under 7.46, or FDA-requested. FDA’s power to order a device recall sits separately in 21 CFR Part 810 under section 518(e) of the act, and is a distinct proceeding, not an escalation of a Part 7 recall.

Do not confuse the two "MDR"s

In US device practice, MDR means Medical Device Reporting — the adverse-event reporting system under 21 CFR Part 803. In EU practice, MDR means the Medical Device Regulation, (EU) 2017/745. A sentence such as "we filed an MDR" means something completely different depending on which side of the Atlantic the speaker sits, and the confusion is common enough in joint EU/US quality systems that it is worth writing the expansion out in procedures. The functional counterpart of a Part 803 MDR report in Europe is the MIR under Article 87(1)(a) — not the FSCA form.

EU to US cross-walk

This is the table to put in a bilateral SOP. Nothing here is a one-to-one identity; the third column is where the mapping actually breaks.

EU (MDR 2017/745)	US (21 CFR)	Where the mapping breaks
Field safety corrective action, Art. 2(68)	Reportable correction or removal, 806.10(a)	The EU trigger is the risk of a serious incident; the US trigger is a risk to health or a violation of the act that may present one. An action can qualify under one and not the other.
Recall (as one form of FSCA)	Recall, 7.3(g)	EU: recall is a subset of FSCA. US: recall is the broader public-facing concept but is limited to violative product; a non-violative safety correction is a Part 806 matter, not a Part 7 recall.
Field safety notice, Art. 2(69) / 89(8)	Recall communication, 7.49	The FSN draft must go to the evaluating competent authority for review and comment before issue, except in urgency. Nothing in Part 7 requires FDA to pre-review a recall communication.
Serious incident report (MIR), Art. 87(1)(a)	Medical Device Report, 21 CFR Part 803	Different definitions of what is reportable and different clocks; a single event commonly generates both, independently.
Art. 87(3)–(5): 15 / 2 / 10 calendar days, selected by outcome	806.10(b): 10 working days from initiating the action	Different day-counting conventions and different start events — EU runs from awareness of the incident, US from initiation of the corrective action.
No recall classification scheme	Class I / II / III assigned by FDA, 7.3(m)	The EU’s risk gradation lives in the reporting deadline (serious public health threat vs death vs other serious incident), not in a post-hoc class assigned by the regulator.
Competent authority evaluates the adequacy of the FSCA, Art. 89(2)–(3)	Firm conducts effectiveness checks at Level A–E, 7.42(b)(3)	The US prescribes a sampling percentage; the EU prescribes an authority judgement. Neither substitutes for the other in a bilateral action.
Trend reporting for non-serious incidents, Art. 88	No direct equivalent	US non-reportable corrections and removals generate a record under 806.20; there is no statutory statistical-trend report obligation of the Art. 88 shape.
Commercial, non-safety removals excluded from FSCA	Market withdrawal (7.3(j), 806.2(i)) and stock recovery (7.3(k), 806.2(m)) excluded	Both regimes carve out commercial actions, but the US also carves out routine servicing — with a narrow definition that excludes unexpected repairs and multi-unit identical repairs.
Notify CAs where the FSCA is undertaken, plus the CA of the registered place of business	Notify FDA; district office for Part 7, central submission for Part 806	The EU addressee set is a function of market distribution and can be a dozen authorities; the US is a single agency.

A working sequence for a bilateral field action

The order below reflects where the deadlines actually bite. It assumes a device on both the EU and US markets.

Classify the information first, not the action. Is it an incident under Art. 2(64)? If yes, is it a serious incident under Art. 2(65)? That answer sets the EU clock before you have decided what corrective action to take.
Start the EU incident clock immediately. If uncertain about reportability, report anyway within the applicable timeframe (Art. 87(7)). Two days if a serious public health threat is in play — that deadline runs from awareness of the threat, not from a completed investigation.
Decide whether a field action is required. If action is needed for technical or medical reasons to prevent or reduce the risk of a serious incident, it is an FSCA regardless of whether anything is physically returned.
Determine the EU addressee set. Every Member State in which the FSCA is or will be undertaken, plus the Member State of the manufacturer’s or authorised representative’s registered place of business. Notify without delay, on the FSCA form.
Draft the FSN and route it for competent-authority comment before issue, unless the case is genuinely urgent. Check the draft against the content list in the second paragraph of Art. 89(8). Keep content consistent across Member States.
In parallel, run the US determination. Is the action a correction or a removal under 806.2? Was it initiated to reduce a risk to health or remedy a violation that may present one? If yes, the Part 806 report is due within 10 working days of initiation — which may well fall before the EU FSN has cleared review.
If the product is violative, treat it as a Part 7 recall as well. Notify the FDA district office, build the recall strategy, set the effectiveness-check level, and format the recall communication to 7.49.
Check the third-country trap in both directions. A recall executed only in the US still requires EU competent-authority notification if the affected lots were also made available on the Union market and the reason is not limited to the third-country product.
Feed the outcome back into the QMS. The corrective action, its effectiveness verification and the closure evidence belong in your CAPA and nonconformity records under ISO 13485, not only in the regulatory file.

Where this sits in the post-market system

An FSCA is an output of post-market surveillance, not a standalone event. It draws on the same design and risk records that ISO 13485 requires you to maintain, is executed through the CAPA machinery those quality systems define, and is bounded by the device identification and traceability infrastructure — UDI and distribution records — that determines whether you can find the affected units at all. 21 CFR 806.10(c)(5) and 806.20(b)(2) both ask for the UDI by name; 21 CFR 7.59(b) asks for coding sufficient for positive lot identification. A field action is where traceability that looked adequate on paper is tested.

The regime is also distinct from drug-side safety reporting. If you are coming from a pharmaceutical background, the closest analogue to the MIR is the ICSR, and the closest analogue to the FSN is a Direct Healthcare Professional Communication — but the device framework has no PSUR-equivalent that substitutes for expedited FSCA notification. See pharmacovigilance in clinical research for the drug-side structure, and GxP compliance for how the surrounding practice frameworks divide up.

Forms, databases and a note on currency

The MIR form and its help text are published on the European Commission’s medical devices website; the MIR became applicable on 1 January 2020. MDCG 2023-3 Rev.2 (January 2025) refers to MIR version 7.3.1 as being finalised at the time of writing and directs readers to the Commission site for the published version — check the current version before submitting rather than relying on any secondary source, including this page. FSCAs are reported on a separate field safety corrective action form.

Eudamed’s post-market surveillance and vigilance module is being rolled out gradually; Regulation (EU) 2024/1860 amended the MDR and IVDR as regards that gradual roll-out. Until the vigilance module is mandatory, MDCG advises manufacturers and notified bodies to agree how vigilance information is provided to the notified body that issued the certificate, and permits continuing the procedures used under the previous Directives. Roll-out status changes; verify it against the Commission’s Eudamed pages rather than assuming — as of 26 August 2026 four modules are mandatory but the vigilance module is still in development and not open even for voluntary use, as set out in our module-by-module Eudamed status and registration guide.

One sourcing caveat, stated plainly. The article and paragraph numbers, the definitions and the Article 87(3)–(5) deadlines on this page are taken from MDCG 2023-3 Rev.2, the Medical Device Coordination Group’s own endorsed guidance, which quotes and cites them directly. The consolidated MDR text on EUR-Lex was not reachable at the time of writing to re-check the wording verbatim. MDCG guidance is not legally binding — the document says so itself, and only the Court of Justice of the European Union can give binding interpretations of Union law. For anything load-bearing, read Articles 2, 83, 87, 88 and 89 of Regulation (EU) 2017/745 in the consolidated EUR-Lex text.

Frequently asked questions

Is every recall a field safety corrective action?

In EU terms, a safety-motivated recall is an FSCA — MDCG 2023-3 Rev.2 lists recall among the examples of FSCA measures. A removal from the market for purely commercial, non-safety-related reasons is not. In US terms the relationship inverts: a Part 7 recall requires a violative product, while a non-violative correction or removal that reduces a risk to health is reportable under Part 806 without being a recall.

Is an FSCA the same as a field safety notice?

No. The FSCA is the action; the FSN is the communication that tells users about it. MDR Article 2(68) defines the former and Article 2(69) the latter. You can have an FSCA that has not yet produced an FSN — briefly, while the draft is with the competent authority for comment — but you cannot have a legitimate FSN with no FSCA behind it.

What is the deadline to report an FSCA to a competent authority?

The MDR requires notification without delay, and MDCG 2023-3 Rev.2 restates this. The specific numeric deadlines in Article 87(3) to (5) — 15, 2 and 10 calendar days — attach to serious incident reporting, not to the FSCA report itself. Treat the FSCA notification as immediate: in practice it is frequently made alongside or ahead of the related serious-incident report.

Does a software update count as an FSCA?

Yes, where it is safety-related. MDCG 2023-3 Rev.2 lists changes of software or firmware in the device related to a safety issue, explicitly including a version update or a rollback to an earlier version, among the examples of FSCA measures. A routine feature release with no safety rationale is not.

If I report to FDA, do I still have to notify EU competent authorities?

Yes, if the device is legally made available on the Union market and the reason for the action is not limited to the product made available in the third country. Article 87(1)(b) MDR covers FSCAs undertaken in third countries, and MDCG’s worked example is a third-country lot recall where the same lots reached the Union market. The regimes are cumulative, not alternative.

Are non-serious incidents reportable in the EU?

Not under Article 87(1). They must be documented, and they fall under the trend-reporting requirement in Article 88 MDR (Article 83 IVDR). But MDCG requires the "non-serious" determination to survive a counterfactual test: if you cannot exclude that the incident might have led to death, serious deterioration or a serious public health threat in less favourable circumstances, it is a serious incident.

What has to be in a field safety notice?

The content requirements are in the second paragraph of Article 89(8) MDR (Article 84(8) IVDR). Beyond content, three procedural requirements apply: submit the draft to the evaluating competent authority for review and comment except in cases of urgency; keep content consistent across Member States unless a Member-State-specific situation duly justifies otherwise; and, in Article 89(9) coordinated-assessment cases, send the draft to the coordinating competent authority but the final FSN to all evaluating competent authorities.

How many consignees do I have to check up on after a US recall?

Whatever the recall strategy specifies, from the five codified levels at 21 CFR 7.42(b)(3): Level A is 100 percent of consignees, Level B is a case-by-case percentage greater than 10 and less than 100, Level C is 10 percent, Level D is 2 percent, and Level E is no effectiveness checks. The level is set in the strategy alongside recall depth and the public-warning decision, and FDA reviews the strategy’s adequacy.

Do I have to keep records of corrections and removals I did not report?

Yes. 21 CFR 806.20 requires a record for every non-reportable correction or removal, including a written justification for not reporting that contains conclusions and any follow-ups and has been reviewed and evaluated by a designated person. Retention is 2 years beyond the expected life of the device, even after you stop making or importing it, and the records transfer with the product to a new manufacturer or importer.

Primary sources

Regulation (EU) 2017/745 (MDR) — Articles 2(64)–2(69) (definitions), 83 (post-market surveillance system), 87 (reporting of serious incidents and FSCAs), 88 (trend reporting), 89 (analysis of serious incidents and FSCAs, including FSN requirements at 89(8) and coordinated assessment at 89(9)).
MDCG 2023-3 Rev.2, Questions and Answers on vigilance terms and concepts (January 2025) — the source for the reporting-timeline mechanics, the FSCA examples list, the addressee rules and the third-country FSCA guidance used on this page.
21 CFR Part 806 — Medical Devices; Reports of Corrections and Removals.
21 CFR Part 7 — Enforcement Policy, including Subpart C on recalls (7.3 definitions, 7.42 recall strategy, 7.46 firm-initiated recall, 7.49 recall communications, 7.53 status reports, 7.55 termination, 7.59 industry guidance).
21 CFR Part 810 — Medical Device Recall Authority, the mandatory-recall proceeding under section 518(e) of the Federal Food, Drug, and Cosmetic Act.
21 CFR Part 803 — Medical Device Reporting, the US adverse-event channel distinct from Part 806.