1Is it reportable? Decide in this order.
Part 806 binds manufacturers, including specification developers and relabellers, importers, and applicants for combination products with a device constituent part.¹²³ Only the firm that initiates an action reports it, so a kit maker need not repeat its supplier’s report.⁴ Record the answer to each step.
- Is it a correction or a removal? A correction repairs, modifies, adjusts, relabels, destroys or inspects a device, including by patient monitoring, without moving it from its point of use; a removal moves it elsewhere. A software update pushed to installed devices is therefore a correction.¹ An inspection to find out whether a risk exists is not reportable; one started because of a known risk is a correction.⁴
- Is it routine servicing? Scheduled maintenance, calibration, end-of-life parts and normal wear are exempt; unexpected repairs, early part replacement and “identical repairs or replacements of multiple units” are not.⁵¹
- Has any of the lot, model or code left your control? If none has, it is an exempt stock recovery. If any has, units still in your warehouse belong to the same action.¹
- Did you start it to reduce a risk to health? Part 806 defines that risk in the words FDA uses for Class I and II recalls, and use error still counts; judge it with the test below.¹⁶
- If not, did you start it to remedy a violation that may present a risk to health? A device that fails its specifications or does not perform as represented is generally adulterated; false or misleading labelling misbrands it.⁷ A minor violation FDA would not act on makes it an exempt market withdrawal.¹
- Is it only an improvement? Improving performance or quality without reducing a risk or remedying a violation is exempt; FDA calls this an enhancement. Extending an implant’s represented 5-year battery life to 5.5 years is one; replacing batteries that fail early is a recall.⁵⁷
- Was a report of this correction or removal already required and submitted under Part 803 or Part 1004, or did FDA order the action under Part 810? Then no 806 report is needed.²⁶
A yes at step 4 or 5 with no exemption means a report within 10 working days; anything else, except routine servicing, needs the record described below.²⁸
1.1Judging step 4: the risk to health.
FDA’s health hazard evaluation weighs whether anyone has already been harmed, whether existing conditions could expose people to the hazard, who is exposed and most at risk, and how serious, how likely and how immediate or long-range the harm would be.⁹ Answer each in writing.
| If the evaluation finds | Recall class | Under Part 806 |
|---|---|---|
| Reasonable probability of serious harm or death | Class I | Report |
| Temporary or medically reversible harm, or serious harm remote | Class II | Report |
| Not likely to cause adverse health consequences | Class III | Record only |
“Serious” has a fixed meaning. FDA said in 1997 that it intended “serious adverse health consequences” to mean the same as “serious injury” under the MDR rule:⁴ an injury or illness that is life-threatening, causes permanent impairment or damage, or needs medical or surgical intervention to prevent it.¹¹ See also FDA recall classes.
2When the 10 working days start.
The regulation says “within 10-working days of initiating” and does not define initiating.² FDA did, when it issued the rule: initiation is “that moment in time when a firm makes the first contact within or outside the firm that begins the correction or removal action.”⁴ An internal instruction to begin the work counts, so the clock can start before any customer hears of it.
- Working days. FDA chose working days so reports have time “when holidays or weekends intervene”.⁴
- Deciding there is no risk. FDA said “The only way” a started action escapes reporting is a finding within the 10 days that the device “did not present a risk to health, or there was no violation of the act that could present a risk to health.”⁴
- Adding lots. Extending the same action to more lots needs an amendment citing the original report number within 10 working days of starting the extension.² A new triggering event, such as the same defect in lots released later, needs its own report unless the timing lets one report cover both.⁴
- Telling FDA sooner. A firm that believes its product is violative “is requested to notify immediately” its FDA office.¹² Form 5072 asks for the draft letter and recall strategy “prior to initiation”, and for a correction plan to “seek concurrence by your FDA Recall Coordinator prior to implementation”.¹³ The 10 days are a limit, not a reason to wait.
3The report: what 806.10(c) and Form 5072 ask for.
FDA encourages emailing Form FDA 5072, which holds up to 20 products, to your Division Recall Coordinator; eSubmitter is the alternative.⁶ The form (version 02/25) lists four regional mailboxes by the recalling firm’s state, such as oii-
The report must carry the 13 items in 806.10(c), and the form asks for more. The entries are for an invented correction, Corvane Medical’s AP-2 infusion pump, timed in the next section.
| Item | What it must contain | Example entry |
|---|---|---|
| (1) Report number | Registration number (or FEI on the form), date, sequence number, C or R | 1234567- |
| (2) Firm and contact | Firm’s name, address and phone; who runs the action, with title and contact details | Corvane Medical; director of field actions |
| (3) Device | Brand name, common or classification name, intended use | AP-2 infusion pump; intended use as cleared, word for word |
| (4) Marketing status | 510(k), PMA or preamendment status, and listing number | 510(k) and listing numbers of the cleared model |
| (5) Identification | UDI, or model, catalogue, lot or serial numbers | UDI-DI and 1,410 serial numbers in a spreadsheet |
| (6) Manufacturer | Name, address, phone and contact, if not the submitter | Same as (2) |
| (7) Event and actions | What happened, and the actions taken and expected | Alarm delay, its cause, firmware 4.2.1, updates complete by 31 July |
| (8) Illness or injury | Any illness or injury, with MDR numbers | None; three malfunction MDRs, numbers listed |
| (9) Quantities | Number made or distributed that the action covers, per lot | 1,410: 1,240 at consignees, 170 in the warehouse |
| (10) Dates | Manufacture or distribution dates; expiry or expected life | Shipped 2 March to 29 May 2026; expected life 7 years |
| (11) Consignees | Every domestic and foreign consignee, with dates and quantities | 37 consignees in a sortable spreadsheet |
| (12) Communications | Copies of all communications, and recipients not in (11) | The 15 June letter as sent, service bulletin, call script |
| (13) Gaps | Why anything is missing and when it will follow | Two distributors’ onward consignees, due 2 July |
| Form: hazard | Whether you did a health hazard evaluation, with a copy | Yes: temporary harm possible, serious harm remote |
| Form: root cause | Details, if you have found it | Occlusion threshold set too high in firmware 4.2 |
| Form: scope | The criteria used to set the scope | Every pump running firmware 4.2, by serial number |
| Form: depth | The customer level reached; a justification if only wholesale | Hospitals, including the two distributors’ customers |
| Form: effectiveness | How you will check it worked, and chase non-responders | Service records reconciled to all 1,410 serials |
The form also asks how the problem was discovered, for complaint and MDR counts, the plan for returned stock, the final CAPA, and a press release or a reason for not issuing one.¹³ Four calls here are worth copying.
- One number, two formats. The regulation writes 1234567-
6/ 1/ 97- 001- C; Form 5072 wants “[Registration # or FEI]/ mmddyyyy/ RorC/ #####”. Use the form’s pattern in its field, and the same number in any amendment.²¹³ - The 170 warehouse pumps are in it. The same model and firmware had shipped, so they are not a stock recovery.¹
- Three malfunction MDRs, though serious harm is remote. Part 803 needs one when a recurrence would be likely to cause or contribute to death or serious injury,¹⁵ but FDA’s MDR guidance also counts any malfunction that leads to an action under section 519(g), which Part 806 implements.¹⁶⁵
- Item (12) is the letter exactly as sent. FDA cited Contec Medical Systems in October 2025 because a paragraph in its customer letter was missing from the copy it sent FDA.¹⁷
4Example: a software correction, reported on time.
Corvane’s registration number is the regulation’s own placeholder.²
| Date (2026) | What happened | Clock |
|---|---|---|
| 27 May to 1 June | Three complaints of late occlusion alarms at 0.5 mL/h arrive on 27, 28 and 29 May; trending links them on 1 June | MDR clocks start at each receipt |
| 2 to 9 June | Investigation: firmware 4.2 can take 180 minutes to alarm, against 60 in the labelling; hazard evaluation done | Not started: investigating is not correcting |
| Wed 10 June | Draft letter, recall strategy and correction plan emailed to the regional recall mailbox | Not started: the form asks for these “prior to initiation” |
| Thu 11 June | Firmware 4.2.1 approved; the service manager emails field engineers to schedule updates | Day 0 |
| Mon 15 June | Urgent Medical Device Correction letter to 37 consignees | Day 2 |
| Fri 19 June | Juneteenth, a federal holiday | Not counted |
| Mon 22 June | Three malfunction MDRs submitted | 24 to 26 days after receipt |
| Wed 24 June | Form 5072 emailed, MDR numbers included | Day 8 of 10 |
| Tue 30 June | Defect confirmed in firmware 4.1 pumps; the same update extended to two more consignees | Day 0 of the extension |
| Fri 3 July | Independence Day holiday observed | Not counted |
| Mon 13 July | Amendment citing the original report number | Day 8 of 10 |
Both routes in 806.10(a) apply: the pumps do not perform as represented, and the update reduces a risk to health.²⁷ The MDR clock runs separately, 30 calendar days from receiving information that reasonably suggests a reportable malfunction; counting from each complaint’s receipt spares Corvane any argument about when the correction made them reportable.¹⁵
5The record when you don’t report.
Every correction or removal you start and do not report needs a record under 806.20, market withdrawals and stock recoveries included.⁸¹ FDA uses these records “to audit the manufacturer’s determination that a report of correction or removal was not required.”⁴
| 806.20(b) | What to write | Example: wrong address on cartons |
|---|---|---|
| (1) Device | Brand, common and classification names, product code if known, intended use | AP-2 infusion pump, as listed |
| (2) Identification | UDI, or model, catalogue, lot or serial numbers | Three carton lots |
| (3) Event and action | What happened, and what was and will be done | Old site address on outer cartons; distributors apply corrected labels |
| (4) Justification | Why it was not reported, with conclusions and follow-ups, reviewed by a designated person | Minor labelling violation, as in FDA’s example; signed by the regulatory affairs lead |
| (5) Communications | Copies of all communications | Distributor notice and relabelling instructions |
Keep the record for two years beyond the device’s expected life, even after you stop making or importing it, and pass it on if the device changes hands.⁸
6Judgement calls FDA has ruled on.
Calling an action an enhancement does not settle it:
“Even if you categorized the software update as a “device enhancement,” the evidence still indicates that a report of correction or removal was required to have been submitted to FDA because you initiated the correction (i.e., updated the software) in order to reduce a risk to health posed by the device (i.e., inaccurate insulin dosing).” Beta Bionics, Inc., warning letter, 28 January 2026¹⁸
A low-risk conclusion is tested against what you did. A mobile X-ray maker called slow, unintended movement no risk to safety, yet made two corrections and sent a service note. FDA disagreed:
“Our assessment concluded that the unintended movement presents a risk to health and your firm’s actions were initiated to reduce the risk to health.” Sedecal S.A., warning letter, 5 May 2025¹⁹
- You don’t classify your own recall. Beta Bionics said it was conducting a Class III recall. FDA replied that “a recall’s classification is assigned by FDA, not the recalling firm” and that a voluntary recall does not exempt a firm from Part 806.¹⁸
- Replacements count. Sending clean units to customers who returned soiled refurbished ones was a reportable correction or removal.²⁰
- Late is a violation even once filed. Philips reported in January 2025 an action whose customer letters went out in March 2024, which FDA called “not within the 10 working-day timeframe.”²¹
- A bug list can be a correction. FDA said a software “bug list” sent to customers could be one if it amounts to relabelling, reportable only when started to reduce a risk.⁴
7FDA, EU MDR and Great Britain compared.
| Point | FDA, 21 CFR 806 | EU MDR | Great Britain |
|---|---|---|---|
| Trigger | Reducing a risk to health, or a violation that may present one | Field safety corrective action “to prevent or reduce the risk of a serious incident” | Field safety corrective action, defined the same way |
| Timing | Within 10 working days of initiating | “in advance of the field safety corrective action being undertaken”, unless urgent | Before taking it, unless urgent |
| What goes in | 13 items, every consignee and all communications | FSCA report and the draft field safety notice | Initial report and proposed field safety notice |
| Source | Part 806, issued 1997; reports due since 18 May 1998 | Articles 87 and 89 | Regulation 44ZJ, from 16 June 2025 |
8What changed in 2024 to 2026.
- Early Alerts. Since 29 September 2025, after a pilot announced on 21 November 2024, CDRH issues public Early Alerts for potentially high-risk removals or corrections of any device, which can precede FDA’s decision on whether they are recalls.²⁵
- Part 806 itself has not changed. It was last amended on 1 April 2019.⁵
9How it runs in Seal.
In Seal, a correction or removal runs as one recall case, from the initiating signal and health-hazard evaluation through affected lots, distribution, consignee responses, reconciliation, status reports and termination. The case can be configured with product- and jurisdiction-
For device makers, the medical device blueprint records complaints as structured data, and field safety corrective action documentation can be prepared from the complaint trend, affected lots and distribution records, with notification tracking. The team assesses the signal and decides the action.
References
- 121 CFR 806.2, Definitions, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ section- 806. 2 (read 8 November 2026) - 221 CFR 806.10, Reports of corrections and removals, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ section- 806. 10 (read 8 November 2026) - 321 CFR 4.102, What reports must you submit to FDA for your combination product or constituent part?, paragraphs (b)(1) and (c)(1), eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ section- 4. 102 (read 8 November 2026) - 4Medical Devices; Reports of Corrections and Removals, final rule, FDA, 62 FR 27183, 19 May 1997, responses to comments 6, 7, 16, 17, 18, 20, 23, 24 and 29. https:/
/ www. govinfo. gov/ content/ pkg/ FR- 1997- 05- 19/ html/ 97- 13064. htm (read 8 November 2026) - 521 CFR 806.1, Scope, eCFR, last amended 1 April 2019. https:/
/ www. ecfr. gov/ current/ title- 21/ section- 806. 1 (read 8 November 2026) - 6Recalls, Corrections and Removals (Devices), FDA, content current as of 13 January 2025. https:/
/ www. fda. gov/ medical- devices/ postmarket- requirements- devices/ recalls- corrections- and- removals- devices (read 8 November 2026) - 7Distinguishing Medical Device Recalls from Medical Device Enhancements, guidance for industry and FDA staff, FDA, 15 October 2014, with its QMSR preface, sections IV, VI and VII. https:/
/ www. fda. gov/ media/ 89909/ download (read 8 November 2026) - 821 CFR 806.20, Records of corrections and removals not required to be reported, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ section- 806. 20 (read 8 November 2026) - 921 CFR 7.41, Health hazard evaluation and recall classification, paragraph (a), eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ section- 7. 41 (read 8 November 2026) - 1021 CFR 7.3, Definitions, paragraph (m), eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ section- 7. 3 (read 8 November 2026) - 1121 CFR 803.3, How does FDA define the terms used in this part?, definition of serious injury, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ section- 803. 3 (read 8 November 2026) - 1221 CFR 7.46, Firm-initiated recall, paragraph (a), eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ section- 7. 46 (read 8 November 2026) - 13Form FDA 5072, Device Correction/Removal Report for Industry, version 02/25, FDA, with its form instructions, recall contacts and event, strategy and product sections. https:/
/ www. fda. gov/ media/ 174165/ download (read 8 November 2026) - 14Medical Device Recalls and Reports of Corrections and Removals, Part 7, Part 806: Frequently Asked Questions, FDA, undated PDF (file created July 2026). https:/
/ www. fda. gov/ media/ 170726/ download (read 8 November 2026) - 1521 CFR 803.50, If I am a manufacturer, what reporting requirements apply to me?, paragraph (a), eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ section- 803. 50 (read 8 November 2026) - 16Medical Device Reporting for Manufacturers, guidance for industry and FDA staff, FDA, 8 November 2016, with its QMSR preface, section 2.14. https:/
/ www. fda. gov/ media/ 86420/ download (read 8 November 2026) - 17Contec Medical Systems Co., Ltd., warning letter, MARCS-CMS 717941, FDA, 2 October 2025. https:/
/ www. fda. gov/ inspections- compliance- enforcement- and- criminal- investigations/ warning- letters/ contec- medical- systems- co- ltd- 717941- 10022025 (read 8 November 2026) - 18Beta Bionics, Inc., warning letter, MARCS-CMS 717927, FDA, 28 January 2026. https:/
/ www. fda. gov/ inspections- compliance- enforcement- and- criminal- investigations/ warning- letters/ beta- bionics- inc- 717927- 01282026 (read 8 November 2026) - 19Sedecal S.A., warning letter, MARCS-CMS 707156, FDA, 5 May 2025. https:/
/ www. fda. gov/ inspections- compliance- enforcement- and- criminal- investigations/ warning- letters/ sedecal- sa- 707156- 05052025 (read 8 November 2026) - 20Happiest Baby, Inc., warning letter, MARCS-CMS 718306, FDA, 15 June 2026. https:/
/ www. fda. gov/ inspections- compliance- enforcement- and- criminal- investigations/ warning- letters/ happiest- baby- inc- 718306- 06152026 (read 8 November 2026) - 21Royal Philips, warning letter, MARCS-CMS 709948, FDA, 9 September 2025. https:/
/ www. fda. gov/ inspections- compliance- enforcement- and- criminal- investigations/ warning- letters/ royal- philips- 709948- 09092025 (read 8 November 2026) - 22Medical Devices; Reports of Corrections and Removals, direct final rule, FDA, 63 FR 42229, 7 August 1998, section I.B, History of Part 806. https:/
/ www. govinfo. gov/ content/ pkg/ FR- 1998- 08- 07/ html/ 98- 21091. htm (read 8 November 2026) - 23Regulation (EU) 2017/745 on medical devices, Article 2(68), Article 87(1) and (8) and Article 89(8), EUR-Lex. https:/
/ eur- lex. europa. eu/ eli/ reg/ 2017/ 745/ oj (read 8 November 2026) - 24The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, SI 2024/1368, regulation 1(2) and the regulation 44ZJ it inserts into the Medical Devices Regulations 2002, legislation.gov.uk. https:/
/ www. legislation. gov. uk/ uksi/ 2024/ 1368/ made (read 8 November 2026) - 25What is an Early Alert?, FDA, 29 September 2025. https:/
/ www. fda. gov/ medical- devices/ medical- device- recalls- and- early- alerts/ what- early- alert (read 8 November 2026)
AQuestions and answers
What happens after FDA receives an 806 report?
FDA reviews it and decides how to treat the action. If it is a recall, FDA tells you the class it has assigned, may recommend changes to your strategy, and lists the recall in its weekly Enforcement Report. You do not have to wait for that review before starting the correction or removal. FDA then asks for status reports, generally every two to four weeks, covering consignees notified and responding, product corrected or returned, and effectiveness checks, until it terminates the recall; you can ask for termination in writing with your latest status report.
Are 806 reports made public?
They are available for public disclosure under FDA’s freedom of information rules. Before releasing one, FDA deletes trade secrets and confidential commercial or financial information, and personal information such as the serial numbers of implanted devices. A patient who asks can still get the information in a report that concerns them, apart from trade secrets and confidential commercial information.
Do you need both an MDR and an 806 report for the same problem?
Often, yes. An MDR reports an adverse event or malfunction, and an 806 report covers the correction or removal you start in response. Starting the 806 action can itself create the MDR duty: FDA’s MDR guidance treats a malfunction as reportable when it leads you to take an action under section 519(g), the provision Part 806 implements, even if serious harm is remote. A report under Part 803 or Part 1004 replaces the 806 report only when it was a required report of the correction or removal itself. List the related MDR numbers in the 806 report.
Does filing an 806 report mean admitting the device caused harm?
No. The regulation says a report does not necessarily reflect a conclusion that the device caused or contributed to a death or serious injury, and the firm may deny that it does. FDA then decides how to treat the action: as a recall with a class, or, if it finds no risk to health, more likely as a market withdrawal.