Public regulatory and safety data, in one place

510(k) premarket notifications

178K records

A 510(k) is a premarket submission made to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

De Novo classification requests

493 records

The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.

PMA approvals

1,529 records

Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.

PMA supplements

57K records

A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.

HDE approvals

83 records

A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.

HDE supplements

1,883 records

An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.

Emergency Use Authorizations

891 records

Emergency Use Authorizations allow the FDA to permit unapproved medical products, or unapproved uses of approved products, during a declared public health emergency.

FDA device product codes

6,799 records

FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.

UDI device identifiers (GUDID)

5.2M records

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

EUDAMED devices

1.1M records

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

FDA device listings

263K records

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Drugs@FDA applications

29K records

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Drugs@FDA documents

123K records

Drugs@FDA posts the letters, labels, reviews and other documents behind each drug application and supplement. Orca1 indexes every document's full text and flags complete response letters.

Orange Book products

48K records

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

DailyMed drug labels

166K records

DailyMed publishes the structured product labeling (SPL) that companies submit to the FDA, including package NDCs, ingredients and the establishments that make each product.

National Drug Codes (NDC)

337K records

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

UNII substances

172K records

A Unique Ingredient Identifier (UNII) is the FDA's permanent identifier for a substance in regulated products, assigned through the Global Substance Registration System.

FDA Inactive Ingredient Database

9,071 records

The FDA Inactive Ingredient Database lists excipients in approved drug products by route and dosage form, with the highest potency per unit dose and, where published, the maximum daily exposure.

FDA drug shortages

4,419 records

The FDA Drug Shortages Database lists current and resolved shortages of drugs, with presentations, affected NDCs and reasons reported by manufacturers.

FDA-licensed vaccines

99 records

The FDA's CBER licenses vaccines for use in the United States. Each product page links the approval letters, package inserts and supporting documents for that vaccine.

Drug-drug interactions (DDInter)

141K records

DDInter is a curated database of drug-drug interactions. Orca1 shows only the two drugs and DDInter's interaction level; mechanism and management text are not reproduced.

MAUDE medical device reports

26.1M records

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

MAUDE brand safety profiles

564K records

Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.

MAUDE manufacturer and product code profiles

15K records

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

FAERS adverse event reports

16.6M records

FAERS holds adverse event and medication error reports submitted to the FDA. Reports are unverified, may be duplicated, and do not by themselves establish that a drug caused an event. Patient details and reaction terms are not shown.

Available in the Orca1 app

FAERS drug safety profiles

795K records

Drug profiles aggregate FAERS reports that name the drug as a suspect product. Reaction terms are counted but not listed here; reports are unverified and do not by themselves establish causation.

FAERS manufacturer and drug safety profiles

2.8M records

Manufacturer drug profiles aggregate the FAERS reports that one manufacturer sent to the FDA naming the drug as a suspect product, so the same drug can be compared across manufacturers. Reaction terms are counted but not listed here; reports are unverified and do not by themselves establish causation.

VAERS vaccine adverse event reports

2.6M records

VAERS collects reports of adverse events after vaccination. Anyone can submit a report, reports are unverified, and a report does not mean the vaccine caused the event. Symptoms, dates and patient details are not shown.

VAERS vaccine lot profiles

278K records

Lot profiles aggregate VAERS reports that name a specific vaccine lot. Symptom terms are counted but not listed here; reports are unverified and do not by themselves establish causation.

VAERS vaccine type profiles

104 records

Vaccine type profiles aggregate every VAERS report that names a vaccine of this type, across brands and manufacturers. Symptom terms are counted but not listed here; anyone can submit a report, reports are unverified, and a report does not mean the vaccine caused the event.

VAERS vaccine profiles

264 records

Vaccine profiles summarize the VAERS reports that name a vaccine product: its type, manufacturers and how many reports and lot numbers mention it. Anyone can submit a report, reports are unverified, and a report does not mean the vaccine caused the event. Symptoms and patient details are not shown.

VAERS manufacturer and vaccine profiles

348 records

Manufacturer vaccine profiles aggregate the VAERS reports that name one vaccine product from one manufacturer, the level at which vaccine safety signals are usually compared. Symptom terms are counted but not listed here; reports are unverified and do not by themselves establish causation.

International device safety notices

146K records

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

FDA device recall events

23K records

A recall event groups every recalled product (Z-number) from one recall action by a firm. Class I recalls involve a reasonable probability of serious harm; Class III recalls are unlikely to cause harm.

FDA device recalls (products)

60K records

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

FDA device recall notices and early alerts

263 records

The FDA's Medical Device Recalls and Early Alerts list covers the most serious device recalls, plus early alerts about potentially high-risk device issues while the FDA is still collecting information. A notice is updated as the recall is confirmed or changes.

FDA drug and product recalls

51K records

FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.

FDA warning letters

187K records

FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.

FDA inspections

964K records

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

CFR sections cited by the FDA

3,076 records

Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.

FDA compliance programs (program assignment codes)

67 records

FDA inspections and field assignments are planned under compliance programs. Each one is coded with a program assignment code (PAC) that ties it to a program in the FDA Compliance Program Guidance Manual (CPGM).

FDA establishments (FEI)

240K records

An FEI (FDA Establishment Identifier) is the number the FDA assigns to a site it inspects. FEIs of individual clinical investigators are not published here.

FDA inspection and compliance documents

41K records

The Orca1 document library indexes FDA compliance documents such as Form 483 observations, establishment inspection reports and firm responses. Documents are available to Orca1 subscribers only.

FDA FOIA requests

15K records

The FDA publishes logs of the Freedom of Information Act (FOIA) requests it receives. Orca1 links each request to the FDA establishments (FEIs) and premarket submissions it names. Requester names and the request text are not shown.

Health Canada inspections

30K records

Health Canada inspects establishments that conduct licensable activities with drugs, including good manufacturing practices (GMP) and pharmacovigilance (GVP) inspections. Clinical trial (GCP) inspections, which name individuals, are not published here.

MHRA GMP and GDP records

6,741 records

The MHRA issues good manufacturing practice (GMP) and good distribution practice (GDP) certificates and authorisations to UK and overseas sites and records statements of non-compliance.

EudraGMDP records

56K records

EudraGMDP is the EU database of manufacturing and import authorisations, GMP certificates, statements of non-compliance and wholesale distribution authorisations.

Swissmedic establishment licences

1,538 records

Swissmedic licenses establishments that manufacture, import, export or distribute medicinal products in Switzerland and records their GMP/GDP compliance status.

WHO prequalification inspections

1,091 records

WHO prequalification inspects manufacturers and contract research organizations whose medicines, vaccines and diagnostics are procured by UN agencies. Report documents are not reproduced here.

PMDA GMP inspections (Japan)

4,488 records

Japan's PMDA conducts GMP and QMS inspections of domestic and foreign manufacturing sites that supply the Japanese market.

PMDA registered foreign manufacturers (Japan)

20K records

Foreign manufacturers of drugs and medical devices supplied to Japan must be registered (accredited) with the Ministry of Health, Labour and Welfare through the PMDA.

PMDA approved drugs and package inserts (Japan)

21K records

Japan's PMDA publishes the package insert (添付文書) of every prescription drug, OTC drug and regenerative medical product, with brand and nonproprietary names, YJ codes and approval numbers. Names appear in Japanese as published.

PMDA medical device and IVD listings (Japan)

113K records

Medical devices and in vitro diagnostics sold in Japan are approved by the MHLW, certified by a registered certification body or notified, depending on class, and the PMDA publishes each product's package insert. Only identifiers, names and dates are shown here; package insert text and review reports are not reproduced.

Health Canada inspected establishments

9,350 records

Health Canada inspects the establishments that fabricate, package, label, test, import, distribute or wholesale drugs for the Canadian market. Clinical trial sites, which can name individuals, are not published here.

Health Canada regulation sections cited in inspections

273 records

Health Canada inspection reports cite the section of the Food and Drug Regulations, Medical Devices Regulations or Blood Regulations behind each observation. This page counts the published inspections that cite the requirement.

MHRA paediatric investigation plans

1,120 records

A paediatric investigation plan sets out the studies a company must run in children to support authorisation of a medicine in the UK, or records a waiver or deferral.

MHRA e-cigarette product notifications

34K records

Nicotine-containing e-cigarettes and refill containers must be notified to the MHRA before they can be sold in the UK.

EudraGMDP manufacturing and distribution sites

36K records

EudraGMDP identifies each manufacturing, import and distribution site by an EMA Organisation Management Service (OMS) location ID and lists the certificates and authorisations issued to it.

EU active substance (API) registrations

3,812 records

Companies in the EEA that manufacture, import or distribute active substances for human medicines must register with their national competent authority. EudraGMDP publishes each registration and the third-country sites that supply the substances.

ClinicalTrials.gov studies

571K records

ClinicalTrials.gov is the U.S. National Library of Medicine's registry of clinical studies conducted around the world. Contact and investigator details are not shown here.

WHO ICTRP trial registrations

542K records

The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.

Literature

153K records

Peer-reviewed and preprint literature indexed by Orca1 and linked to the FDA submissions and product codes each article mentions. Only bibliographic details are shown here.

Insurer medical policies

5,811 records

Insurer clinical and medical policies state when a payer covers a device, drug or procedure. Orca1 links each policy to the FDA submissions, trials and articles it cites. Policy text is not reproduced here.

Regulations.gov documents

214K records

Regulations.gov holds the rulemaking and other documents federal agencies post for public comment. Only agency documents are published here; public submissions are not.

FDA guidance documents

7,072 records

FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.

FDA-recognized consensus standards

1,886 records

The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.

ICH guidelines

149 records

ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.

IMDRF and GHTF documents

197 records

IMDRF is a forum of medical device regulators that writes harmonised guidance, such as the MDSAP audit documents and the UDI, SaMD and adverse-event terminology documents. It also hosts the archived documents of its predecessor, the Global Harmonization Task Force (GHTF).

MDCG guidance documents

169 records

The Medical Device Coordination Group (MDCG), made up of EU member-state experts, endorses guidance on applying the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746. Each page here covers one document and all of its revisions.

Global regulations and guidance

32K records

Regulations, guidance and official notices from medical device and medicines regulators worldwide, collected by Orca1 from each issuer's website. Only the title, issuer, date and link are shown here; the full text is searchable in Orca1.

NHSBSA freedom of information responses

1,378 records

The NHS Business Services Authority publishes its responses to freedom of information requests, with the released data files, on its open data portal. Request text and personal details are not shown here.

FDA device establishment registrations

29K records

Device establishments that manufacture, repackage, relabel or import devices for the U.S. market must register annually with the FDA and list the devices they produce.

FDA drug establishment registrations

10K records

Establishments that manufacture, repack, relabel or analyze drugs for the U.S. market register with the FDA each year. The registration lists the site's DUNS and FEI numbers and its business operations.

Companies (Orca1 company index)

232K records

The Orca1 company index (OMI) resolves the many spellings of a company's name across FDA, NLM and EU datasets into one profile, so every submission, recall, report and inspection rolls up to the right company.