Medical Devices

Device Facility Registration & Listing

Medical device manufacturers and initial importers must register with FDA and renew annually. Firms that must register, also have t…

Device Facility Registration & Listing

Medical device manufacturers and initial importers must register with FDA and renew annually. Firms that must register, also have to pay users fees to FDA every year. Most companies that must register their facilities must also list their device with the FDA.

Medical device registration is critical to legally manufacturing and importing to devices in the US.

Who must register?

Device manufacturers, preparers, propagators, compounders, assemblers, and processors must register and submit listing information for their devices.

Initial importers also must register but they do not list devices.

An “initial importer” is the importer that furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer. Initial importers are not repackagers or those that otherwise change the container, wrapper, or labeling of the device.

User Fees: All registrations require an FDA User Fee. FDA adjusts these fees annually. The 2022 User Fee is $4,978 per registration.

Get Started

Free E-Book

Get Started

510k & pre-510k

We can help you classify your device and determine your premarket obligation. If there is a way to avoid a costly submission…

510k & pre-510k

We can help you classify your device and determine your premarket obligation. If there is a way to avoid a costly submission, we’ll help you find it. But, you do need to file, and we will help you prepare and submit it.

What is a 510k?

A 510(k) premarket submission is the primary pathway to bring new medical devices to market in the US. A 510(k) is not an approval, it is a clearance. FDA will review a 510(k) submission to determine whether a device is “substantially equivalent” to a device already cleared by FDA. This “already cleared” device is called a predicate device.

In general, a device is considered substantially equivalent if it has the same intended use and the same technology as the predicate device. A device can also be substantially equivalent if it has the same intended use(s) and a different technology that raises no questions of safety or effectiveness.

What is in a 510k? The 510(k) premarket submission includes technical, safety, and performance information about a medical device. The submission will need to include many items not limited to the following; device descriptions, predicate comparison, proposed labeling, shelf-life information, biocompatibility testing, electromagnetic/electrical safety data, bench testing, and performance testing. Do I need a 510k?

The first key to determining whether you need a 510(k) is to determine its classification. Almost all cleared devices have a corresponding regulation where the general type of device has already been cleared and classified. Devices are classified by their level of safety concern, from Class I, II, or III. This classification is noted in the regulation.

Most Class I devices are exempt from 510(k), except those that have intended uses that exceed their cleared regulation.

Most Class II devices require a 510(k), while most Class III devices require a Premarket Approval (PMA), which is a much more extensive and expensive filing.

Get Started

Free E-Book

Get Started

Label Review

Device labeling violations are the easiest enforcement action for FDA. We can help you modify your label to reduce the risk of …

Label Review

Device labeling violations are the easiest enforcement action for FDA. We can help you modify your label to reduce the risk of interference or enforcement by the Agency. Our clear and concise label review will provide you with clear directions for fixing your label, without clutter you don’t need.

Key Label Elements for OTC Devices

Statement of Identity – a statement of the common name of the device and its principal intended use.

Net Quantity Declaration – the quantity, weight, volume, or size of the product in the package.

Name & Address Declaration – this includes the legal name of the manufacturer, packer, or distributor and the address to their principal place of business.

Directions for Safe Use – directions necessary for the user to safely and effectively use the device. This can include frequency, quantity, duration of use, time and/or route of administration, and any preparation needed.

Unique Identifier – this is a code that identifies a device through its distribution.

Required Warnings – these are device specific, but can include warnings for products that expose consumers to latex or rubber, or special warnings for hearing aids, condoms, tampons, or emissions of ozone damaging chemicals.

Get Started

Free E-Book

Get Started

GMPs / QSRs

FDA requires manufacturers to establish and follow Quality System Regulations (QSRs) which detail current good manufact…

QSR / Inspection Response

FDA requires manufacturers to establish and follow Quality System Regulations (QSRs) which detail current good manufacturing practices (cGMPs) necessary to ensure that their products consistently meet applicable requirements and specifications. We can assist you in compliance with QSRs, as well as responding to an FDA facility inspection.

QSR Key Points

Basics of Quality Systems – QSRs are current good manufacturing practices for medical devices. They intended to maintain safety and quality of medical devices. QSR regulations cover a wide range of activities in the facility, including: personnel, design control, processes and production, traceability, labeling, and record keeping.

Design Controls – This part of the QSRs requires the manufacturer to establish and maintain procedures to manage design development, inputs, outputs, review, verification, validation, transfer, changes, and history.

Document Controls – These controls require the manufacturer to designate an individual to review the adequacy of and approve QSR documents.

Purchasing Controls – These controls require manufacturers to evaluate their suppliers’ quality controls and records.

I D & Traceability – This part of the QSRs requires the development of procedures to identify a device throughout the production process and, in the case of surgical implanted and life sustaining devices, provide controls numbers to provide traceability.

Production & Process Controls – This part of the QSRs requires the production, development, maintenance, and monitoring of processes and SOPs calculated to ensure that devices meet specifications.

Acceptance Activities – This part of the QSRs pertains to controls for receiving devices at the facility. They must include testing or inspecting the received devices and documentation of acceptance and rejection.

Nonconforming Products – QSRs require procedures to control non-conforming product, including identification, disposition, and documentation.

Corrective and Preventive Action – These QSRs require documentation of corrective and preventative actions related to nonconforming products or processes.

Labeling & Packaging – These are controls for the integrity, inspection, storage, and controls for labeling.

Handling, Storage, Distribution, and Installation – This part of the QSRs requires controls to ensure devices remain safe and effective beyond the manufacturing process.

Records – QSRs require the maintenance and control of records, including 2 years of retention, marking for confidentiality, master records, device history, quality system records, and maintenance of complaint files.

Servicing – When required manufacturers must establish and maintain procedures to verify that device servicing meets requirements.

Statistical Techniques – These QSRs require manufacturers to establish and maintain valid statistical techniques related to the acceptability of process capability and product characteristics.

FDA Inspections Once the FDA decides to inspect your device facility, you are legally required to allow them to enter and inspect. So, you must be prepared. Here are a few pointers for an FDA inspection:

FDA has authority to enter your facility at reasonable times to inspect.
FDA has the authority to sample products for testing. If they do, they will issue a Receipt for Sample (Form 484).
FDA has authority to inspect and copy your records related to compliance.
FDA does not have authority to inspect financials, sales, pricing information, or personnel data not related to a required qualification.
You are not required to sign FDA documents.

FDA will find flaws in your QSRs and compliance. FDA will note your non-compliance as “observations” in the 483 Inspectional Observations Report. You must respond to the observations in writing and correct the issues noted in the observations.

Get Started

Free E-Book

Get Started

Medical Device Reporting

Device manufacturers and importers are required to report certain device malfunctions and certain adverse events to FDA…

Medical Device Reporting

Device manufacturers and importers are required to report certain device malfunctions and certain adverse events to FDA in electronic format. This reporting is required when a device causes or may have caused death or serious injuries that are life threatening, cause permanent damage or damage necessitating surgery to avoid permanent damage. We can assist you in submitting reports as well as assessing your record keeping requirements.

What is Reported Responsible entities must report any deaths or serious injuries that a device has caused or may have caused. “Serious injuries” are injuries that are life threatening, cause permanent damage or damage necessitating surgery to avoid permanent damage.

Reports are submitted electronically using FDA Form 3500A. The form asks for significant detailed information about the patient (e.g., age, race, gender, and weight), the adverse event or product malfunction (e.g., outcome, date of event, date of report, etc.), a description of the product (e.g., model number, type, lot #, serial #, etc.), the type of reportable event, and the identity of the person filing the report.

Who must Report and When? Manufacturers must report adverse events and device malfunctions likely to cause or contribute to death or serious injury to FDA within 30 days of becoming aware of a reportable death, serious injury, or malfunction. Manufacturers must also report within 5 days after becoming aware of an event when FDA makes a written request or when a reportable event occurs that requires immediate remedial action to prevent an unreasonable risk of harm to the public.

Importers must report adverse events and device malfunctions to FDA and the manufacturer within 30 days after becoming aware. Importers must report device malfunctions to the manufacturer within 30 days after becoming aware

Recording Keeping Companies required to report must maintain records at their facility of all medical device reporting events. The required records are detailed, requiring all documents and deliberations in the reportability decision making process. Documents must be maintained for at least 2 years from the date of an event.

Get Started

Free E-Book

Get Started

Export Certificates to Foreign Governments

US device manufacturers exporting their devices sometimes need export certificates for inspection by foreign governments…

Export Certificates to Foreign Governments

US device manufacturers exporting their devices sometimes need export certificates for inspection by foreign governments. These certificates prove that the device is legal in the US, is compliant with US law, or was made in accordance with cGMPs. We can file these for your company.

Certificate to Foreign Government – this certificate demonstrates that the device can be legally marketed in the United States. To get this certificate the device must be cleared (510k, PMA, or exempt), be properly labeled, be made in accord with QSRs, be listed with FDA, and come from an FDA-registered facility.

Certificate of Exportability – 801(e)(1) – this certificate is for medical devices that are not cleared for sale in the US but are made in US facilities for export. This certificate will certify that the device is merely eligible for export from the US, which means that it is made to the foreign purchaser’s specs and not in conflict with the laws of the receiving country. In addition, such devices must not be offered for sale in the US and must be marked for export only.

Certificate of Exportability – 802 – this export certificate is for devices that are subject to special controls, require a PMA, or are investigational devices. This certificate certifies that the device has met foreign legal requirements, has met foreign purchaser’s specifications, and is in compliance with a number of key US requirements.

Non-Clinical Research Use Only Certificate – this export certificate is for non-clinical research products not intended for human use. This certificate will certify that the materials, products, or components are not for human use and are not offered for sale in the US.

Get Started

Free E-Book

Get Started

We can give you the experience you need!

Call us today for the results you deserve.

Call Now

Medical Devices

Device Facility Registration & Listing

510k & pre-510k

Label Review

GMPs / QSRs

Medical Device Reporting

Export Certificates to Foreign Governments

We can give you the experience you need!

Call us today for the results you deserve.

Industries

Services

Contact Us