F.A.Q

In the US, according to section 201(h) of Federal Food, Drug, and Cosmetic Act (FD&C Act),  a medical device is defined as:

“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

(1) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o).”

Reference: https://www.fda.gov/medical-devices/classify-your-medical-device/product-medical-device

Section 3060(a) of the 21st Century Cures Act (Cures Act) amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) on December 13, 2016, removing certain software functions from the definition of device in section 201(h) of the FD&C Act.

Specifically, Congress excluded the following software functions from the definition of device:

1. For administrative support of a health care facility, including the processing and maintenance of financial records, claims or billing information, appointment schedules, business analytics, information about patient populations, admissions, practice and inventory management, analysis of historical claims data to predict future utilization or cost-effectiveness, determination of health benefit eligibility, population health management, and laboratory workflow;
2. For maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;

   • Examples: Section V of General Wellness: Policy for Low Risk Devices Guidance for Industry and Food and Drug Administration Staff

3. To serve as electronic patient records, including patient-provided information, to the extent that such records are intended to transfer, store, convert formats, or display the equivalent of a paper medical chart, so long as: (i) such records were created, stored, transferred, or reviewed by health care professionals, or by individuals working under supervision of such professionals; (ii) such records are part of health information technology that is certified under section 3001(c)(5) of the PHSA; and (iii) such function is not intended to interpret or analyze patient records, including medical image data, for the purpose of the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition; and
4. For transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results, findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device, unless such function is intended to interpret or analyze clinical laboratory test or other device data, results, and findings
   • Example: Appendix A and B of Policy for Device Software Functions and Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff
   • Example: Non-Device-MDDS in Section 2 of Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Guidance for Industry and
     Food and Drug Administration Staff

Reference:

• https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf
• https://www.fda.gov/regulatory-information/search-fda-guidance-documents/changes-existing-medical-software-policies-resulting-section-3060-21st-century-cures-act

There are 3 classes of medical devices according to FDA’s definition.

• Class I Medical Devices

Class I medical device are those devices that have a low to moderate risk to the patient and/or user. There are non-exempted types and exempted types.

Today, 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process. If a device falls into a generic category of exempted Class I devices, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, the manufacturer is required to register their establishment and list their generic product with FDA. Examples include enema kits, elastic bandages, manual stethoscopes, and bedpans.

• Class II Medical Devices

Class II medical devices are those devices that have a moderate to high risk to the patient and/or user. There are also non-exempted types and exempted types.

43% of medical devices fall under this category. Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits.

• Class III Medical Devices

Class III medical devices are those devices that have a high risk to the patient and/or user. These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury.

They represent 10% of medical devices regulated by the FDA. Examples of Class III devices include implantable pacemakers and breast implants.

A 510(K) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)) that is not subject to premarket approval.

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of Class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing approval.

Please note that some Class III preamendment devices may require a Class III 510(k).

The FDA medical device manufacturer establishment registration requirement mandates that any establishment involved in the production, importation, reprocessing, relabeling, or developing specifications of a medical device or in vitro diagnostic device (IVD) for commercial sale in the United States must register annually with the FDA. This process is distinct from obtaining 510(k) clearance or Premarket Approval (PMA).

Key Requirements for Establishment Registration

Who Must Register

Establishments that manufacture, process, or distribute medical devices intended for commercial distribution in the U.S. must register. This includes foreign establishments exporting to the U.S. and domestic importers.

Annual Registration Fee

Establishments are required to pay an annual registration fee, which for fiscal year 2024 is $7,653 and will increase to $9,280 for fiscal year 2025[2]. There are no waivers or reductions in fees for small businesses or groups.

Device Listing

In addition to registration, establishments must list all devices manufactured at their facilities along with the activities performed on those devices. If a device requires a premarket submission before being marketed in the U.S., such as a 510(k), De Novo, PMA, PDP, or HDE, the submission number must also be provided.

Electronic Submission

All registration and listing information must be submitted electronically through the FDA’s Unified Registration and Listing System (FURLS).

Compliance with Regulations

The requirements are detailed under Title 21 CFR Part 807. Establishments must comply with these regulations to ensure their products can be legally marketed in the U.S.

The Fees for Fiscal Year 2025 (October 1, 2024 through September 30, 2025) are as follows:

† Small Business Fee: For businesses certified by the Center for Devices and Radiological Health (CDRH) as a small business.

‡ 510(k) Fees: All types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.

Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR, or BLA.

Annual Establishment Registration Fee: $9,280

There are no waivers or reductions for small establishments, businesses, or groups – all establishments must pay the establishment registration fee.

The Fees for Fiscal Year 2024 (October 1, 2023 through September 30, 2024) are as follows:

Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR, or BLA.

Annual Establishment Registration Fee: $7,653

There are no waivers or reductions for small establishments, businesses, or groups – all establishments must pay the establishment registration fee.

A general wellness product, has (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact
of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition. (“may help to reduce the risk of,” or “may help living well with,” a chronic disease or condition)

FDA does not intend to examine low risk general wellness products to determine whether they comply with the premarket review and post-market regulatory requirements for devices under the FD&C Act and implementing regulations, including, but not limited to: registration and listing and premarket notification requirements (21 CFR Part 807); labeling requirements
(21 CFR Part 801 and 21 CFR 809.10); good manufacturing practice requirements as set forth in the Quality System regulation (21 CFR Part 820); and Medical Device Reporting (MDR) requirements (21 CFR Part 803).

Reference: General Wellness: Policy for Low Risk Devices – Guidance for Industry and Food and Drug Administration Staff

• Illustrative Example 1: A software function plays music to “soothe and relax” an individual and to “manage stress.” Such a software function is not a device function.
• Illustrative Example 2: A software function that solely monitors and records daily energy expenditure and cardiovascular workout activities to “allow awareness of one’s exercise activities to improve or maintain good cardiovascular health.” Such a software function is not a device function.
• Illustrative Example 3: A software function monitors and records food consumption to “manage dietary activity for weight management and alert the user, healthcare provider, or family member of unhealthy dietary activity.” Such a software function is not a device function.
• Illustrative Example 4: A software function that reminds users to keep exposed skin out of direct sunlight when the UV index is high, which, as part of a healthy lifestyle, may help reduce the risk of skin cancer.
• Illustrative Example 5: A portable product that is intended to monitor the pulse rate of users during exercise and hiking.
• Illustrative Example 6: A product is intended to mechanically exfoliate the face, hands and feet to make the skin smoother and softer. The product cannot be used in a manner that penetrates or pierces the skin.

FDA FAQs on N95 Respirators, Surgical Masks, and Face Masks

https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/n95-respirators-surgical-masks-and-face-masks

FDA FAQ Medical Gloves for COVID-19

FDA FAQ on Medical Gowns

https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns

FDA FAQs on the EUAs for Non-NIOSH Approved Respirators

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-euas-non-niosh-approved-respirators-during-covid-19-pandemic

FDA Product Classifications for Surgical Masks & Respirators

FDA Classification for examination and surgical gloves

Take Nitrile Examination Glove (LZA) as an example, it is a Class I device however not 510K exempted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=2710