FDA / Regulatory Updates
The Abbreviated 510(k) submission program relies on the use of guidance documents, special controls, and FDA-recognized consensus standards to facilitate 510(k) review. The most important difference is that a medical device manufacturer shall demonstrate substantial equivalence with a guidance, standard or special control. Traditional 510(k) submission shall demonstrate substantial equivalence with an existing or predicate device.
Device manufacturers may choose to submit an Abbreviated 510(k) when the submission relies on:
- FDA guidance document(s),
- Demonstration of compliance with special controls for the device type, or
- Voluntary consensus standard(s).
In an Abbreviated 510(k) submission, medical device manufacturers would demonstrate that a new device meets FDA-identified performance criteria to show that the device is as safe and effective as a legally marketed device. 510(k) submitters still need to identify a predicate for certain aspects of substantial equivalence such as technological based criteria. However, instead of conducting direct comparison testing to demonstrate a device is as safe and effective as a predicate, manufacturers have the option to use this pathway demonstrate substantial equivalence, when appropriate.
The Safety and Performance Based Pathway is an expansion of the concept of the Abbreviated 510(k) pathway for certain, well understood device types.
The Safety and Performance Based Pathway is appropriate when the FDA has determined:
- The new device has the same indications for use as, and technological characteristics that do not raise different questions of safety and effectiveness than the identified predicate; and
- The new device meets all the FDA-identified performance criteria.
The following final guidance documents identify performance criteria and testing methodologies for device types that are appropriate for this pathway:
- Spinal Plating Systems
- Orthopedic Non-Spinal Metallic Bone Screws and Washers
- Magnetic Resonance Receive-Only Coils – eligible for 3P510(k), product code MOS
- Cutaneous Electrodes for Recording Purposes – eligible for 3P510(k), product code GXY
- Conventional Foley Catheters – eligible for 3P510(k), product code EZL
The short answer is NO. The FDA’s Center for Devices and Radiological Health (CDRH) does not issue any type of device registration certificates to medical device establishments.
If a manufacturer’s device falls into Class I devices as defined in 21 CFR Parts 862-892(exempt from 510(k)), a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, these manufacturers are required to register their establishment and list the generic category or classification name.
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States are generally required to register annually with the FDA. When a facility registers its establishment and lists its devices, the resulting entry in the FDA’s registration and listing database does not denote approval, clearance, or authorization of that facility or its medical devices.
When a business involved in the production and distribution of medical devices intended for use in the United States registers with the FDA, they do not receive a certificate from the FDA. The FDA does not issue any type of device registration certificates to medical device facilities.
How to Check if the FDA Approved, Cleared, or Authorized a Medical Device?
· Premarket Notification 510(k) Database
· PMA Approvals Database
· Denovo Database
