| In the last several months, a number of medical | | | | device(s). All 510(k)s must provide a comparison |
| device product companies and manufacturers | | | | between the device to be marketed and the |
| have contacted me with a similar question. The | | | | predicate device or devices already marketed. |
| question pertains to approval in Europe, Australia, | | | | A most important consideration is the predicate |
| Japan, Canada and how that relates to a US | | | | device. A company must identify a predicate |
| approval, and secondly, what type of 510(k) to | | | | device as a component of their clinical submission. |
| prepare in the US? Is there a fast track to | | | | That predicate device will be used as a source |
| approval in the US since they have device, | | | | comparison to your device at the time of clinical |
| detection and diagnostic non-US CE Marks of | | | | submission and regulatory review. The choice of |
| approval to market in non-US countries? There is | | | | the predicate device is crucial and I strongly |
| much debate with IVDMIA status, STED Pilot | | | | recommend that the 501(k) number of the |
| Programs and LDT clinical submissions, which does | | | | predicate device be identified in the clinical |
| not exist with Traditional, Abbreviated and Special | | | | submission - be transparent, be clear, be open. |
| 510(k) types of clinical submissions. The answer is | | | | Choose a device for your comparator that is |
| to understand and assess where you are, where | | | | similar to your device. You may claim SE to more |
| you want to go, and plan the most expeditious | | | | than one predicate. The predicate device of |
| way to get there while conducting activities in | | | | choice will and must be recently cleared and |
| accordance with FDA CDRH guidance and | | | | approved by FDA. There is additional guidance at |
| requirements. Assess the status of the device, | | | | the FDA website pertaining to "How to Find a |
| this means to assess the status as it relates not | | | | Predicate Device". |
| only to guidance and regulatory requirements, but | | | | Additional Steps to Aid in Management and |
| to assess the integrity and quality of data and | | | | Preparation: |
| documentation, statement, label, claim, | | | | - Locate Guidance Documents |
| completeness of application and submission, | | | | - Locate Design Control Requirements 21 CFR |
| intended use, omission, missing data and | | | | 820.30 |
| documentation, translation, standard for | | | | - Locate QS Regulation |
| development and quality review systems, | | | | - Locate Content and Format for the "Type" of |
| compliance to the Federal Register and otherwise. | | | | clinical submission to be filed.Components of a |
| Each medical device product will be reviewed | | | | Traditional 510(k), for example: |
| according to its intended use and if it relates to an | | | | - Form FDA 3601 |
| unmet medical need or emergent or life | | | | - PRS Cover Sheet |
| threatening serious need, but beware, these | | | | - Form FDA 3674 |
| applications are not easily regulated and approved | | | | - Cover Letter |
| and will be reviewed with regulatory rigor. | | | | - TOC |
| Yes, there are 3 types of PMA 510(k)s that may | | | | - Indications for Use |
| be submitted to FDA, Traditional, Special and | | | | - 510(k) Summary 21 CFR 807.92 or 510(k) |
| Abbreviated. The Special and Abbreviated | | | | Statement 21 CFR 807.93 |
| regulatory paths were developed under "The New | | | | - Standards Data Report Form FDA 3654 |
| 510(k) Paradigm" to help streamline the 510(k) | | | | - Truthful and Accuracy Statement 21 CFR |
| review process at FDA. The Special 510(k) and | | | | 807.87(k) |
| Abbreviated 510(k) regulatory methods can only | | | | - Class III Certification and Summary 21 CFR |
| be used if certain criteria are met. The Traditional | | | | 807.94.Items required under 21 CFR 807.87 |
| regulatory path can be used under any | | | | required for a PMA Notification are numerous, |
| circumstances. Information required at the time of | | | | please visit the Federal Register and create a |
| filing can be found in 21 CFR 807 Subpart E. | | | | checklist of submittable, required components as it |
| A 510(k) PMA Notification does not require a | | | | pertains to each device to ensure complete |
| "form" to complete for submission. There is no | | | | submissions and to minimize potential RTFs - |
| form. The 510(k) concept is based on substantial | | | | Refusal to File. |
| equivalence (SE) to a legally marketed (predicate) | | | | |