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Easy Medical Device Equivalence Substantielle FDA procedure 510(k) Dispositif Medical

Le concept d’Equivalence Substantielle (de l’anglais “Substantial Equivalence”) existe depuis le milieu des années 1976 lorsque la procédure 510k a été créer.
Mais qu’est ce qu’une procédure 510k? (Je devrais l’écrire procédure 510(k), mais je préfère enlever les guillemets, cela fait plus business casual)

Qu’est ce qu’une procédure 510k

Une procédure 510k est une procédure de notification avant mise sur le marché (“Premarket Notification” en anglais) qui est décrit dans la réglementation 21 CFR 807 Subpart E.
Pour demander la mise sur le marché d’un dispositif médical:
  • Soit on trouve un produit déjà sur le marché Américain qui est substantiellement équivalent (Produit de référence) au notre (Class II) et qui nécessitera donc une procédure 510k; ou
  • On a un nouveau dispositif médical qui fera automatiquement partie de la classe III et qui nécessitera une procédure PMA (Premarket approval) our de Novo ou devra être reclassifié avant d’être mis sur le marché
Donc vous pouvez voir qu’avoir un produit de référence substantiellement équivalent est important pour réussir une procédure 510k.
Si vous n’arrivez pas à en trouver un ou à prouver que le votre est équivalent, alors vous devrez rentrer dans une procédure réglementaire plus contraignante.

Quand est-ce qu’une procédure 510k est requise?

On requiert une procédure 510k lorsque:
  • On met un produit sur le marché aux Etats-Unis pour la première fois
  • On modifie l’objectif principale ou la destination du dispositif déjà sur le marché
  • On souhaite faire des changements sur un Dispositif Médical qui peut affecter significativement la sécurité ou l’efficacité de celui-ci
Mais ce n’est pas nécessaire lorsque:
  • Un Distributeur en met le produit sur le marché en nom propre sans modifier le Dispositif Médical ou le contenu de l’étiquette ou ajoute le nom de l’entreprise ou du texte tel que “Distribué par…”
  • Ré emballage ou ré-étiquetage sans altérer le contenu de l’étiquette
  • Le produit n’est pas destiné à être vendu aux USA
  • On est fabriquant de composant

Le saviez-vous?

Pour chaque procédure 510k on attribue un “Numéro K” – la lettre K est suivi par 6 numéros. Si vous regardez ces numéros de plus prêt, vous verrez, les deux premiers chiffres indiquent l’année de soumission à la FDA. Les 4 numéros suivants sont séquentielles démarrant par 0 et indique l’ordre dans lequel la soumission a été reçu. Comme les procédures 510k ont démarrer en 1976, le premier est donc K760001. Le propriétaire de ce numéro est Zimmer (maintenant appelé Zimmer-Biomet). Une autre histoire est concernant le numéro K000001. C’est la première procédure 510k délivré en l’an 2000. Et le gagnant est Boston Scientific.

Maintenant que vous en savez plus sur la procédure 510k et surtout quand la démarrer, focalisons nous sur une grosse partie de cette procédure qui est “l’Equivalence Substantielle à un produit sur le marché”.

Pourquoi est-ce si important?

Démarrons avec quelques chiffres pour vous aider à mieux comprendre pourquoi vous devez réellement vous focaliser sur “l’Equivalence Substantielle”.
  • 75% des procédures 510k sont rejetées à la première tentative de soumission à la FDA
    • Sur ces rejets, 85% ont été spécifiquement rejetées à cause de l’Equivalence Substantielle durant la revue scientifique

C’est l’un des deux composants clés pour une procédure 510k

  • Pour réussir une procédure 510k vous devez montrer:
    • Une solide “Equivalence Substantielle”
    • Une solide stratégie d’atténuation des risques
Je pense qu’il ne faut surtout pas négliger cela. Les entreprises des dispositifs médicaux doivent prendre une grande inspiration et plonger dedans.
De notre côté plongeon dans la définition de l’Equivalence Substantielle.

Qu’est-ce qu’une Equivalence Substantielle?

Beaucoup d’entreprise pense que l’Equivalence Substantielle est quelque chose de basic et qu’il n’y a pas besoin d’y passer beaucoup de temps. Mais les statistiques parlent d’elle-même. Ce n’est pas si simple.

Quelle est la définition officielle de la FDA?

Définition de l’Equivalence Substantielle (en anglais): LINK
  • (i)(1)(A) For purposes of determinations of substantial equivalence under subsection (f) and section 520(l), the term “substantially equivalent” or “substantial equivalence” means, with respect to a device being compared to a predicate device, that the device has the same intended use as the predicate device and that the Secretary by order has found that the device
  • (i) has the same technological characteristics as the predicate device, or
  • (ii)(I) has different technological characteristics and the information submitted that the device is substantially equivalent to the predicate device contains information, including appropriate clinical or scientific data if deemed necessary by the Secretary or a person accredited under section 523, that demonstrates that the device is as safe and effective as a legally marketed device, and (II) does not raise different questions of safety and effectiveness than the predicate device.
  • (B) For purposes of subparagraph (A), the term “different technological characteristics” means, with respect to a device being compared to a predicate device, that there is a significant change in the materials, design, energy source, or other features of the device from those of the predicate device.

Comment interpréter la définition de l’Equivalence Substantielle?

Un Dispositif Médical doit être comparé à un dispositif légalement mis sur le marché Américain et qui ne requiert pas une procédure PMA.
Exemple:
  • Un dispositif de pre-amendment
  • Un dispositif reconnu par la FDA comme étant substantiellement équivalent
  • Un dispositif re-classifié
  • Un dispositif classifié par une procédure de Novo
Pour le département des Affaires Réglementaires ou les consultants travaillant sur une procédure 510k, ils ont besoin de définir à quelle point leur dispositif médical est équivalent aux dispositif déjà sur le marché qu’ils ont choisi. Comment peuvent-il faire?

Quelle est la raison d’un rejet?

La raison principale d’un rejet est simplement que vous n’avez pas réussi à convaincre la FDA. Si maintenant vous suivez ces conseils, vous devriez présenter vos données d’une manière plus structuré.
A la fin, ce n’est plus une question de juste ou faux. L’objectif sera uniquement de convaincre la FDA. Vous devez pouvoir vendre votre logique réglementaire. Vous devez vous transformer en commercial pour votre entreprise afin de mettre toutes les chances de votre côté. Mettez votre équivalence substantielle dans un paquet cadeau pour que l’agent qui la revoit soit conquis
Si vous n’êtes vraiment pas doué pour cela, vous pourriez être dérouté vers une procédure réglementaire plus contraignante pour votre entreprise ce qui ne serait pas bon du tout. Clairement, vous devez écrire une histoire et vous imaginez toutes les questions que l’agent pourrai se poser en la lisant.
Une astuce est de demander à quelqu’un de jouer à l’avocat du diable avec vous. Il va devoir trouver le moyen de rejeter votre dossier en vous posant les questions qui peuvent faire bloquer la procédure. Cela vous aidera à trouver vos points faibles ou à rendre votre dossier plus clair.

Voici un scénario possible

Imaginez ce scénario. Cela peut vous arrivez mais j’espère que cela restera uniquement de la fiction.
Vous informez votre responsable que vous êtes prêt à soumettre votre dossier 510k à la FDA pour votre produit phare que tous vos investisseurs et clients attendant avec impatience. Vous l’envoyez et voilà que le compte-à-rebours démarre. Jour après jour vous regardez si vous n’avez pas reçu de réponse. A chaque fois que vous voyez le mot FDA dans le sujet de vos emails vous pensez que c’est bon et en fait non.
Pendant ce temps l’équipe marketing peaufine ses brochures et ses campagnes. La logistique fait des plans quant au stockage et commence à signer des contrats avec les sous-traitants pour se réapprovisionner. Tous le monde est actif pour préparer le lancement.
Après quelques mois, enfin la réponse arrive. Vous l’ouvrez et il est écrit “We have the regret…”. Vous vous rappelez des emails ou lettres de refus que vous receviez lorsque vous postuliez à un job. C’est exactement pareil. Pas besoin de lire la suite vous avez compris.
Oh mon dieu! Ils ont rejeté le dossier. Quelle est la raison invoqué à votre avis? “L’Equivalence Substantielle”.
Si cela vous arrive réellement, c’est vraiment mauvais. Vous avez attendu si longtemps pour cela. Qu’est-ce que vous allez dire à tous le monde. Ils ont travaillé si dure pour que ce produit puisse être lancé. Est-ce que vous aviez anticipé ce scénario? Etes-vous capable de fournir une réponse immédiatement ou avez-vous besoin d’un ou plusieurs mois pour apporter la bonne argumentation?

Quelles sont les conséquences d’un rejet pour votre entreprise?

Les conséquences d’un rejet peuvent être:
  • Retard pour mettre votre produit sur le marché Américain
  • Perte financière (Pas de vente et des salaires à payer)
  • Risque d’être dévié vers une procédure PMA ou De Novo
Donc je vous conseille de vraiment prendre votre temps concernant cette section du dossier et de ne surtout pas la prendre à la légère. Ne pensez surtout pas que juste en mentionnant un produit concurrent similaire au votre, cela vous fera gagner le Jackpot.
Au lieu de prier pour que cela passe, faite tout votre possible pour que cela n’échoue pas.

Etape 1: Séparer les composants principaux

Beaucoup d’entreprise mélange la destination du produit avec la technologie lorsque l’on s’attaque à l’Equivalence Substantielle.
Une bonne pratique est de les traiter séparément.

La destination du produit

Premièrement, la FDA va vérifier que les deux dispositifs ont le même destination. Donc la méthode que je vous propose est de créer un tableau où l’on va comparer les deux produits.
Comme j’aime bien quand les choses sont visuelles, je vous recommande de surligner au marqueur les différents mots.
Par exemples à la façon d’un feu tricolore:
  • Vert: Les mots identiques et qui ont la même signification
  • Orange: Les mots identiques mais qui ont une signification légèrement différente
  • Rouge: Les mots qui sont complètement différent ou contraire et qui n’ont pas la même signification
Si vous voyez beaucoup de Vert, c’est bon signe. Mais si au contraire le Rouge est plus présent, peut être que votre produit de référence n’est pas le bon.
Par contre dans le cas où vous n’avez pas trouvé d’autre produit de référence similaire au votre, cela peut glisser assez rapidement vers une procédure “De Novo” plus contraignante.

Les caractéristiques technologiques

Après avoir fait la comparaison de la destination de votre produit avec le produit de référence, je crée le même type de tableau pour comparer les deux technologies. On utilisera la même méthode en surlignant avec différente couleurs les similarités ou les différences.
Une chose qui peut faire la différence c’est d’inclure des données chiffrées, de réaliser des tests ou d’identifier des plages de paramètres identiques pour les deux produits.
Plus vous montrerez que les deux produits sont similaires, plus vous pourrez solidifier votre position concernant l’Equivalence Substantielle.
Certaines entreprises ne se mettent pas à la place de l’agent américain qui va revoir votre dossier. Il a une tonne de fichier à analyser avec des pages et des pages de données à intégrer et interpréter. Et lui rendre la vie difficile n’est pas une bonne idée.
J’ai remarqué que certaines fois des dossiers sont envoyé uniquement avec des données brute, sans aucune explication. L’agent ne va pas essayer d’interpréter un tableau avec plein de chiffre. Il n’a pas que cela à faire.
Cela ne constitue pas une bonne pratique de la part de l’entreprise qui soumettent ce genre de dossier, mais pire cela donne vraiment une mauvaise image.

Présentation

Quand vous vous mettez à la place de l’agent de la FDA, vous aimeriez recevoir un dossier qui raconte une histoire. Cela voua aiderai grandement à comprendre ce qu’il est écrit.
Vous vous rappelez au lycée ou à l’université. Lorsque vous rédigiez des dissertations. Eh ben là c’est un peu la même chose.
  • Il faut une introduction décrivant le contexte et introduisant ce que vous voulez aborder.
  • Ensuite une partie développement  où il sera nécessaire de structurer votre argumentation en incluant vos tableaux de comparaison
  • Et enfin une conclusion qui devra être clair quant au fait que les deux produits sont substantiellement équivalent.

Tout cela doit être lisible et facile à comprendre. Si l’agent de la FDA est capable de tout comprendre du premier coup, vous avez tout gagné.

Etape 2: Analyser le Code Produit (Product Code en anglais)

Le second aspect que vous devez regarder c’est le Code Produit (“Product Code” en anglais) du produit de référence.
Si le code produit du produit de référence est ABC, alors votre produit doit aussi rentrer dans la catégorie ABC. Et pour cela il doit avoir les mêmes caractéristiques que le produit de référence.

Qu’est-ce que le Code Produit?

Le Code Produit décrit un produit spécifique et contient une combinaison de 5 à 7 chiffres et lettres. Le moyen le plus facile d’identifier le code produit est de vous familiariser avec le produit lui-même. Vous devez vérifier le label, les informations de fonctionnement, la destination du produit, le type d’emballage, qui va utiliser ou consommer le produit, etc.
Le code produit a 5 composants:
  • Industry code: Le code industriel est la catégorie dans laquelle le produit se trouve
  • Class code: Le code de classe est seulement 1 lettre et dépend de l’industrie
  • Subclass: C’est également 1 lettre pour la sous-classe. Cela décrit l’emballage principal qui est en contact et/ou qui supporte le produit
  • Process Indicator Code (PIC): C’est aussi 1 lettre. Les industries des Dispositifs Médicaux n’ont pas de PIC est celui-ci est représenté par un tiret.
  • Product (Group): 2 caractères avec des chiffres ou des lettres pour le produit. Correspond directement à une combinaison industrie/classification.

Exemple de Code Produit d’un dispositif médical (Traduit en Français)

Produit: Kit de premier secours contenant un produit pharmaceutique
Code Produit: 76–RR Product Code
StructureIndustrieClasseSous-classeProcess Identification Code (PIC)Produit
FormatNuméroLettreLettre or Tiret (-)Lettre or Tiret (-)Lettre ou Nombre
Echantillon79LTiret (-)Tiret (-)RR
SignificationGénérale & Chirurgie PlastiqueKitKit, Premier Secours

 

Lire aussi: Revue de toutes les informations FDA concernant le code produit LIEN
Il est important d’identifier le Code Produit de votre produit de référence et de souligner les similarités avec votre produit.
On continue dans le même sillage. On va faire tout notre possible pour que la FDA ne trouve pas d’argument contre notre Equivalence Substantielle.
 Easy Medical Device - Code Produit Dispositif Medical 510k

Etape 3: Est-ce vraiment la bonne classification?

Créer un paragraphe pour justifier pourquoi votre Dispositif Médical fait partie de cette classe.
C’est quelque fois évident de croire que le produit fait partie de la même classe que le produit de référence. Je vous recommande de le justifier même avec une phrase dans votre dossier. Cela va aider à le confirmer et également vous aider à mettre plus de poids dans le fait que les deux produits sont similaires.
Rappelez-vous. Notre objectif est de tout faire pour faire ressortir les similitudes et de diminuer le plus possible les différences. Ce que vous devez faire c’est de justifier les différences ou de les éliminer.

Etape 4: Quelles sont les règles pour le produit de référence ou “Predicate”

La réglementation demande que lors d’une procédure 510k vous devez avoir un produit de référence ou “Predicate”. Mais il n’est pas dit à quel point les produits doivent être similaires ou quel age ils doivent avoir. Ma préférence, bien-sûr, est d’avoir un produit de référence le plus proche possible du votre et le plus récent possible.
Exemple: Un produit de référence a été mis sur le marché il y a 1 ans et un autre il y a 10 ans. Si celui mis sur le marché il y a 10 ans est meilleur alors vous devez l’utiliser.
Mais une autre technique qui peut vous aider est d’expliquer dans votre dossier 510k que vous savez qu’un produit de référence presque identique a été mis sur le marché il y a 1 an. Et ensuite vous argumenter sur la raison pour laquelle vous n’aller pas l’utiliser pour votre dossier. Cela montrera à l’agent de la FDA que vous avez réellement fait une investigation du marché et pas seulement choisi n’importe quel produit.
Rappelez-vous, la réglementation ne dit pas quel age doit avoir le produit de référence. C’est à vous de décider. La réglementation ne vous tient pas par la main dans votre processus ce qui est une bonne chose. Nous avons encore la liberté de prendre le produit que l’on estime être le bon pour notre dossier.

Vulgarisation de l’Equivalence Substantielle

Pour ceux qui adorent les explications simples, on va utiliser des objets du quotidien pour comparer deux produits.
Imaginez que vous deviez mettre sur le marché une voiture et que vous souhaitiez utiliser un camion comme produit de référence pour votre Equivalence Substantielle. Comment feriez-vous?
D’abord voyons les similitudes.
Les deux ont:
  • Un moteur
  • Des roues
  • Une carrosserie
  • Des freins
  • Des sièges
  • Ils ont besoin de carburant
  • Ils ont besoin d’un conducteur
  • Roule sur la route
  • Ont des phares
  • Peuvent transporter des choses
Maintenant voyons les différences:
  • Une voiture a 4 roues quand un poids lourd en a au moins 8
  • La voiture utilise de l’essence alors que le camion que du diesel
  • Une voiture peut transporter quelques bagages alors qu’un camion des palettes de marchandise
  • Une voiture est plus légère qu’un camion
Apparemment, vous allez vous focaliser sur les similitudes. Mais si on veut réduire le fossé en terme de différence on peut aussi prendre comme produit de référence un plus petit camion. Une camionnette par exemple. C’est un mixe entre un poids lourd et une voiture mais ce sera quand même plus proche d’une voiture.

Bluffer avec l’Equivalence Substantielle

Easy Medical Device Equivalence substantielle 510k Bluff
En tant que commercial de votre entreprise, votre mission est de focaliser sur toutes les similarités et de faire que les différences ne soient pas remarquées ou négligeables.
Une possible stratégie est de ne surtout pas parler des différences.
Je vous dirai que c’est possible. Peut-être que l’agent de la FDA ne les remarquera pas. Mais si vous souhaitez emprunter ce chemin, je vous conseille quand même d’avoir un plan B. Travaillez quand même sur l’argumentation concernant les différences.
Dans le cas où l’agent reviendrai vers vous avec des questions concernant les différences, vous pourrez montrer votre professionnalisme et lui envoyer une réponse rapidement. Il ne faut surtout pas que l’agent ait déjà oublié votre dossier et qu’il soit passé à autre chose. Il faut qu’il reçoive une réponse qui lui enlève tout doute sans qu’il ai besoin de se rappeler encore une fois des détails.
C’est un jeu de bluff, mais c’est comme ça que ça marche. Les entreprises doivent certaines fois prendre des risques calculés mais les réduire au maximum afin de mettre toutes les chances de leurs côtés.

Comment aider les entreprises?

Pour résumer la stratégie:
  • Séparer la revue de l’argumentation sur la Destination du produit et sur les Caractéristiques Techniques
  • Inclure une analyse sur le Code Produit
  • Ne pas oublier de confirmer la classification
  • Prendre un produit de référence qui est le plus proche possible du votre même s’il a été mis sur le marché il y a plus de 10 ans
  • Si un produit plus récent a été mis sur le marché mais qu’il a moins de similarité, l’expliquer dans votre dossier
  • Raconter une Histoire pour vendre votre Equivalence Substantielle
  • Si vous souhaitez jouer un coup de bluff en omettant les différences, préparer quand même une argumentation au cas où l’agent reviendrai vers vous
En dernier lieu, rappelez-vous que votre dossier 510k peut être rejeté non pas parce que vous avez tort concernant les similarités de votre produit avec le produit de référence mais parce que vous n’avez pas réussi à convaincre la FDA.
J’espère que cet article vous a aidé à mieux comprendre l’équivalence substantielle lors de votre procédure 510k. Je vous souhaite beaucoup de sucés lors de vos soumissions à la FDA.

Référence:

Guide FDA: The 510k program: Evaluating Substantial Equivalence in Premarket Notification (Version July 28, 2014) LIEN
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Summary
4 Étapes pour Maîtriser l'Equivalence Substantielle
Article Name
4 Étapes pour Maîtriser l'Equivalence Substantielle
Description
Démontrer l'équivalence substantielle lors d'une procédure 510k à la FDA est toujours autant un problème pour les entreprises médicale. Je vais vous montrer comment survivre à cela et mettre toute les chances de votre côté pour que cela passe. Vous serez ensuite un maître en Equivalence substantielle
Author
Publisher Name
Easy Medical Device

Monir El Azzouzi

Expert en Dispositif Médical. Travaillant depuis plus de 10 ans dans le domaine de la Gestion de la Qualité, les Affaires Réglementaires, la Gestion de la conformité et les Nouvelles Innovation. Mon objectif est de transmettre mes connaissances et mon expérience à tous ceux qui travaillent dans le domaine des Dispositifs Médicaux.

UK Representative from January 1st, 2021

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