The present article outlines the key points related to the existing legal framework and explains the basics of the approach to be followed.
Daftar Isi
Grafik Food and Drug Administration (FDA atau Badan), otoritas pengatur produk kesehatan AS, telah menerbitkan rancangan dokumen panduan yang didedikasikan untuk karakterisasi lapisan logam dan/atau lapisan kalsium fosfat pada perangkat ortopedi.
Once finalised, the document will provide an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance to it.
Pada saat yang sama, ketentuan-ketentuan dalam pedoman ini bersifat tidak mengikat dan tidak dimaksudkan untuk memperkenalkan aturan-aturan baru atau memaksakan kewajiban-kewajiban baru.
Selain itu, pihak berwenang secara eksplisit menyatakan bahwa pendekatan alternatif dapat diterapkan, asalkan pendekatan tersebut sejalan dengan kerangka hukum yang ada. Hal ini telah disepakati dengan pihak berwenang sebelumnya.
Pengantar
The present draft guidance describes in detail the authority’s current position and recommendations for premarket submissions concerning orthopedic devices embellished with metallic and/or calcium phosphate coatings.
This document is addressed to industry stakeholders, outlining the expectations and review practices to ensure uniformity and expedite the review process.
The document also references the FDA-recognised voluntary consensus standards the parties involved may use when demonstrating compliance with the applicable regulatory requirements.
Such an approach reduces the regulatory burden faced by the parties interested in placing their products on the US market.
Lingkup dan Penerapan
The scope of this guidance is limited to Class II and Class III orthopedic devices that incorporate metallic and/or calcium phosphate coatings. The document elaborates on the characterizations of these coatings, which can be fabricated using various methods including but not limited to thermal spray, sintering, vapor deposition techniques, and additive manufacturing. It is important to note that the guidance explicitly excludes coatings containing drugs or biological materials and does not provide additional details on device-specific functional testing.
The guidance also provides a roadmap for compliance with specific regulatory frameworks and controls applicable to the devices under discussion.
It encourages adherence to the latest FDA-recognized consensus standards, emphasizing that such compliance is deemed to satisfy or even exceed the requirements outlined in unique controls.
Detailed Recommendations for Premarket Submissions
The document further provides detailed recommendations to be followed by the parties responsible for medical devices when preparing premarket submissions.
- Describing the Coating: In the context of premarket submissions, the authority expects the applicants to ensure a comprehensive delineation of the coatings applied to orthopedic devices.
This includes specifying the name and type of coating, the manufacturing processes employed, and a detailed account of the starting materials.
The document suggests including information on the physical structure of the coating, such as layering, thickness, and porosity, alongside engineering drawings to illustrate the coating’s coverage on the device.
This section is crucial for submissions involving coatings applied by third parties, recommending the inclusion of a letter of authorization from the master file holder to streamline the review process. - Sterilization Protocols: Acknowledging the critical importance of sterilization for implanted devices, the guidance emphasizes the necessity of presenting detailed sterilization protocols in premarket submissions.
It outlines the expectation for devices to be delivered sterile, emphasising the potential impact of end-user handling on the integrity and cleanliness of the coating.
The document outlines the sterilization methods, including a thorough description of the process, the validation of the sterilization cycle, and the specific considerations for different sterilization techniques such as radiation and chemical sterilants.
For devices coated with kalsium fosfat, the guidance recommends gamma radiation sterilization, referring to its historical clinical use and supporting data that attest to its compatibility with the coating properties.
It also addresses the need for presenting a rationale if alternative sterilization methods are proposed, ensuring they do not compromise the coating’s integrity or clinical efficacy.
Kesimpulan
The draft guidance describes the FDA’s efforts to establish an efficient and predictable premarket submission process for orthopedic devices with coatings.
It serves as a comprehensive resource for industry stakeholders, offering additional clarifications and recommendations related to compliance and regulatory approval procedures medical devices in question are subject to.
It is essential to mention that this guidance not only intends to streamline the review process but also contributes to public health protection by ensuring the reliability and sterility of orthopedic devices entering the market.
Bagaimana RegDesk Dapat Membantu?
Meja Registrasi adalah Sistem Manajemen Informasi Regulasi holistik yang memberikan informasi intelijen regulasi kepada perusahaan perangkat medis dan farmasi untuk lebih dari 120 pasar di seluruh dunia. Ini dapat membantu Anda mempersiapkan dan mempublikasikan aplikasi global, mengelola standar, menjalankan penilaian perubahan, dan mendapatkan peringatan real-time mengenai perubahan peraturan melalui platform terpusat. Klien kami juga memiliki akses ke jaringan kami yang terdiri lebih dari 4000 pakar kepatuhan di seluruh dunia untuk mendapatkan verifikasi atas pertanyaan-pertanyaan penting. Ekspansi global tidak pernah semudah ini.
Ingin tahu lebih banyak tentang solusi kami? Bicaralah dengan Ahli RegDesk hari ini!
->
- Konten Bertenaga SEO & Distribusi PR. Dapatkan Amplifikasi Hari Ini.
- PlatoData.Jaringan Vertikal Generatif Ai. Berdayakan Diri Anda. Akses Di Sini.
- PlatoAiStream. Intelijen Web3. Pengetahuan Diperkuat. Akses Di Sini.
- PlatoESG. Karbon, teknologi bersih, energi, Lingkungan Hidup, Tenaga surya, Penanganan limbah. Akses Di Sini.
- PlatoHealth. Kecerdasan Uji Coba Biotek dan Klinis. Akses Di Sini.
- Sumber: https://www.regdesk.co/fda-draft-guidance-on-metallic-or-calcium-phosphate-coatings-overview/
- :memiliki
- :adalah
- :bukan
- 1
- 120
- a
- Tentang Kami
- mengakses
- Akun
- Tambahan
- bahan tambahan
- manufaktur aditif
- dialamatkan
- alamat
- ketaatan
- memajukan
- badan
- sepakat
- Alerts
- di samping
- juga
- alternatif
- an
- dan
- berlaku
- pelamar
- aplikasi
- terapan
- pendekatan
- persetujuan
- ADALAH
- artikel
- AS
- Menilai
- penilaian
- kewenangan
- otorisasi
- Dasar-dasar
- BE
- menjadi
- beban
- tapi
- by
- CAN
- terpusat
- perubahan
- Perubahan
- kimia
- kelas
- klien
- Klinis
- Perusahaan
- kesesuaian
- pemenuhan
- luas
- kompromi
- komputasi
- tentang
- kesimpulan
- Konsensus
- pertimbangan
- dianggap
- mengandung
- konteks
- berkontribusi
- kontrol
- bisa
- liputan
- Kredibilitas
- kritis
- sangat penting
- terbaru
- siklus
- data
- dedicated
- dianggap
- disampaikan
- menunjukkan
- menjelaskan
- deskripsi
- rinci
- terperinci
- rincian
- alat
- Devices
- berbeda
- diskusi
- do
- dokumen
- tidak
- draf
- Gambar
- obat
- Obat-obatan
- kemanjuran
- efisien
- upaya
- menekankan
- menekankan
- menekankan
- dipekerjakan
- mendorong
- Teknik
- memastikan
- memastikan
- memasuki
- penting
- menetapkan
- Bahkan
- melebihi
- ada
- perluasan
- harapan
- harapan
- mengharapkan
- mempercepat
- ahli
- ahli
- Menjelaskan
- secara eksplisit
- dihadapi
- FDA
- File
- diikuti
- Untuk
- Kerangka
- kerangka
- dari
- fungsionil
- lebih lanjut
- Aksi
- ekspansi global
- bimbingan
- Penanganan
- Memiliki
- Kesehatan
- kesehatan
- membantu
- historis
- pemegang
- holistik
- HTTPS
- if
- ii
- iii
- menjelaskan
- Dampak
- pentingnya
- penting
- memaksakan
- in
- termasuk
- Termasuk
- penyertaan
- menggabungkan
- industri
- informasi
- integritas
- Intelijen
- dimaksudkan
- bermaksud
- tertarik
- memperkenalkan
- Pengantar
- terlibat
- melibatkan
- IT
- NYA
- jpg
- kunci
- Tahu
- Terbaru
- pelapisan
- Informasi
- kerangka hukum
- surat
- Terbatas
- baris
- mengelola
- pengelolaan
- sistem manajemen
- Produsen
- pabrik
- Pasar
- pasar
- menguasai
- bahan
- max-width
- Mungkin..
- medis
- alat medis
- Perangkat medis
- menyebut
- metode
- lebih
- nama
- Alam
- kebutuhan
- Perlu
- jaringan
- tak pernah
- New
- maupun
- mencatat
- obligasi
- memperoleh
- of
- menawarkan
- on
- hanya
- or
- Ortopedi
- Lainnya
- kami
- diuraikan
- menguraikan
- menguraikan
- lebih
- ikhtisar
- pihak
- Pharma
- fisik
- penempatan
- Platform
- plato
- Kecerdasan Data Plato
- Data Plato
- poin
- posisi
- potensi
- praktek
- Bisa ditebak
- Mempersiapkan
- mempersiapkan
- menyajikan
- menyajikan
- Prosedur
- proses
- proses
- Produk
- properties
- diusulkan
- perlindungan
- protokol
- memberikan
- disediakan
- menyediakan
- publik
- kesehatan masyarakat
- menerbitkan
- diterbitkan
- pertanyaan
- Pertanyaan
- Radiasi
- alasan
- real-time
- rekomendasi
- merekomendasikan
- merekomendasikan
- mengurangi
- referensi
- merujuk
- mengatur
- regulator
- persetujuan pengaturan
- terkait
- keandalan
- Persyaratan
- sumber
- tanggung jawab
- ulasan
- peta jalan
- aturan
- Run
- sama
- memuaskan
- cakupan
- Bagian
- melayani
- Sederhana
- Solusi
- sumber
- berbicara
- tertentu
- menentukan
- Disponsori
- stakeholder
- standar
- Mulai
- Negara
- mempersingkat
- struktur
- subyek
- pengajuan
- Submissions
- seperti itu
- Menyarankan
- pendukung
- sistem
- teknik
- pengujian
- bahwa
- Grafik
- Dasar-dasar
- mereka
- panas
- Ini
- mereka
- Ketiga
- Pihak ketiga
- ini
- teliti
- Melalui
- waktu
- untuk
- mengetik
- UGC
- bawah
- unik
- Serikat
- Amerika Serikat
- us
- menggunakan
- menggunakan
- pengesahan
- berbagai
- Verifikasi
- sukarela
- ingin
- BAIK
- ketika
- yang
- akan
- dengan
- industri udang di seluruh dunia.
- kamu
- zephyrnet.dll