CDRH New Update

		August 17, 2018
	The following new items were added to the CDRH web pages on August 16, 2018. Previous CDRH New items can be found on the CDRH New webpage. Draft Guidance Document: Process to Request a Review of Food and Drug Administration's Decision Not to Issue Certain Export Certificates for Devices MQSA Insights Article: Scrolling Through DBT Accreditation: Important Reminders Federal Register: Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting Program for Manufacturers Federal Register: Medical Devices; Classification of Accessories Distinct from Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments Federal Register: Process to Request a Review of Food and Drug Administration's Decision Not to Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN170052 added)